Clinical Trials in Spain 2026 - 222 Recent EU Authorisations

Colonization by methicillin-resistant S. aureus and gut microbiota in users of pre-exposure prophylaxis (PrEP) and people living with HIV (PLHIV) with STIs.
Instituto De Investigacion Marques De Valdecilla · 392 participants

📍 Spain

2025-525150-19-01 on CTIS ↗

Phase I/II Neoplasms Authorised 06/08/2026

Trial to study the safety, pharmacokinetics and preliminary antitumour activity of ODM-216 in patients with cancer

Advanced solid tumours
Orion Corporation · 104 participants

📍 Spain

2026-525864-17-00 on CTIS ↗

Phase III Immune System Diseases Authorised 05/08/2026

A Phase 3, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents with HIV who are Virologically Suppressed on ART

HIV Infections
Viiv Healthcare UK Limited · 81 participants

📍 Spain

2024-518511-19-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 04/08/2026

A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants with Idiopathic Pulmonary Fibrosis (IPF)) (ARGiNAUT)

Idiopathic Pulmonary Fibrosis
AstraZeneca AB · 109 participants

📍 Germany · Spain · Greece · Bulgaria · Italy · France · Denmark

2025-525016-41-00 on CTIS ↗

Phase I Not possible to specify Authorised 04/08/2026

Study in healthy volunteers to evaluate how the body processes Iadademstat and if food affects it

Healthy Volunteers
Oryzon Genomics S.A. · 30 participants

📍 Spain

2026-525953-35-00 on CTIS ↗

Phase I Neoplasms Authorised 04/08/2026

A study of enzomenib investigating potential drug-drug interactions and the effect of liver impairment in adult patients with advanced cancer

Advanced Cancer
Sumitomo Pharma America Inc. · 43 participants

📍 Spain · Bulgaria · Poland · Romania

2025-524652-63-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 03/08/2026

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron compared with Placebo in Adults with Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin (Eluminate-4)

type 2 diabetes mellitus
AstraZeneca AB · 183 participants

📍 Germany · Bulgaria · Spain · Denmark

2025-523940-12-00 on CTIS ↗

Phase III Neoplasms Authorised 03/08/2026

A Randomized Phase 2/3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination with Venetoclax and Azacitidine in Adult Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive Chemotherapy

Acute Myeloid Leukemia
AbbVie Deutschland GmbH & Co. KG · 25 participants

📍 France · Austria · Spain

2025-523724-47-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 03/08/2026

A double-blind, randomised, placebo-controlled trial evaluating the efficacy and safety of oral nerandomilast treatment in patients with systemic sclerosis (SSc)

Systemic sclerosis
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 124 participants

📍 Denmark · Sweden · Netherlands · Germany · Belgium · France · Greece · Norway · Finland · Czechia · Portugal · Bulgaria · Spain · Estonia · Lithuania

2025-523884-39-00 on CTIS ↗

Phase I Neoplasms Authorised 03/08/2026

Feasibility clinical trial of the sequential combination of AloCelyvir and activated tumor-infiltrating lymphocytes (TILs) for the treatment of children and young adults with advanced neuroblastoma

High-risk relapsed/refractory (R/R) neuroblastoma (NB).
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa · 15 participants

📍 Spain

2025-522006-21-00 on CTIS ↗

Phase III Immune System Diseases Authorised 03/08/2026

A Phase 3, Randomized, Double-blind, and Active‑controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ‑78934804 in Participants With Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
Janssen Cilag International · 194 participants

📍 Norway · Romania · Austria · Italy · Slovakia · Germany · Hungary · Netherlands · Belgium · France · Portugal · Czechia · Poland · Spain · Greece

2026-525922-39-00 on CTIS ↗

Phase III Immune System Diseases Authorised 03/08/2026

A Phase 3 Randomized, Double-blind, and Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis
Janssen Cilag International · 302 participants

📍 France · Bulgaria · Romania · Slovakia · Norway · Denmark · Greece · Italy · Austria · Poland · Netherlands · Czechia · Germany · Belgium · Spain · Hungary · Portugal

2026-525923-26-00 on CTIS ↗

Phase I Neoplasms Authorised 31/07/2026

A study to test how well different doses of BI 3822971 are tolerated by people with advanced cancer (solid tumours)

solid tumours
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 39 participants

📍 Spain

2026-525785-22-00 on CTIS ↗

Phase I/II Nervous System Diseases Authorised 30/07/2026

A Phase 1b/2a first-in-human, multicentre, randomized, double-blind, placebo-controlled study of multiple ascending dose (Part1) followed by an open-label extension (Part2) to assess the safety, tolerability, and pharmacokinetics of intrathecally administered S233107 in participants with spinocerebellar ataxia type 3

Spinocerebellar ataxia type 3
Institut De Recherches Internationales Servier IRIS · 50 participants

📍 France · Denmark · Spain · Portugal

2025-525111-17-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 30/07/2026

J3L-MC-EZEJ: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Lepodisiran to Investigate the Effect on Coronary Plaque in Adults With Elevated Lp(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event

Cardiovascular Diseases, Atherosclerosis, Lipoprotein(a)
Eli Lilly & Co. · 145 participants

📍 Hungary · Czechia · Spain · Netherlands

2025-524858-34-00 on CTIS ↗

Phase I Neoplasms Authorised 29/07/2026

A Phase 1a/1b, multicenter, open-label study evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PLN-101095 alone and in combination with pembrolizumab in adults with advanced or metastatic solid tumors following progression on immune checkpoint inhibitor therapy

Advanced or metastatic solid tumours
Pliant Therapeutics Inc. · 15 participants

📍 Spain

2026-526116-36-00 on CTIS ↗

Phase I/II Skin and Connective Tissue Diseases Authorised 29/07/2026

A Phase I/II, randomized, placebo-controlled, multi-arm, dose-finding study to evaluate the safety, efficacy and immunogenicity of an Acne mRNA vaccine candidate in adults with moderate to severe acne 18 to 45 years of age

Acne
Sanofi Pasteur Inc. · 189 participants

📍 Spain · Germany · Poland

2025-521740-38-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 29/07/2026

A Phase III, Randomized, Double-blind, Parallel-group, Placebo controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants with HFpEF and HFmrEF (Elevate-HF)

Heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF); on background SGLT2i.
AstraZeneca AB · 2343 participants

📍 Spain · Hungary · Germany · Poland · Italy · Bulgaria · Netherlands · Austria · Romania · Sweden · France · Greece · Slovakia · Czechia

2026-526304-79-00 on CTIS ↗

Phase II Neoplasms Authorised 28/07/2026

A Phase 2 Study of Alisertib in Combination with Paclitaxel in Patients with Small Cell Lung Cancer

Small Cell Lung Cancer (SCLC)
Puma Biotechnology Inc. · 30 participants

📍 France · Poland · Spain

2026-525382-47-00 on CTIS ↗

Phase IV Cardiovascular Diseases Authorised 28/07/2026

STRategiEs for Antiplatelet Management foLlowIng acute coroNary syndromE (STREAMLINE)

ischemic heart disease
Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz · 3500 participants

📍 Spain · Norway

2026-525933-22-00 on CTIS ↗

Phase I Neoplasms Authorised 27/07/2026

A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination with Bevacizumab in Adult Participants with Ovarian Cancer

Ovarian Cancer
AbbVie Deutschland GmbH & Co. KG · 44 participants

📍 Portugal · Denmark · Spain · France

2025-522209-40-00 on CTIS ↗

Phase I Neoplasms Authorised 27/07/2026

A Phase 1 Study of PRT12396 in Participants with Select Myeloproliferative Neoplasms

Post-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Intermediate-1, Intermediate-2, or High-Risk Primary Myelofibrosis, High-risk Polycythemia Vera
Prelude Therapeutics Inc. · 22 participants

📍 Italy · France · Spain

2026-525484-40-00 on CTIS ↗

Phase II Neoplasms Authorised 27/07/2026

A Cancer Research UK Phase II trial of CY-101 given via intratumoural administration in locally advanced or metastatic adrenocortical carcinoma (CLARITY)

LOCALLY ADVANCED OR METASTATIC ADRENOCORTICAL CARCINOMA
Cancer Research UK · 26 participants

📍 Spain · France · Germany · Norway

2025-522757-19-00 on CTIS ↗

Phase II Neoplasms Authorised 27/07/2026

A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination with Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer

Non-small Cell Lung Cancer
Janssen Cilag International · 6 participants

📍 Spain

2025-524816-13-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 27/07/2026

A clinical study to compare efficacy and safety of two different doses of CagriSema and semaglutide in participants with obesity with or without type 2 diabetes

Participants with obesity with or without type 2 diabetes
Novo Nordisk A/S · 1140 participants

📍 Greece · Portugal · France · Slovakia · Bulgaria · Netherlands · Romania · Italy · Austria · Poland · Hungary · Spain · Czechia · Belgium

2025-522488-14-00 on CTIS ↗

Phase III Neoplasms Authorised 27/07/2026

A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 versus Standard of Care in Subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC)

Small Cell Lung Cancer
AbbVie Deutschland GmbH & Co. KG · 125 participants

📍 Italy · Greece · Spain · Belgium · France · Austria · Germany

2025-523819-11-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 27/07/2026

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants with Obesity or Overweight with or without Type 2 Diabetes Mellitus (Embold)

Participants Living with Obesity or Overweight with at least 1 comorbidity with or without Type 2 Diabetes Mellitus
AstraZeneca AB · 1010 participants

📍 Spain · Germany · Italy · Poland

2025-524688-19-00 on CTIS ↗

Phase III Neoplasms Authorised 27/07/2026

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

Advanced or Metastatic HR+/HER2- Breast Cancer
BeOne Medicines I GmbH · 233 participants

📍 Poland · Italy · Germany · France · Spain

2025-523960-19-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 24/07/2026

An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Salanersen (BIIB115) in Participants Aged 15-60 Years With Spinal Muscular Atrophy Who Are Either Treatment-Naïve or Have Previously Been Treated With Risdiplam

Spinal Muscular Atrophy
Biogen Idec Research Limited · 40 participants

📍 Finland · Spain · Italy · Poland · Ireland · Germany · France

2025-524054-34-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 24/07/2026

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants with Chronic Kidney Disease (Elevate-CKD)

Chronic kidney disease (CKD) in adults, with specified ranges of eGFR and albuminuria (UACR), irrespective of T2DM status; background SGLT2i dapagliflozin 10 mg as GDMT.
AstraZeneca AB · 1600 participants

📍 Czechia · Italy · Hungary · Romania · Bulgaria · Sweden · Denmark · Poland · Spain · Norway · Finland · Greece · France · Germany

2025-523994-41-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 23/07/2026

IKF-099/D-FLOT-TNT Total Neoadjuvant Treatment with preoperative FLOT/Durvalumab plus postoperative Durvalumab for Resectable Gastroesophageal Adenocarcinoma

Gastroesophageal Adenocarcinoma
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH · 91 participants

📍 Germany · Spain

2026-525185-21-00 on CTIS ↗

Phase III Hormonal diseases Authorised 23/07/2026

A Phase 3b, Open-Label Study of Crinecerfont to Evaluate Androgen Reduction and Related Outcomes in Adults With Classic Congenital Adrenal Hyperplasia

Classic Congenital Adrenal Hyperplasia (CAH)
Neurocrine Biosciences Inc. · 71 participants

📍 Czechia · Germany · Sweden · Portugal · Romania · Bulgaria · Italy · Austria · Spain

2025-524282-24-00 on CTIS ↗

Phase III Not possible to specify Authorised 23/07/2026

Prospective, multicentre, open-label, single arm trial on contraceptive efficacy, safety and tolerability of LPRI-CF113 (Drospirenone 4 mg + 2.8 mg) during 13 cycles.

No medical condition
Chemo Research S.L. · 1550 participants

📍 Sweden · Czechia · Spain · Hungary · Poland · Finland · Romania

2026-525727-24-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 23/07/2026

A Phase 2/3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants with Huntington’s Disease

Huntington’s Disease
Skyhawk Therapeutics Inc. · 110 participants

📍 Germany · Spain

2025-522263-14-00 on CTIS ↗

Phase I/II Respiratory Tract Diseases Authorised 22/07/2026

A Phase 1/2, dose escalation and expansion study of TRI-611, an oral ALK molecular glue degrader in participants with advanced ALK-positive NSCLC

Advanced ALK-positive NSCLC
Triana Biomedicines Inc. · 4 participants

📍 France · Italy · Germany · Spain

2025-524418-27-00 on CTIS ↗

Phase IV Respiratory Tract Diseases Authorised 22/07/2026

Real-World Effectiveness of the Adjuvanted RSVPreF3 Vaccine in Adults ≥60 Years: A Pragmatic Randomized Trial (BronquiVal)

Respiratory syncytial virus infection–related respiratory disease
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana · 100000 participants

📍 Spain

2026-526804-59-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 22/07/2026

Colchicine for the Reduction of Dependency and Vascular Events after an Acute Intracerebral Hemorrhage (CoVasc-ICH2)

Major cardiovascular events (MACE), spontaneous intracerebral hemorrhage
Hamilton Health Sciences Corporation, PHRI Population Health Research Institute International · 312 participants

📍 Spain · Belgium

2025-523435-18-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 22/07/2026

Local and systemic immune modulation by Rilvegostomig (AZD2936) in the treatment of advanced gastric cancer (RILVE Project)

advanced gastric cancer
Vall D Hebron Institute Of Oncology · 38 participants

📍 Spain

2026-525620-23-00 on CTIS ↗

Phase I Neoplasms Authorised 22/07/2026

Tarlatamab Before and After Surgery for Recurrent High-Grade Glioma

surgically resectable recurrent high-grade glioma
Vall D Hebron Institute Of Oncology · 10 participants

📍 Spain

2025-524359-30-00 on CTIS ↗

Phase I/II Immune System Diseases Authorised 22/07/2026

A Phase 1/2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants with Refractory Rheumatoid Arthritis

Refractory, difficult-to-treat Rheumatoid Arthritis
Bristol-Myers Squibb Services Unlimited Company · 21 participants

📍 Poland · Italy · Spain · Germany

2025-520666-22-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 22/07/2026

A Phase 2, Multicenter, Randomized, Double-blind, Placebocontrolled Study, to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Intrathecally Administered Mivelsiran in Adult Participants with Early-Stage Down Syndrome-Associated Alzheimer’s Disease (DS-AD)

Early-Stage Down Syndrome-Associated Alzheimer’s Disease (DS-AD)
Alnylam Pharmaceuticals Inc. · 17 participants

📍 Italy · Netherlands · Spain · Germany · Ireland

2025-523390-42-00 on CTIS ↗

Phase I Neoplasms Authorised 21/07/2026

Phase 1/1b Study of BMS-986463 in Advanced Malignant Tumors

Advanced Malignant Tumors; High-grade Serous Ovarian Carcinoma (HGSOC), Uterine Serous Carcinoma (USC), Non-small Cell Lung Cancer (NSCLC)
Bristol-Myers Squibb Services Unlimited Company · 20 participants

📍 Spain · France · Italy

2025-523067-38-01 on CTIS ↗

Phase III Digestive System Diseases Authorised 21/07/2026

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis
Ipsen Bioscience Inc. · 127 participants

📍 Spain · Sweden · Germany · Romania · Finland · Portugal · Austria · Italy · Denmark · Czechia · France · Netherlands · Poland · Belgium · Norway

2026-525242-29-00 on CTIS ↗

Phase I/II Neoplasms Authorised 21/07/2026

A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and dose optimization study of GSK5471713 in adult participants with metastatic castration resistant prostate cancer (mCRPC).

Neoplasms, Prostate
Glaxosmithkline Research & Development Limited · 18 participants

📍 Netherlands · France · Spain

2025-523874-17-00 on CTIS ↗

Phase II Immune System Diseases Authorised 21/07/2026

A Phase 2, open-label, randomized, dose optimization study evaluating the efficacy and safety of belantamab mafodotin administered in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed amyloid light chain amyloidosis (ALANIS)

newly diagnosed amyloid light chain amyloidosis
Glaxosmithkline Research & Development Limited · 17 participants

📍 Italy · Greece · Spain

2025-522803-60-00 on CTIS ↗

Phase III Virus Diseases Authorised 21/07/2026

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination with Capsid Inhibitor Lenacapavir Twice Yearly in Virologically Suppressed Adults with HIV-1 Infection on Stable Oral Treatment Regimens

HIV-1
Gilead Sciences Inc. · 183 participants

📍 Poland · Italy · France · Spain · Germany · Netherlands

2025-524336-19-00 on CTIS ↗

Phase III Virus Diseases Authorised 21/07/2026

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

HIV-1
Gilead Sciences Inc. · 183 participants

📍 Netherlands · Poland · Germany · France · Spain · Italy

2025-524335-39-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 21/07/2026

A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice-daily Delgocitinib Cream in Adult Participants with Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period

Lichen Sclerosus
Leo Pharma A/S · 205 participants

📍 Italy · France · Spain · Poland · Germany

2025-524873-17-00 on CTIS ↗

Phase I Neoplasms Authorised 20/07/2026

Study of MX006 in Patients With Advanced and/or Metastatic Tumors known to express B7-H3

Advanced Solid Tumor Types Known to Express B7-H3
Myricx Pharma Limited · 40 participants

📍 Spain

2025-524929-41-00 on CTIS ↗

Phase II Cardiovascular Diseases Authorised 20/07/2026

A Phase IIb, randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy and safety of concomitant use of eplontersen and ALXN2220 compared with eplontersen and placebo in adult participants with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
AstraZeneca AB · 158 participants

📍 Germany · Italy · Spain · France · Sweden

2025-523908-75-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/07/2026

A randomized, placebo-controlled, double-blind Phase 3 study to evaluate the efficacy, safety and tolerability of votoplam in participants with Huntington’s Disease

Huntington’s Disease
Novartis Pharma AG · 368 participants

📍 Norway · Poland · Spain · Sweden · Bulgaria · Netherlands · Finland · Portugal · Austria · Italy · Greece · Ireland · Czechia · France · Romania · Belgium · Germany · Denmark · Slovakia · Hungary

2025-522227-99-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/07/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Narcolepsy Type 1
Alkermes Inc. · 116 participants

📍 Sweden · Finland · Belgium · Spain · Austria · Netherlands · France · Norway · Germany · Italy · Poland

2025-524711-36-00 on CTIS ↗

Phase III Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 17/07/2026

Intrathecal Administration of MELPIDA For Hereditary Spastic Paraplegia Type 50 (SPG50): A multicenter Phase 3, Open-Label Trial with Matched Prospective Concurrent Control Arm (CT-MEL-03)

Hereditary Spastic Paraplegia Type 50 (SPG50)
Elpida Therapeutics SPC · 12 participants

📍 Spain

2025-524576-28-00 on CTIS ↗

Phase II Cardiovascular Diseases Authorised 17/07/2026

An Open-Label Study to Assess the Hemodynamic Effect and the Safety of TX000045 After 16 Weeks of Treatment in Participants With Pulmonary Hypertension due to Interstitial Lung Disease

Pulmonary hypertension secondary to interstitial lung disease
Tectonic Operating Company Inc. · 9 participants

📍 Poland · Romania · Spain

2026-525810-80-00 on CTIS ↗

Phase I Nutritional and Metabolic Diseases Authorised 17/07/2026

Bioequivalence clinical trial of two formulations of dapagliflozin/metformin

Healthy participants
Laboratorios Alter S.A. · 36 participants

📍 Spain

2026-527164-32-00 on CTIS ↗

Phase III Neoplasms Authorised 15/07/2026

A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants with Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy

Relapsed or refractory large B-cell lymphoma (r/r LBCL)
Kite Pharma Inc. · 192 participants

📍 Belgium · Germany · Poland · Czechia · Netherlands · Spain · Italy · France

2025-524403-80-00 on CTIS ↗

Phase I/II Neoplasms Authorised 15/07/2026

Phase I/II clinical trial on the use of central nervous system administrations of CART-NKG2D or NKIL15 cells in children, adolescent and young adults with recurrent/refractory high grade Central Nervous System tumours (CINK-CAR)

Central nervous system tumours
Hospital Universitario La Paz · 30 participants

📍 Spain

2026-525876-24-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 14/07/2026

The MODIFY Study: A Phase 3b/4 randomized, double-blind, placebo-controlled, multicentre study evaluating the impact of early intervention with depemokimab on exacerbation rate, clinical remission, lung function decline, and safety in adults and adolescents with at risk Type 2 asthma, conducted up to 156 weeks.

Asthma
Glaxosmithkline Research & Development Limited · 229 participants

📍 Ireland · Spain · Germany · Czechia · Bulgaria · France · Belgium · Romania · Italy

2025-524463-20-00 on CTIS ↗

Phase III Neoplasms Authorised 14/07/2026

A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan with or Without Bevacizumab Compared to Trifluridine/Tipiracil plus Bevacizumab in Participants with Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

Metastatic colorectal cancer
Merck Healthcare KGaA · 323 participants

📍 Belgium · Germany · France · Denmark · Poland · Spain · Netherlands · Italy · Austria

2025-524648-37-00 on CTIS ↗

Phase III Female Urogenital Diseases and Pregnancy Complications Authorised 14/07/2026

A Sequential Phase 2/3, Single-Arm, Open-Label Study in Adults Followed by a Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults and Adolescents with Focal Segmental Glomerulosclerosis

Focal segmental glomerulosclerosis (FSGS)
Apellis Pharmaceuticals Inc. · 97 participants

📍 France · Portugal · Spain · Slovakia · Italy · Germany · Poland

2025-524448-36-00 on CTIS ↗

Phase III Digestive System Diseases Authorised 14/07/2026

RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma

Metastatic Pancreatic Adenocarcinoma
Revolution Medicines Inc. · 337 participants

📍 Poland · Belgium · Norway · Sweden · Austria · Germany · Denmark · Netherlands · France · Italy · Spain

2025-525088-34-00 on CTIS ↗

Phase II Immune System Diseases Authorised 13/07/2026

A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults with Antibody-mediated Kidney Disease

Antibody-mediated Kidney Disease
AstraZeneca AB · 17 participants

📍 France · Germany · Italy · Belgium · Poland · Spain

2025-524139-38-00 on CTIS ↗

Phase II Neoplasms Authorised 13/07/2026

A Phase 1b-2, Multicenter, Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of REC-4881 in Patients with Familial Adenomatous Polyposis (FAP)

Familial Adenomatous Polyposis
Recursion Pharmaceuticals Inc. · 20 participants

📍 Netherlands · Germany · Spain

2026-525282-50-00 on CTIS ↗

Phase IV Reproductive and Urinary Physiological Phenomena Authorised 13/07/2026

Phase IV randomized, single-blind clinical trial with three parallel arms to compare ovulation triggering strategies in IVF cycles with fresh embryo transfer.

Women with infertility and low ovarian reserve.
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA · 126 participants

📍 Spain

2026-526292-37-01 on CTIS ↗

Phase I Neoplasms Authorised 13/07/2026

A Phase 1 Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

Relapsed or Refractory acute myeloid leukemia, Relapsed or Refractory chronic lymphocytic leukemia, Relapsed or Refractory higher-risk myelodysplastic syndromes, Relapsed or Refractory small lymphocytic lymphoma
Janssen Cilag International · 175 participants

📍 France · Spain · Germany · Denmark · Belgium

2026-525234-39-00 on CTIS ↗

Phase II Virus Diseases Authorised 13/07/2026

Achieving viral CLEARance in immunocompromised participants with long-term persistence of SARS-CoV-2 - an open-label randomized trial (CLEAR)

Long-term persistence of SARS-CoV-2
Goethe University Frankfurt · 24 participants

📍 Germany · Spain

2025-524442-10-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 10/07/2026

Effect of Vitamin D supplementation on MyocardIal Fibrosis in PaTients with Acute Myocarditis (EDIT-AM): a multicenter, open-label, randomized controlled trial

Myocardial fibrosis, Acute myocarditis
Spanish Society Of Cardiology · 152 participants

📍 Spain

2025-523092-33-00 on CTIS ↗

Phase II Neoplasms Authorised 09/07/2026

A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement

Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement
Elevar Therapeutics Inc. · 14 participants

📍 France · Spain

2025-523923-22-00 on CTIS ↗

Phase II Immune System Diseases Authorised 08/07/2026

Master Protocol Full Title- A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis. ISA 2 to Master Protocol ARGX-999-2-MG-2000 – an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG
Argenx · 29 participants

📍 Greece · Italy · Germany · Belgium · Netherlands · Spain · Poland

2025-522939-33-00 on CTIS ↗

Phase III Eye Diseases Authorised 08/07/2026

A multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy (Beltavac®) with Polymerized Allergenic Extract of a Mixture of Dermatophagoides and Blomia tropicalis in Patients with Allergic Rhinitis/rhinoconjunctivitis.

Allergic rhinitis/rhinoconjunctivitis due to house dust mites exposure
Probelte Pharma S.L. · 174 participants

📍 Spain

2026-526105-15-00 on CTIS ↗

Phase III Neoplasms Authorised 08/07/2026

Fight Osteosarcoma Through European Research evolving study platform from diagnosis to relapse (FOSTER evolving study platform)

Osteosarcoma
Institut Gustave Roussy · 508 participants

📍 Sweden · Poland · Denmark · Finland · Netherlands · Italy · France · Spain

2023-505575-69-01 on CTIS ↗

Phase II Nervous System Diseases Authorised 08/07/2026

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults with Narcolepsy

Narcolepsy
Eisai Limited · 51 participants

📍 Belgium · Italy · Spain · Germany

2025-523503-30-00 on CTIS ↗

Phase II Neoplasms Authorised 07/07/2026

A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination with Other Agents in Participants with Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion

Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion
Bristol-Myers Squibb Services Unlimited Company · 123 participants

📍 Belgium · Ireland · Germany · Norway · Italy · France · Spain

2025-524285-18-00 on CTIS ↗

Phase III Eye Diseases Authorised 07/07/2026

Multicenter, randomized, double-blind, parallel-group clinical study comparing RD03/2016 (levoFloxacin and ketorolac trometAmol) eye drops vs Leviosa® (levofloxacin and dexamethaSone 21-phosphaTe) eye drops for 7 days for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults. (FAST 7)

Cataract
Ntc S.r.l. · 536 participants

📍 Spain · Poland · Greece · Sweden · Italy

2026-525594-39-00 on CTIS ↗

Phase III Neoplasms Authorised 07/07/2026

C6461016 - A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA

LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA
Pfizer Inc. · 91 participants

📍 France · Spain · Italy

2025-524717-86-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 07/07/2026

A study to evaluate the dose-exposure, safety, and exploratory efficacy of nerandomilast in children and adolescents from 2 years to less than 18 years of age with fibrosing interstitial lung disease (Part A: double-blind, placebo-controlled in children from 6 to less than 18 years of age and open-label active treatment in children from 2 to less than 6 years of age), followed by an open-label phase with active treatment (Part B)

Fibrosing interstitial lung disease
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 20 participants

📍 Belgium · Greece · Germany · France · Finland · Spain · Czechia · Poland · Italy · Netherlands · Denmark · Portugal

2025-523369-32-00 on CTIS ↗

Phase III Neoplasms Authorised 07/07/2026

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination with Pomalidomide and Dexamethasone Versus Standard of Care in Patients with Multiple Myeloma who Have Received One to Three Prior Lines of Therapy

Multiple Myeloma
F. Hoffmann-La Roche AG · 133 participants

📍 France · Germany · Italy · Greece · Denmark · Czechia · Spain · Poland

2025-524028-23-00 on CTIS ↗

Phase III Neoplasms Authorised 06/07/2026

Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan in Combination with FOLFOX Compared to Standard of Care in Subjects with First-Line Metastatic Pancreatic Ductal Adenocarcinoma - AndroMETa-PDAC-288

Metastatic Pancreatic Ductal Adenocarcinoma; PDAC
AbbVie Deutschland GmbH & Co. KG · 194 participants

📍 Portugal · Spain · France · Italy · Germany · Austria

2025-522563-15-00 on CTIS ↗

Phase I Bacterial Infections and Mycoses Authorised 06/07/2026

A study to investigate the repeat-dose pharmacokinetics of a combined oral contraceptive when given alone and in combination with ganfeborole in female participants of non-childbearing potential.

Tuberculosis
Glaxosmithkline Research & Development Limited · 28 participants

📍 Spain

2026-525790-39-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 06/07/2026

A Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multicenter study, to investigate the efficacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype

Respiratory tract diseases
Sanofi-Aventis Recherche & Developpement · 613 participants

📍 Denmark · Sweden · Poland · Estonia · Portugal · Latvia · Spain · Hungary · Germany · Finland · Italy · Belgium · France

2024-518016-39-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 06/07/2026

A Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multicenter study, to investigate the efficacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype

Respiratory tract diseases
Sanofi-Aventis Recherche & Developpement · 550 participants

📍 Germany · Romania · Greece · Norway · Netherlands · Poland · Lithuania · Czechia · Slovakia · Spain

2024-518213-25-00 on CTIS ↗

Phase III Mental Disorders Authorised 01/07/2026

AugmENtation witH cAnnabidiol iN first episode psyChosis: a doublE blind randomised controlled trial (STEP-ENHANCE Trial)

First Episode Psychosis (FEP)
University Of Oxford · 156 participants

📍 Netherlands · Greece · Germany · Italy · Austria · Spain

2025-521929-32-01 on CTIS ↗

Phase I/II Neoplasms Authorised 01/07/2026

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE849 in Patients with DLL3 Expressing Tumors Including Small Cell Lung Cancer

DLL3 Expressing Tumors Including Small Cell Lung Cancer
Ideaya Biosciences Inc. · 35 participants

📍 France · Spain

2025-523438-24-00 on CTIS ↗

Phase III Neoplasms Authorised 01/07/2026

"A Phase 3 Randomized Study Comparing JNJ-79635322 versus Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma after 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide"

Relapsed or Refractory Multiple Myeloma
Janssen Cilag International · 206 participants

📍 Poland · Spain · Czechia · France · Italy · Germany · Greece

2025-523815-12-00 on CTIS ↗

Phase I Immune System Diseases Authorised 01/07/2026

A Study to Evaluate Targeted Therapies for Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
AbbVie Deutschland GmbH & Co. KG · 19 participants

📍 Belgium · Netherlands · Spain · Germany · Italy

2025-523127-21-00 on CTIS ↗

Phase III Neoplasms Authorised 01/07/2026

A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L PlatinumBased Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)

Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)
Genmab A/S · 257 participants

📍 Finland · Belgium · Hungary · France · Denmark · Austria · Germany · Italy · Spain · Czechia · Norway · Poland

2025-522167-15-00 on CTIS ↗

Phase I/II Neoplasms Authorised 30/06/2026

A Phase 1/2 Study of Inhaled KB707 in Patients with Advanced Solid Tumor Malignancies Affecting the Lungs

solid tumor
Krystal Biotech Inc. · 40 participants

📍 France · Spain

2025-522723-98-00 on CTIS ↗

Phase II Neoplasms Authorised 30/06/2026

A phase IIa, single-arm, single-center, open label, proof-of-concept trial evaluating increased frequency dosing of VCN-01 (zabilugene almadenorepvec) in combination with nab-Paclitaxel/Gemcitabine (GnP) in Patients with Newly-Diagnosed Metastatic Pancreatic Cancer (VIRAGE2)

metastatic pancreatic adecarcinoma
Theriva Biologics S.L. · 6 participants

📍 Spain

2026-525566-21-00 on CTIS ↗

Phase III Neoplasms Authorised 30/06/2026

A Phase 3 Multicenter Double-blind Randomized Study of Taletrectinib Versus Placebo in Patients With ROS1-Fusion Positive Stage IB-IIIA Non-Small Cell Lung Cancer Who Have Undergone Complete Tumor Resection

Non Small Cell Lung Cancer (NSCLC)
Nuvation Bio Inc. · 45 participants

📍 Spain · Belgium · France · Italy · Germany

2025-521971-29-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 30/06/2026

A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease

Pulmonary Hypertension Associated with Interstitial Lung Disease
Insmed Inc. · 165 participants

📍 Greece · France · Italy · Belgium · Denmark · Germany · Poland · Czechia · Portugal · Austria · Spain · Romania

2025-521769-29-00 on CTIS ↗

Phase I/II Nervous System Diseases Authorised 30/06/2026

Phase 1-2, Open-Label, Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION337 in Patients with Dravet Syndrome

Dravet Syndrome
Ionis Pharmaceuticals Inc. · 12 participants

📍 Spain · France · Belgium · Portugal · Germany

2025-523835-20-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 30/06/2026

A Phase 2/3 Study to Characterize and Evaluate the Efficacy, Safety, and Tolerability of hu14.18K322A Treatment Given in Combination with Chemotherapy in Participants with High-Risk Neuroblastoma

Participants with relapsed HRNB and participants with HRNB refractory to treatment The clinical trial will recruit participants aged ≥18 months to <18 years, and therefore all participants will be minors at the time of consent.
Renaissance Pharma Limited · 111 participants

📍 Spain · France · Denmark · Ireland · Germany

2025-524397-42-00 on CTIS ↗

Phase I Not possible to specify Authorised 29/06/2026

A Phase 1 Randomized, Double-Blind, placebo-controlled, clinical study to evaluate safety and Pharmacokinetics, of Single Ascending Doses and Multiple Ascending Doses of AIK3a305 in Healthy Volunteers

Treatment of several inflammatory diseases, including inflammation-related fibrosis and autoinflammatory diseases
Allinky Biopharma S.L. · 42 participants

📍 Spain

2026-525830-49-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 29/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease
Merck Healthcare KGaA · 57 participants

📍 Germany · Romania · France · Bulgaria · Belgium · Spain · Poland · Greece · Italy · Czechia

2025-524855-30-00 on CTIS ↗

Phase III Immune System Diseases Authorised 29/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease
Merck Healthcare KGaA · 54 participants

📍 Spain · Belgium · France · Germany · Slovakia · Romania · Bulgaria · Italy · Poland · Greece

2025-523871-44-00 on CTIS ↗

Phase III Neoplasms Authorised 29/06/2026

AndroMETa-CRC-560: An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer

Colorectal Cancer
AbbVie Deutschland GmbH & Co. KG · 243 participants

📍 Greece · Portugal · Germany · Belgium · Spain

2025-521712-19-00 on CTIS ↗

Phase II Neoplasms Authorised 29/06/2026

C6461014 - A Phase 2 Interventional Study of PF-08634404 in Combination with Chemotherapy in Participants with Previously Untreated Transformed Small Cell Lung Cancer

Small Cell Lung Cancer
Pfizer Inc. · 15 participants

📍 France · Italy · Spain

2025-524686-24-00 on CTIS ↗

Phase IV Nutritional and Metabolic Diseases Authorised 29/06/2026

ObStructive Sleep Apnoea ManageMent in Older AdUlts with Overweight or ObEsity: A Randomized ClinicaL Trial (SAMUEL study)

Obstructive sleep apnea syndrome, Obesity
Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre · 345 participants

📍 Spain

2026-525500-10-00 on CTIS ↗

Phase II Neoplasms Authorised 29/06/2026

A Master Protocol of a Phase II, Open-label, Multicenter, Global Platform Study to Evaluate the Safety and Efficacy of Immunotherapy With or Without Other Anticancer Drugs in Participants with Unresectable Stage III Non-small Cell Lung Cancer Planning to Undergo Concurrent Chemoradiotherapy (AQUARIUS)

Non-small Cell Lung Cancer
AstraZeneca AB · 11 participants

📍 Spain · Germany

2025-523599-21-00 on CTIS ↗

Phase I/II Neoplasms Authorised 29/06/2026

A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) inhibitors in Combination with Ivonescimab with or without Other Anti-Cancer Agents in Patients with Solid Tumors

Solid Tumors
Revolution Medicines Inc. · 252 participants

📍 France · Poland · Ireland · Spain · Greece · Germany · Italy · Sweden · Belgium

2025-524623-50-00 on CTIS ↗

Phase II Immune System Diseases Authorised 29/06/2026

A Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MTX-474 in the Treatment of Participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Mediar Therapeutics Inc. · 36 participants

📍 Netherlands · Romania · Poland · France · Italy · Spain

2025-523288-39-00 on CTIS ↗

Phase III Neoplasms Authorised 26/06/2026

A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)

Pancreatic Ductal Adenocarcinoma
Incyte Corp. · 239 participants

📍 Poland · Italy · Netherlands · Sweden · Denmark · Finland · Spain · France · Germany · Belgium · Norway · Austria

2025-525009-18-00 on CTIS ↗

Phase II Disorders of Environmental Origin Authorised 26/06/2026

“In vivo” biological standardization of the allergenic extracts Dermatophagoides pteronyssinus (DPT) and Dermatophagoides farinae (DF) in patients sensitized to them.

IgE-mediated respiratory allergic disease due to the allergen whose extract is to be standardized, DPT and DF.
Probelte Pharma S.L. · 30 participants

📍 Spain

2026-525628-13-00 on CTIS ↗

Phase III Immune System Diseases Authorised 24/06/2026

A PHASE III, OPEN-LABEL, SINGLE-ARM, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND USE OF AN ON-BODY DELIVERY SYSTEM FOR THE SUBCUTANEOUS HOME ADMINISTRATION OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS

Multiple Sclerosis
F. Hoffmann-La Roche AG · 54 participants

📍 Spain · France · Poland · Italy

2025-523726-40-00 on CTIS ↗

Phase IV Female Urogenital Diseases and Pregnancy Complications Authorised 23/06/2026

The impact of ovarian stimulation with hMG on embryo quality in advanced age women. A randomized controlled trial

infertility
Santiago Dexeus Font Fundacio Privada · 240 participants

📍 Spain

2025-524761-25-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 23/06/2026

A Randomized, Double-blinded, Placebo-controlled, Parallel Group, Phase 2a Study to Assess the Activity, Safety, and Tolerability of SAR445399 in Adult Participants with Non-Cystic Fibrosis Bronchiectasis (NCFB).

Non-cystic fibrosis bronchiectasis
Sanofi-Aventis Recherche & Developpement · 41 participants

📍 Poland · Spain · France · Netherlands · Germany

2025-523403-29-00 on CTIS ↗

Phase IV Respiratory Tract Diseases Authorised 23/06/2026

USEFULNESS OF HIGH-FLOW OXYGEN THERAPY TO IMPROVE THE SAFETY OF PATIENTS AT HIGH RISK OF HYPOXEMIA UNDERGOING DIGESTIVE ENDOSCOPY UNDER DEEP SEDATION: A RANDOMIZED MULTICENTER COMPARATIVE STUDY. THE ENDOALF-TRIAL.

Hypoxemic episodes in patients undergoing gastroscopy, colonoscopy, or oral endoscopic ultrasound under deep sedation with oxygen therapy administration.
Hospital Universitario Rio Hortega · 326 participants

📍 Spain

2026-525766-21-01 on CTIS ↗

Phase III Immune System Diseases Authorised 22/06/2026

A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

Hereditary Angioedema
Adarx Pharmaceuticals Inc. · 45 participants

📍 Poland · Italy · Hungary · France · Austria · Czechia · Belgium · Spain · Bulgaria · Germany · Croatia

2025-521353-16-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 22/06/2026

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-Active Secondary Progressive Multiple Sclerosis

Non-active Secondary Progressive Multiple Sclerosis (SPMS)
Zenas Biopharma (USA) LLC · 467 participants

📍 Germany · Bulgaria · Netherlands · Sweden · Portugal · Croatia · Italy · Austria · Spain · Poland · France · Denmark · Hungary · Romania · Estonia · Slovakia · Belgium · Czechia · Norway · Lithuania · Greece

2025-524322-18-00 on CTIS ↗

Phase II Neoplasms Authorised 22/06/2026

An Open-label, Single-Arm, Phase 2 Study to Evaluate Enfortumab Vedotin plus Pembrolizumab for Bladder Preservation in Participants with Muscle-invasive Bladder Cancer (EV-209).

Muscle-invasive Bladder Cancer
Astellas Pharma Global Development Inc. · 88 participants

📍 Germany · France · Poland · Italy · Spain

2025-524488-18-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 22/06/2026

A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy with Cataplexy (Narcolepsy Type 1)

Narcolepsy with Cataplexy (NT1)
Takeda Development Center Americas Inc. · 69 participants

📍 Spain · Italy · France

2025-522587-33-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 22/06/2026

Effects of bempedoic acid/ezetimibe/high-intensity statin on plaque regression and stabilisation of coronary atherosclerosis among patients without cardiovascular events

Coronary atherosclerosis
Daiichi Sankyo Europe GmbH · 103 participants

📍 Italy · Spain · Germany

2025-524625-41-00 on CTIS ↗

Phase I Neoplasms Authorised 22/06/2026

Pharmacokinetics, safety, and immunogenicity comparison of Bmab1700 and Opdivo® as adjuvant monotherapy in patients with melanoma

Stage IIB/C, Stage III, or Stage IV Melanoma
Biocon Biologics UK PLC · 43 participants

📍 Spain · Romania

2025-525158-20-00 on CTIS ↗

Phase III Immune System Diseases Authorised 19/06/2026

A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants with Active Systemic Sclerosis (Breakfree-SSc)

Systemic Sclerosis
Celgene Corp. · 33 participants

📍 Spain · Germany · France · Italy

2025-524337-11-00 on CTIS ↗

Phase IV Nutritional and Metabolic Diseases Authorised 19/06/2026

Insulin resistance in type 2 diabetes: evaluating the pathogenic mechanisms of insulin resistance in the myocardium and the effects of the treatments with GLP-1RA and SGLT2i

Type 2 diabetes
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca · 60 participants

📍 Spain

2025-523374-17-03 on CTIS ↗

Phase I/II Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 18/06/2026

Long-term Follow-up (LTFU) Study of Participants in any iECURE Protocol Using an Investigational Product

Ornithine Transcarbamylase Deficiency (OTC)
Iecure Inc. · 3 participants

📍 Spain · France

2024-514190-21-00 on CTIS ↗

Phase I Male Urogenital Diseases Authorised 18/06/2026

A study to check whether adding RUTI® to standard BCG treatment for high-risk early-stage bladder cancer is safe and how it changes the body’s defenses, with participants randomly receiving RUTI® or a look-alike treatment.

High-risk non-muscle invasive bladder cancer (NMIBC)
Laboratorio Reig Jofre S.A. · 44 participants

📍 Spain

2026-525897-20-00 on CTIS ↗

Phase III Neoplasms Authorised 18/06/2026

Paclitaxel plus ramucirumab and tislelizumab as switch maintenance versus continuation of chemotherapy and tislelizumab in patients with advanced HER2-negative and PD-L1 positive gastroesophageal adenocarcinoma: the ARMANI-2/ENGIC08 trial by GONO

Advanced HER2-negative and PD-L1 positive gastroesophageal adenocarcinoma
Fondazione GONO G.I. · 212 participants

📍 Spain · Germany · Italy

2025-524048-36-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 18/06/2026

A randomized, double-blind, placebo-controlled, 104-week proof-of-concept study to evaluate the efficacy of intravenous prasinezumab in participants with Parkinson's disease carrying a severe mutation in the GBA gene (prevent cognitive decline in GBA-associated PD)

PARKINSON’S DISEASE
Universitaetsklinikum Tuebingen AöR · 110 participants

📍 Spain · Germany · Italy · Sweden · France · Luxembourg

2024-513496-40-00 on CTIS ↗

Phase I Neoplasms Authorised 17/06/2026

Phase 1/1b Study of RNDO-564 in Participants with Advanced Urothelial Cancer

Other Solid Tumors Associated with Nectin-4 Expression, Relapsed/Refractory Locally Advanced or Metastatic Urothelial Cancer
Rondo Therapeutics Inc. · 34 participants

📍 Spain

2025-524687-38-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 17/06/2026

IM0271016: An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants with Pulmonary Fibrosis

Progressive pulmonary fibrosis and Idiopathic pulmonary fibrosis
Bristol-Myers Squibb Services Unlimited Company · 318 participants

📍 Finland · Portugal · Hungary · Ireland · Poland · Greece · France · Belgium · Denmark · Italy · Spain · Netherlands · Austria · Germany

2025-522373-10-00 on CTIS ↗

Phase II Skin and Connective Tissue Diseases Authorised 17/06/2026

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Nemolizumab in Adult Patients with Systemic Sclerosis, including a 52-Week Main Treatment Period and a 156-Week Extension Treatment Period

Systemic sclerosis
Galderma S.A. · 56 participants

📍 Poland · Italy · Bulgaria · France · Greece · Spain · Croatia

2025-522294-11-00 on CTIS ↗

Phase I Neoplasms Authorised 16/06/2026

Open-label study of BBO-11818 in adult subjects with KRAS mutant cancer

Solid Tumors
Theras Inc. · 2999997 participants

📍 Spain · Italy · France

2025-524690-16-00 on CTIS ↗

Phase II Musculoskeletal Diseases Authorised 16/06/2026

A Phase 2, Open-Label Long-Term Extension Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon Skipping to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Efficacy of Endosomal Escape Vehicle Phosphorodiamidate Morpholino Oligomer Platform Products (ELEVATE-LTE)

Duchenne Muscular Dystrophy
Entrada Therapeutics Inc. · 56 participants

📍 Belgium · Italy · Netherlands · Spain

2025-525124-10-00 on CTIS ↗

Phase III Neoplasms Authorised 16/06/2026

A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug vedotin in Combination with Capecitabine with or without Rilvegostomig in First-line Claudin18.2-positive, HER2-negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer Expressing Claudin18.2
AstraZeneca AB · 516 participants

📍 France · Italy · Spain · Hungary · Poland · Belgium · Germany · Netherlands

2024-519787-40-00 on CTIS ↗

Phase I/II Neoplasms Authorised 16/06/2026

A Phase I/II Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6621, a T Cell-engaging Antibody That Targets STEAP2, CD3, and CD8 in Adult Participants With Metastatic Prostate Cancer (ACTIVATED-4-PC)

Metastatic Prostate Cancer
AstraZeneca AB · 45 participants

📍 Belgium · Spain · Poland · Italy · Netherlands

2025-520626-37-00 on CTIS ↗

Phase III Neoplasms Authorised 16/06/2026

A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)

Stage I NSCLC
Merck Sharp & Dohme LLC · 283 participants

📍 Greece · Poland · Italy · Hungary · Germany · Netherlands · France · Spain

2025-522643-18-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 16/06/2026

A Study to Evaluate the Long-term Safety and Efficacy of Long-acting Antibodies as Single Agents and in Combinations in Participants with Inflammatory Bowel Disease

Ulcerative colitis (Inflammatory Bowel Disease)
Spyre Therapeutics Inc. · 228 participants

📍 Croatia · Poland · Austria · Czechia · Italy · Slovakia · Bulgaria · Greece · Belgium · Spain · Hungary · Germany · Lithuania · France · Romania

2025-524640-35-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 15/06/2026

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of each of two dose levels of sarilumab in adults with early polymyalgia rheumatica

Musculoskeletal diseases
Sanofi-Aventis Recherche & Developpement · 177 participants

📍 France · Netherlands · Germany · Czechia · Belgium · Austria · Hungary · Greece · Spain

2024-511296-15-00 on CTIS ↗

Phase IV Immune System Diseases Authorised 15/06/2026

Real-World Effectiveness and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy (C3G) or Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN): A Multi-Country Study (PRISMC3)

Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), C3 Glomerulopathy (C3G)
Swedish Orphan Biovitrum AB (publ) · 69 participants

📍 France · Italy · Spain · Germany

2025-524487-37-00 on CTIS ↗

Phase III Neoplasms Authorised 12/06/2026

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)

Locally advanced, unresected (unresectable or medically inoperable or refuse surgery) Stage II-III NSCLC with KRAS G12C mutation
Merck Sharp & Dohme LLC · 88 participants

📍 Italy · Netherlands · France · Germany · Spain · Poland · Greece

2025-522038-29-00 on CTIS ↗

Phase III Neoplasms Authorised 12/06/2026

A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Relapsed/refractory B-cell Acute Lymphoblastic Leukemia
Merck Sharp & Dohme LLC · 109 participants

📍 Greece · Netherlands · Sweden · France · Italy · Spain · Denmark

2025-522267-15-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 12/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)

Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited · 210 participants

📍 Greece · Germany · Belgium · Netherlands · Poland · Italy · France · Spain · Bulgaria · Austria

2025-523674-16-00 on CTIS ↗

Phase I/II Immune System Diseases Authorised 11/06/2026

Phase I-IIa, national, multicenter, clinical trial to evaluate the safety and preliminary efficacy of CAR-T CD19 therapy in patients with refractory lupus nephritis.

Refractory Lupus Nephritis
Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz · 10 participants

📍 Spain

2025-522449-23-00 on CTIS ↗

Phase III Otorhinolaryngologic Diseases Authorised 11/06/2026

Evaluation of the Non-Inferiority of Topical Chloramphenicol Versus Topical Ciprofloxacin in the Resolution of Otorrhea in Adults With Chronic Suppurative Otitis Media (CSOM) – Protocol OMCOS

chronic suppurative otitis media (CSOM)
Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre · 88 participants

📍 Spain

2026-525540-15-00 on CTIS ↗

Phase II Neoplasms Authorised 11/06/2026

A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate Denikitug as Monotherapy or in Combination With Nivolumab or Chemotherapy in Participants With HER2-Negative, Unresectable, Recurrent, and/or Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas

HER2-negative, unresectable, recurrent, and/or metastatic gastric, GEJ, and esophageal adenocarcinomas
Gilead Sciences Inc. · 45 participants

📍 Spain · France

2025-524095-27-00 on CTIS ↗

Phase IV Digestive System Diseases Authorised 11/06/2026

Clinical trial to evaluate the correlation between variation in intestinal lactase activity measured with LacTEST 0.45g and alteration of intestinal barrier integrity and/or intestinal permeability in patients with celiac disease

Patients with celiac disease
Venter Pharma S.L. · 42 participants

📍 Spain

2026-525518-70-00 on CTIS ↗

Phase III Neoplasms Authorised 09/06/2026

A Phase 2/3 randomized, open-label study of MK-1045 in combination with rituximab in patients with 1L follicular lymphoma.

Follicular Lymphoma
Merck Sharp & Dohme LLC · 9 participants

📍 France · Spain · Greece

2025-522777-10-00 on CTIS ↗

Phase I/II Neoplasms Authorised 09/06/2026

A Phase 1/2, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients with Advanced KRAS G12D-Mutant Solid Tumors

Advanced KRAS G12D-Mutant Solid Tumors
Verastem Inc. · 210 participants

📍 Italy · France · Germany · Belgium · Spain · Netherlands

2025-523432-39-01 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 09/06/2026

Randomized, double-blind, parallel-group clinical trial, compared with placebo to evaluate the efficacy and safety of three antibiotic treatment regimens for the eradication of primary P. aeruginosa infection in patients with bronchiectasis

Bronchiectasis
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau · 160 participants

📍 Spain

2025-524454-34-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 08/06/2026

A Phase 2b/3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants with Moderate Calcific Aortic Valve STenosis (KATALYST-AV)

Moderate Calcific Aortic Valve Stenosis (CAVS)
Kardigan Inc. · 496 participants

📍 Norway · Czechia · Portugal · Austria · Poland · France · Spain

2025-522176-86-01 on CTIS ↗

Phase I/II Neoplasms Authorised 08/06/2026

A Phase 1b/2 Open-label Study Evaluating different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-based regimens in First-line Extensive Stage Small Cell Lung Cancer

Small cell lung cancer extensive stage
Merck Sharp & Dohme LLC · 79 participants

📍 Germany · Poland · Greece · Italy · France · Spain

2025-521032-11-00 on CTIS ↗

Phase II Skin and Connective Tissue Diseases Authorised 08/06/2026

A multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb study to assess the efficacy and safety of GIA632 in adult participants with non-segmental vitiligo followed by an extension period

Nonsegmental vitiligo
Novartis Pharma AG · 80 participants

📍 Germany · Spain · Netherlands · France · Italy

2025-522301-37-00 on CTIS ↗

Phase III Bacterial Infections and Mycoses Authorised 08/06/2026

PHASE III, OPEN-LABEL, RANDOMIZED, CONTROLLED, NON-INFERIORITY CLINICAL-TRIAL TO ASSESS THE EFFICACY AND SAFETY OF SHORT OUTPATIENT AMOXICILLIN REGIMENS IN CHILDREN WITH ACUTE STREPTOCOCCAL PHARYNGOTONSILLITIS (STOP – TRIAL)

ACUTE STREPTOCOCCAL PHARYNGOTONSILLITIS
Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus · 500 participants

📍 Spain

2026-525355-93-00 on CTIS ↗

Phase II Neoplasms Authorised 08/06/2026

A Phase 2, Open Label, Multicenter, Randomized Study, to Evaluate the Efficacy and Safety of Denikitug Monotherapy and Denikitug-based Combinations in Participants With Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC).

Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC)
Gilead Sciences Inc. · 94 participants

📍 Spain · Italy · France

2025-523984-39-00 on CTIS ↗

Phase III Digestive System Diseases Authorised 08/06/2026

Efficacy of sufentanil in urgent laparoscopic cholecystectomy: An alternative to the usual opioids for postoperative pain?

Laparoscopic cholecystectomy
Fundacion Biomedica Galicia Sur · 66 participants

📍 Spain

2026-525783-18-00 on CTIS ↗

Phase I/II Neoplasms Authorised 08/06/2026

A PHASE IB/II STUDY TO EVALUATE SAFETY AND EFFICACY OF BEXMARILIMAB IN COMBINATION WITH DOXORUBICIN IN METASTATIC SOFT-TISSUE SARCOMA (BEXAR Study)

Advanced or metastatic histologically confirmed soft tissue sarcoma (STS) in adult patients who are not candidates for curative treatment.
Medica Scientia Innovation Research S.L. · 278 participants

📍 Spain

2025-525144-18-00 on CTIS ↗

Phase III Neoplasms Authorised 08/06/2026

A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody Drug Conjugate (ADC), Compared to Investigator’s Choice Therapy in Participants with Relapsed Small Cell Lung Cancer

Small Cell Lung Cancer (SCLC)
Zai Lab (US) LLC · 234 participants

📍 Belgium · Czechia · Germany · Denmark · Greece · Netherlands · Poland · Spain · Austria · Italy · France

2025-522818-23-00 on CTIS ↗

Phase II Therapeutics Authorised 08/06/2026

Evaluating cognitive effects of a three month course of methylphenidate in Parkinson's disease patients with mild cognitive impairment.

Parkinson's disease
Universidad Rey Juan Carlos · 40 participants

📍 Spain

2026-525701-12-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 08/06/2026

C4531031 - AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Pfizer Inc. · 318 participants

📍 Spain · Germany · Poland · Czechia · Greece · Italy · Bulgaria · France · Hungary

2024-518587-12-00 on CTIS ↗

Phase I Neoplasms Authorised 08/06/2026

A study to learn more about how safe BAY 3771249 is and how well it works in people with advanced or metastatic colorectal cancer that has a KRAS G12D mutation

adenocarcinoma of the colon or rectum
Bayer Consumer Care AG · 49 participants

📍 Finland · Spain · Sweden · Italy · Denmark · Netherlands · Belgium

2025-523648-11-00 on CTIS ↗

Phase I/II Neoplasms Authorised 08/06/2026

KontRASt-R: An open-label, multi-center, rollover study for participants who have been previously enrolled into a Novartis-sponsored opnurasib (JDQ443) study and are continuing to benefit from opnurasib as a single agent or in combination with other study treatments

Locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer; advanced solid tumors harboring the KRAS G12C mutation.
Novartis Pharma AG · 31 participants

📍 Spain · Italy · France · Denmark · Belgium

2025-523537-26-00 on CTIS ↗

Phase II Virus Diseases Authorised 08/06/2026

Phase II, Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate The Safety And Efficacy Of Dasatinib To Reduce HIV-1 Reservoir, Chronic Inflammation, And Immune Senescence In People With HIV On Long-Term Antiretroviral Treatment.

HIV-1 infection
Instituto De Salud Carlos III · 60 participants

📍 Spain

2025-524363-20-01 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 08/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)

Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited · 173 participants

📍 Belgium · Greece · Poland · France · Spain · Bulgaria · Italy · Germany · Austria · Netherlands

2025-523675-39-00 on CTIS ↗

Phase II Behavioral Disciplines and Activities Authorised 08/06/2026

Phase II, Placebo-controlled trial of Cannabidiol for the treatment of alcohol dependence (PLACONCANALDE)

alcohol dependence
Hospital Universitario 12 De Octubre · 118 participants

📍 Spain

2023-504439-42-03 on CTIS ↗

Phase III Eye Diseases Authorised 05/06/2026

A randomized double-masked, multicenter, 3-arm, pivotal Phase 2/3 study to evaluate the efficacy and safety of intravitreal (IVT) EYE201/MK-8748 compared to aflibercept (2 mg) in participants with neovascular age-related macular degeneration (NVAMD)

Neovascular age-related macular degeneration (NVAMD)
Eyebiotech Limited · 250 participants

📍 Austria · Slovakia · Portugal · Czechia · Hungary · Spain · France · Denmark · Italy · Croatia

2025-524894-17-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 04/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2

Narcolepsy Type 2
Alkermes Inc. · 106 participants

📍 Spain · Netherlands · Belgium · Italy · France · Germany

2025-523912-35-00 on CTIS ↗

Phase I/II Nervous System Diseases Authorised 03/06/2026

A Phase 1b/2 Study to Evaluate NB-4746 in Participants with Amyotrophic Lateral Sclerosis.

Amyotrofic Lateral Sclerosis (ALS)
Nura Bio Inc. · 46 participants

📍 Poland · Netherlands · Italy · Spain

2025-523939-18-00 on CTIS ↗

Phase III Eye Diseases Authorised 03/06/2026

A randomized double-masked, multicenter, 3-arm, pivotal Phase 2/3 study to evaluate the efficacy and safety of intravitreal (IVT) EYE201/MK-8748 compared to aflibercept (2 mg) in participants with neovascular age-related macular degeneration (NVAMD)

Neovascular age-related macular degeneration (NVAMD)
Eyebiotech Limited · 130 participants

📍 Spain · Poland · Estonia · Latvia · Germany

2025-524575-22-00 on CTIS ↗

Phase I/II Neoplasms Authorised 02/06/2026

A Phase 1/2, Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic, and Antitumor Activity of CR-001 in Adult Participants with Locally Advanced or Metastatic Solid Tumors.

Locally Advanced or Metastatic Solid Tumors
Crescent Biopharma Inc. · 180 participants

📍 Spain · Ireland · Italy · France · Romania

2025-523590-42-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 02/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Narcolepsy Type 1
Alkermes Inc. · 75 participants

📍 Italy · France · Netherlands · Spain · Belgium

2025-523911-13-00 on CTIS ↗

Phase III Immune System Diseases Authorised 02/06/2026

Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)

Systemic lupus erythematosus
AstraZeneca AB · 108 participants

📍 Poland · Germany · Italy · France · Spain

2025-523670-17-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 01/06/2026

A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NXT007 PROPHYLAXIS VERSUS FACTOR VIII PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A WITHOUT INHIBITORS

Hemophilia A Without Inhibitors
F. Hoffmann-La Roche AG · 42 participants

📍 France · Austria · Poland · Netherlands · Spain · Denmark · Italy · Germany · Hungary

2025-522434-32-00 on CTIS ↗

Phase III Immune System Diseases Authorised 01/06/2026

Allergen extract of Lepidoglyphus destructor. Study of the sensitivity and specificity of the diagnostic preparation in prick tests

Allergy to Lepidoglyphus destructor
Inmunotek S.L. · 70 participants

📍 Spain

2025-523426-40-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 01/06/2026

A double-dummy, double-blind, randomized, active controlled, two-way cross-over study with 12-week treatment duration per period, to evaluate the efficacy and safety of QVM149 (indacaterol acetate / glycopyrronium bromide / mometasone furoate) compared to salmeterol xinafoate/fluticasone propionate in children from 12 years to less than 18 years of age with asthma.

Asthma
Novartis Pharma AG · 68 participants

📍 Poland · France · Slovakia · Spain · Hungary · Germany · Romania

2022-502365-26-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 01/06/2026

A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NXT007 PROPHYLAXIS VERSUS EMICIZUMAB PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A

Hemophilia A
F. Hoffmann-La Roche AG · 124 participants

📍 Hungary · Spain · Ireland · Poland · Austria · Germany · Denmark · Belgium · Netherlands · Italy · France

2025-522435-33-00 on CTIS ↗

Phase II Neoplasms Authorised 01/06/2026

Safety and efficacy of treatment combination with ponatinib and asciminib in chronic myeloid leukemia patients resistant to ponatinib and/or asciminib

Chronic Myeloid Leukemia
Grupo Espanol De Leucemia Mieloide Cronica (GELMC) · 30 participants

📍 Spain

2025-521126-15-00 on CTIS ↗

Phase III Neoplasms Authorised 01/06/2026

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma

Treatment-naїve mantle cell lymphoma (MCL)
Innocare Pharma Inc. · 102 participants

📍 Poland · France · Czechia · Spain · Romania

2025-524241-27-00 on CTIS ↗

Phase I/II Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 29/05/2026

An open-label, single-arm, phase 1/2 first-in-human study to assess the safety and efficacy of autologous CD34+ cells transduced with a lentiviral vector encoding the human NCF1 gene (SGX-001) in paediatric and adult patients with chronic granulomatous disease caused by p47phox deficiency

Chronic granulomatous disease (CGD) caused by p47phox deficiency (p47-CGD)
Somagenetix AG · 4 participants

📍 Germany · Spain

2025-524423-50-00 on CTIS ↗

Phase II Hemic and Lymphatic Diseases Authorised 29/05/2026

A PRECISION MEDICINE RANDOMIZED TRIAL FOR PATIENTS WITH RELAPSED OR REFRACTORY T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA BASED ON A FUNCTIONAL APPROACH. ALL-TARGET TRIAL

Relapsed/refractory T-cell Acute Lymphoblastic Leukemia
Centre Hospitalier De Versailles · 86 participants

📍 Germany · France · Czechia · Netherlands · Spain

2024-516570-30-00 on CTIS ↗

Phase I/II Neoplasms Authorised 29/05/2026

C6461006 - An Interventional Phase 1b/2, Open-Label Study to Investigate the Safety, Antitumor Activity, and Pharmacokinetics of PF-08634404 Monotherapy or in Combination With Enfortumab Vedotin in Adult Participants With Locally Advanced or Metastatic Urothelial Cancer.

Locally Advanced or Metastatic Urothelial Cancer
Pfizer Inc. · 36 participants

📍 Netherlands · Spain

2025-523523-21-00 on CTIS ↗

Phase III Neoplasms Authorised 29/05/2026

A Phase 3, Randomized, Double-Blind, Active-Control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients with Myelofibrosis who are JAK inhibitor naive

Myelofibrosis
Novartis Pharma AG · 173 participants

📍 Belgium · Germany · Austria · Poland · Spain · Italy · Netherlands · Czechia · France

2025-523555-66-00 on CTIS ↗

Phase II Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 29/05/2026

A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX‑828/Deutivacaftor With and Without Tezacaftor in Subjects Aged 18 Years and Older With Cystic Fibrosis

Cystic fibrosis
Vertex Pharmaceuticals Inc. · 80 participants

📍 Spain · Sweden · Germany · Italy · Belgium · Czechia · Ireland · Portugal · Netherlands · France · Denmark

2025-523400-72-00 on CTIS ↗

Phase II Neoplasms Authorised 28/05/2026

A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with Low Grade Upper Tract Urothelial Carcinoma (SURF303)

Low Grade Upper Tract Urothelial Carcinoma
Tyra Biosciences Inc. · 34 participants

📍 Bulgaria · France · Spain

2025-523539-20-00 on CTIS ↗

Phase I/II Neoplasms Authorised 28/05/2026

A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK‑1045 Monotherapy or in Combination with Other Anticancer Agents in Participants with Non-Hodgkin Lymphoma

Non-Hodgkin Lymphoma
Merck Sharp & Dohme LLC · 73 participants

📍 Poland · Italy · France · Germany · Spain

2025-523005-15-00 on CTIS ↗

Phase I/II Neoplasms Authorised 27/05/2026

A Phase I/II open label study of DJI136, a DLL3-targeted CAR-T therapy, in adult patients with ES-SCLC

Extensive stage small cell lung cancer
Novartis Pharma AG · 25 participants

📍 Spain · France

2025-523276-23-00 on CTIS ↗

Phase II Immune System Phenomena Authorised 27/05/2026

An Extension Study to Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients with Rheumatoid Arthritis who Participated in Previous Afimkibart Clinical Trials

moderate to severe rheumatoid arthritis (RA)
F. Hoffmann-La Roche AG · 46 participants

📍 Italy · Spain · Germany · France · Denmark · Poland · Belgium

2025-523579-47-00 on CTIS ↗

Phase III Immune System Diseases Authorised 27/05/2026

A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab versus Risankizumab in the Treatment of Participants with Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
Janssen Cilag International · 302 participants

📍 Slovakia · Germany · Denmark · France · Spain · Italy · Netherlands · Belgium · Poland · Sweden · Austria · Czechia · Hungary

2025-521590-13-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 26/05/2026

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of a Single Intravenous Dose of SGT-003 in Ambulant Males With Duchenne Muscular Dystrophy

Duchenne muscular dystrophy
Solid Biosciences Inc. · 62 participants

📍 Spain · Netherlands · France · Italy · Belgium · Germany

2025-522949-22-00 on CTIS ↗

Phase I/II Neoplasms Authorised 26/05/2026

LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

Neoplasm malignant
Merck Sharp & Dohme LLC · 22 participants

📍 France · Spain · Sweden · Germany · Italy · Belgium · Denmark · Hungary

2025-522339-32-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 26/05/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma

Severe uncontrolled asthma
Generate Biomedicines Inc. · 80 participants

📍 Italy · Slovakia · Spain · Ireland · Belgium · France · Estonia

2025-524040-35-00 on CTIS ↗

Phase III Immune System Diseases Authorised 25/05/2026

D. pteronyssinus and D. farinae allergen extracts. Study of the sensitivity and specificity of the prick test diagnostic preparation

Allergy to Dermatophagoides pteronyssinus, Allergy to Dermatophagoides farinae
Inmunotek S.L. · 70 participants

📍 Spain

2025-522469-31-00 on CTIS ↗

Phase II Hemic and Lymphatic Diseases Authorised 25/05/2026

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma (r/r MM)

relapsed/refractory multiple myeloma
C4 Therapeutics Inc. · 43 participants

📍 Italy · France · Spain · Poland

2025-524181-26-00 on CTIS ↗

Phase I Immune System Diseases Authorised 22/05/2026

A study to test single and multiple doses of MER511 given to adults with Graves’ disease

Graves’ disease
Merida Biosciences Inc. · 28 participants

📍 Spain

2025-523823-23-00 on CTIS ↗

Phase III Neoplasms Authorised 22/05/2026

ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy

Unresectable Stage III non-small cell lung cancer without progression
Bristol-Myers Squibb Services Unlimited Company · 279 participants

📍 France · Ireland · Germany · Greece · Bulgaria · Spain · Netherlands · Italy · Sweden · Romania · Hungary · Belgium · Austria · Poland

2025-523576-23-00 on CTIS ↗

Phase I/II Neoplasms Authorised 22/05/2026

A 2-part phase 1/2 open-label trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 in combination with anti-cancer therapy in participants with advanced solid tumours

Neoplasms benign malignant and unspecified (incl. cysts and polyps)
Orion Corporation · 85 participants

📍 Finland · Denmark · Spain · France

2025-524620-22-00 on CTIS ↗

Phase II Neoplasms Authorised 21/05/2026

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).

Stage 4 (IV) Non-Small Cell Lung Cancer (NSCLC)
Eikon Therapeutics Inc. · 115 participants

📍 Germany · Spain · Netherlands · Romania · Greece · Italy

2025-525013-23-00 on CTIS ↗

Phase II Metabolism Authorised 21/05/2026

An open-label, single-arm extension study to evaluate the long-term safety, tolerability, and efficacy of KL1333 (napazimone) in patients with primary mitochondrial disease

Adult patients with primary mitochondrial disease
Pharming Technologies B.V. · 96 participants

📍 Belgium · Germany · Czechia · Spain · Denmark · Italy · France

2025-524367-20-00 on CTIS ↗

Phase I Neoplasms Authorised 21/05/2026

First time in human (FTIH) study to investigate the safety and preliminary activity of GSK5533524 alone or in combination in adult participants with advanced solid tumors

Neoplasms
Glaxosmithkline Research & Development Limited · 52 participants

📍 Spain · Denmark · Finland · France

2025-524165-25-00 on CTIS ↗

Phase II Eye Diseases Authorised 20/05/2026

An Open-Label, Rollover Study for Participants With Thyroid Eye Disease Previously Enrolled in Amgen-Sponsored AMG 732 Studies and are Primary Proptosis Non-responders or who Relapsed During the Safety Follow-up

Thyroid Eye Disease
Amgen Inc. · 8 participants

📍 Spain · Poland · France · Italy

2025-523280-38-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 20/05/2026

An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored remibrutinib study and are judged by the investigator to benefit from continued treatment with remibrutinib

Chronic Spontaneous Urticaria
Novartis Pharma AG · 154 participants

📍 Germany · Spain · France · Poland · Bulgaria · Czechia

2025-524078-40-00 on CTIS ↗

Phase III Immune System Diseases Authorised 20/05/2026

A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa

Hidradenitis Suppurativa (HS)
Novartis Pharma AG · 307 participants

📍 Portugal · Greece · Germany · Hungary · France · Spain · Bulgaria · Slovakia · Poland · Czechia · Belgium · Italy

2025-523259-72-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 20/05/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous AOC 1044 (delpacibart zotadirsen) for the Treatment of DMD with Gene Mutations Amenable to Exon 44 Skipping

Duchenne muscular dystrophy
Avidity Biosciences Inc. · 42 participants

📍 Italy · Germany · France · Spain · Belgium · Poland · Netherlands

2025-523087-20-00 on CTIS ↗

Phase II Immune System Diseases Authorised 19/05/2026

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ELV001 as Add-on Therapy in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)

Rheumatoid arthritis
Elevara Medicines Limited · 95 participants

📍 Czechia · Bulgaria · Hungary · Netherlands · Poland · Spain

2025-524005-32-00 on CTIS ↗

Phase III Neoplasms Authorised 19/05/2026

Phase III Randomized, International, Open-Label Clinical Trial of Treatment Intensification with Docetaxel plus Apalutamide in Patients with Metastatic Hormone-Sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment with Apalutamide: REINFORCE Trial

Metastatic hormone-sensitive prostate cancer
Alianza Multidisciplinar Para La Investigacion De Los Tumores Genitourinarios Guard · 292 participants

📍 Spain · Germany · France · Portugal · Italy

2025-524408-30-01 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 19/05/2026

A Phase 3 prospective randomised clinical trial of VMX-C001 vs usual pharmacological care in patients receiving a FXa direct oral anticoagulant (FXa DOAC) who require urgent surgery or other invasive procedure that is associated with a high risk of bleeding, with or without planned administration of heparin (EQUILIBRIX-S)

Patients on Factor Xa inhibitor treatment needing an urgent intervention associated with a high risk of bleeding
VarmX B.V. · 443 participants

📍 Belgium · Germany · Italy · France · Czechia · Bulgaria · Hungary · Spain · Netherlands · Poland · Austria · Estonia · Romania · Portugal · Lithuania

2025-521632-12-00 on CTIS ↗

Phase II Nutritional and Metabolic Diseases Authorised 19/05/2026

PODOMOUNT-Basket, a Phase II, multicentre, randomised, 2-arm parallel-group, double-blind, placebo-controlled basket trial to assess safety, tolerability, PK, and efficacy of BI 764198 in four proteinuric kidney diseases

Proteinuric kidney diseases
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 66 participants

📍 Portugal · Greece · Italy · Poland · Estonia · Slovakia · Sweden · Denmark · Belgium · Norway · Romania · France · Spain · Germany · Netherlands · Croatia

2025-523425-17-00 on CTIS ↗

Phase II Neoplasms Authorised 19/05/2026

Beamion 44: A randomized, open-label, multi-center Phase IIa platform trial to evaluate the safety and tolerability of zongertinib plus Pt-doublet with or without pembrolizumab (and potential other combinations) in treatment-naïve patients with locally advanced/metastatic non-squamous NSCLC with activating HER2 mutations

locally advanced or metastatic NSCLC
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 19 participants

📍 Germany · France · Spain

2025-523567-38-00 on CTIS ↗

Phase II Neoplasms Authorised 19/05/2026

A Phase II Study of Naxitamab Added to Induction Therapy for Subjects with Newly Diagnosed High-Risk Neuroblastoma

Neuroblastoma or ganglioneuroblastoma (nodular or intermixed)
Fundacio Sant Joan De Deu · 22 participants

📍 Spain

2025-524140-35-00 on CTIS ↗

Phase II Neoplasms Authorised 19/05/2026

An Open-label, Single-arm, Global Study of Perioperative Durvalumab With Cisplatin-based Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)

Patients With Muscle-Invasive Bladder Cancer
AstraZeneca AB · 60 participants

📍 Italy · Spain · France · Netherlands

2024-519246-75-01 on CTIS ↗

Phase II Neoplasms Authorised 19/05/2026

A Phase II, Open-Label Randomized Study of Intravenous Tambiciclib in Combination with the Standard of care Venetoclax and Azacitidine in Patients with Newly Diagnosed AML Who Failed to Achieve at Least MLFS After the First Two Cycles of Treatment with Venetoclax and Azacitidine Alone

Acute myeloid leukemia
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., IIS La Fe · 40 participants

📍 Italy · Spain

2025-524308-31-00 on CTIS ↗

Phase III Neoplasms Authorised 19/05/2026

A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

Metastatic Microsatellite Stable Colorectal Cancer
Incyte Corp. · 292 participants

📍 Poland · France · Denmark · Norway · Spain · Germany · Belgium · Netherlands · Austria · Italy

2025-523735-19-00 on CTIS ↗

Phase IV Reproductive and Urinary Physiological Phenomena Authorised 18/05/2026

A Multicenter Randomized Controlled Trial Assessing the Efficacy and Safety of Recombinant Human Follicle Stimulating Hormone (r-hFSH-alfa originator) and Human Chorionic Gonadotropin (hCG) in Enhancing Sperm Concentration in Men with Oligozoospermia, Low Testosterone, and Normal FSH Serum Levels (APHRODITE Group 3): A Collaborative Research Initiative

Male Infertility
Martin-Luther-Universitaet Halle-Wittenberg · 138 participants

📍 Italy · Spain · Germany

2025-525005-20-00 on CTIS ↗

Phase II Nutritional and Metabolic Diseases Authorised 18/05/2026

A Phase 2a, Randomized, Open-Label, Active-Controlled, Crossover Study to Evaluate Safety and Explore Efficacy of Different Doses of New Lipase NHS7108 Administered Orally in Participants with Exocrine Pancreatic Insufficiency.

Exocrine Pancreatic Insufficiency
Aimmune Nestle Health Science US R&D LLC · 29 participants

📍 Poland · Hungary · Spain · Bulgaria · Italy

2025-521816-20-00 on CTIS ↗

Phase III Immune System Diseases Authorised 18/05/2026

Prospective, randomised, double-blind, placebo-controlled multicenter clinical trial to evaluate efficacy and safety of immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without mild to moderate asthma, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae and Blomia tropicalis

Aetiological treatment of moderate-to-severe allergic rhinitis/rhinoconjunctivitis with or without mild-to-moderate controlled allergic asthma
Inmunotek S.L. · 120 participants

📍 Spain

2025-522773-12-00 on CTIS ↗

Phase I/II Neoplasms Authorised 18/05/2026

A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination with Nivolumab in Participants with Relapsed/Refractory Small Cell Lung Cancer

Relapsed/Refractory Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company · 21 participants

📍 Italy · Spain · Romania

2025-524090-16-00 on CTIS ↗

Phase II Neoplasms Authorised 18/05/2026

A Phase 2 Study to Evaluate the Safety and Efficacy of Telisotuzumab Adizutecan for the Treatment of Subjects with Locally Advanced or Metastatic Solid Tumors that Harbor MET Amplification

Locally Advanced or Metastatic Solid Tumours that harbour MET Amplification gene
AbbVie Deutschland GmbH & Co. KG · 29 participants

📍 Spain · France · Denmark

2024-518871-74-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 18/05/2026

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS)
Zenas Biopharma (USA) LLC · 398 participants

📍 Italy · Finland · Bulgaria · Greece · Belgium · Estonia · Portugal · Spain · Germany · France · Czechia · Slovakia · Romania · Croatia · Poland · Austria · Netherlands · Denmark · Sweden · Hungary

2025-524316-11-00 on CTIS ↗

Phase II Neoplasms Authorised 18/05/2026

A phase II, multicenter, open-label, single arm study to evaluate the safety and efficacy of asciminib in pediatric participants newly diagnosed or previously treated with Philadelphia positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) with or without known T315I mutation

Philadelphia positive Chronic Myeloid leukemia in Chronic Phase with newly diagnosed and resistant/intolerant to previous TKIs, with or without the T315I mutation
Novartis Pharma AG · 15 participants

📍 Spain · France · Germany · Poland · Italy · Netherlands · Greece

2025-522138-29-00 on CTIS ↗

Phase IV Respiratory Tract Diseases Authorised 18/05/2026

A pragmatic, phase IV, randomized, open-label, multinational, multicentre, 2-arm parallel group, prospective study comparing efficacy and safety of Single Inhaler ICS/LABA/LAMA (beclometasone/formoterol fumarate/glycopyrronium bromide [87/5/9 pMDI {BD/FF/GB - 100/6/12.5 µg}]) vs Single Inhaler ICS/LABA (beclometasone dipropionate plus formoterol fumarate [200/6 pMDI {BD/FF - 200/6 µg}]) in asthma subjects.

Asthma
Chiesi Farmaceutici S.p.A. · 606 participants

📍 Germany · Romania · Italy · Bulgaria · Poland · Slovakia · Spain · France

2025-524289-56-00 on CTIS ↗

Phase III Neoplasms Authorised 18/05/2026

A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody

Relapsed or Refractory Multiple Myeloma
Janssen Cilag International · 157 participants

📍 Spain · Norway · Germany · Greece · France · Italy · Netherlands

2025-522007-18-00 on CTIS ↗

Phase I Neoplasms Authorised 18/05/2026

A Phase I, Open-label, Multi-center, First-in-human Trial to Investigate E303, in Participants with Advanced Refractory Solid Tumors

advanced refractory solid tumors
Samsung Bioepis Co. Ltd. · 40 participants

📍 Spain

2025-524192-24-00 on CTIS ↗

Phase III Neoplasms Authorised 15/05/2026

ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with PD-L1 ≥ 50%

Non-Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company · 265 participants

📍 Portugal · Norway · Sweden · Bulgaria · France · Belgium · Austria · Germany · Finland · Poland · Romania · Netherlands · Spain · Italy · Hungary · Czechia

2025-523586-18-00 on CTIS ↗

Phase I/II Neoplasms Authorised 15/05/2026

A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors, including Checkpoint Inhibitor Naïve Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors

Advanced Solid Tumors
Eikon Therapeutics Inc. · 63 participants

📍 France · Spain · Norway · Italy · Germany · Austria · Poland · Finland · Portugal

2026-525248-13-00 on CTIS ↗

Phase III Immune System Diseases Authorised 14/05/2026

Prospective, randomised, double-blind, placebo-controlled multicenter clinical trial to evaluate efficacy and safety of immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without mild to moderate asthma, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae and Lepidoglyphus destructor.

Aetiological treatment of moderate-to-severe allergic rhinitis/rhinoconjunctivitis with or without mild-to-moderate controlled allergic asthma
Inmunotek S.L. · 120 participants

📍 Spain

2025-522771-28-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 14/05/2026

A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants with Relapsed/Refractory Primary Central Nervous System Lymphoma

Relapsed/refractory primary central nervous system lymphoma
Deciphera Pharmaceuticals Inc. · 74 participants

📍 Czechia · Germany · Italy · Belgium · Spain · Poland · Austria · France

2025-523389-26-00 on CTIS ↗

Phase III Neoplasms Authorised 13/05/2026

A Pivotal Open-label Phase 3 Clinical Study Evaluating the Efficacy and Safety of QTX-2101 in Combination With All-trans Retinoic Acid in Newly Diagnosed, Low-risk Acute Promyelocytic Leukemia

Acute Promyelocytic Leukemia
Quetzal Therapeutics LLC · 89 participants

📍 Germany · Poland · Spain · Romania · Italy · France

2025-524810-28-00 on CTIS ↗