interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development
EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).
The EU Clinical Trials Register currently displays
44346
clinical trials with a EudraCT protocol, of which
7374
are clinical trials conducted with subjects less than 18 years old.
The register also displays information on
18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see
Frequently Asked Questions ).
Full Title: A multicenter, single-arm, open-label trial to evaluate efficacy and safety of oral, twice daily iptacopan in adult PNH patients who are naive to complement inhibitor therapy
Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
Full Title: A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF RO7198457 IN COMBINATION WITH PEMBROLIZUMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED M...
Medical condition: Advanced melanoma
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10066600
Melanoma recurrent
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10027481
Metastatic melanoma
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10025671
Malignant melanoma stage IV
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10025650
Malignant melanoma
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10025670
Malignant melanoma stage III
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:GB(GB - no longer in EU/EEA)DE(Trial now transitioned)BE(Completed)
Trial results:(No results available)
EudraCT Number: 2017-002704-27
Sponsor Protocol Number: VBP15-004-A4
Start Date*: 2019-07-06
Sponsor Name:ReveraGen BioPharma, Inc.
Full Title: A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne...
Medical condition: Duchenne muscular dystrophy (DMD)
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10010331 - Congenital, familial and genetic disorders
10013801
Duchenne muscular dystrophy
PT
Population Age: Children, Under 18
Gender: Male
Trial protocol:BE(Completed)SE(Completed)NL(Completed)CZ(Completed)GR(Completed)ES(Completed)GB(GB - no longer in EU/EEA)
Full Title: REVEAL 2: A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation with CELLECTRA™ 5PSP for the Treatment of HPV-1...
Medical condition: HPV-16 and/or HPV-18 related high grade squamous intraepithelial lesion (HSIL) of the cervix
Disease:
Version
SOC Term
Classification Code
Term
Level
20.1
10022891 - Investigations
10064328
Human papilloma virus test positive
PT
20.0
100000004872
10066237
Cervical high grade squamous intraepithelial lesion
LLT
Population Age: Adults, Elderly
Gender: Female
Trial protocol:GB(GB - no longer in EU/EEA)LT(Completed)EE(Completed)ES(Restarted)PL(Completed)FI(Completed)IT(Completed)
Sponsor Name:Bristol-Myers Squibb International Corporation
Full Title: An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis
Medical condition: Moderate-to-Severe Plaque Psoriasis
Disease:
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:HU(Trial now transitioned)PL(Trial now transitioned)GB(GB - no longer in EU/EEA)CZ(Trial now transitioned)SE(Trial now transitioned)ES(Ongoing)DE(Ongoing)FI(Trial now transitioned)FR(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2021-006326-48
Sponsor Protocol Number: CO43810
Start Date*: 2022-09-27
Sponsor Name:Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
Full Title: A PHASE I/II, OPEN-LABEL, SINGLE-ARM, TWO-PART TRIAL TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI-TUMOR ACTIVITY OF GLOFITAMAB IN COMBINATION WITH CHEMOIMMUNOTHERAPY IN PEDIATRIC AN...
Medical condition: CD20 positive B-Cell Non-Hodgkin Lymphoma
Disease:
Version
SOC Term
Classification Code
Term
Level
23.1
100000004864
10084346
B-cell non-Hodgkin's lymphoma
LLT
Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults
Gender: Male, Female
Trial protocol:ES(Ongoing)DK(Trial now transitioned)IT(Trial now transitioned)DE(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2018-002301-61
Sponsor Protocol Number: 2215-CL-0603
Start Date*: 2020-01-14
Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
Full Title: A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation
and Expansion Study of Gilteritinib (ASP2215) Combined with
Chemotherapy in Children, Adolescents and Young Adults with FMS-like
Ty...
Medical condition: FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or
Refractory Acute Myeloid Leukemia (AML)
Disease:
Version
SOC Term
Classification Code
Term
Level
21.0
100000004864
10000886
Acute myeloid leukemia
LLT
Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults
Gender: Male, Female
Trial protocol:GB(GB - no longer in EU/EEA)DE(Trial now transitioned)ES(Ongoing)IT(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2018-002261-19
Sponsor Protocol Number: PRN1008-012
Start Date*: 2018-12-12
Sponsor Name:Principia Biopharma
Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus
Medical condition: pemphigus vulgaris [PV] or pemphigus foliaceus [PF]
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
100000004858
10052802
Pemphigus vulgaris
LLT
21.0
100000004858
10057054
Pemphigus foliaceous
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:BG(Prematurely Ended)FR(Prematurely Ended)DE(Prematurely Ended)GB(GB - no longer in EU/EEA)ES(Ongoing)GR(Completed)HR(Completed)IT(Prematurely Ended)
Full Title: Ensayo abierto, aleatorizado, de dos años de duración, en el que se comparan dos regímenes de primera línea en sujetos infectados por el VIH que no han recibido tratamiento antirretroviral previo: ...
Medical condition: Infección por el virus de la inmunodeficiencia humana
Full Title: Phase I/IIa, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BNT141 as a monotherapy and...
Medical condition: CLDN18.2-positive solid tumors
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10065252
Solid tumor
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10017758
Gastric cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10066354
Adenocarcinoma of the gastroesophageal junction
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10015332
Esophageal adenocarcinoma recurrent
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10033604
Pancreatic cancer
LLT
20.0
100000004871
10004676
Biliary tract disease
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10008593
Cholangiocarcinoma
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: A Randomized, Double-Blind, Phase III Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cance...
Medical condition: metastatic squamous NSCLC
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10023775
Large cell lung cancer recurrent
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10001245
Adenosquamous cell lung cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10001247
Adenosquamous cell lung cancer recurrent
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10061873
Non-small cell lung cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis
Medical condition: Relapsing remitting multiple sclerosis (RRMS)
Disease:
Version
SOC Term
Classification Code
Term
Level
20.1
10029205 - Nervous system disorders
10028245
Multiple sclerosis
PT
21.1
10029205 - Nervous system disorders
10063399
Relapsing-remitting multiple sclerosis
PT
20.0
10029205 - Nervous system disorders
10048393
Multiple sclerosis relapse
PT
20.1
10029205 - Nervous system disorders
10039720
Sclerosis multiple
LLT
Population Age: Adults
Gender: Male, Female
Trial protocol:NO(Completed)SE(Completed)AT(Completed)DK(Completed)DE(Completed)PT(Completed)BE(Completed)HU(Completed)PL(Completed)SK(Completed)ES(Ongoing)BG(Completed)SI(Completed)NL(Completed)GB(GB - no longer in EU/EEA)FR(Ongoing)HR(Completed)IT(Completed)
Full Title: Phase 1/2a, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T with or without CLDN6 RNA-LPX in patients with CLDN6-...
Medical condition: CLDN6-positive relapsed or refractory advanced solid tumors
Disease:
Version
SOC Term
Classification Code
Term
Level
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10043302
Testicular cancer
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10033128
Ovarian cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10017758
Gastric cancer
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10046766
Uterine cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10061873
Non-small cell lung cancer
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10007460
Carcinoma of unknown primary
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10065147
Malignant solid tumor
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:DE(Trial now transitioned)NL(Trial now transitioned)SE(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2018-003974-29
Sponsor Protocol Number: D6186C00001
Start Date*: 2019-08-15
Sponsor Name:AstraZeneca AB
Full Title: A Biomarker-Directed Phase 2 Platform Study in Patients with Advanced Non-Small Cell Lung Cancer whose Disease has Progressed on First-Line Osimertinib Therapy
Medical condition: Advanced Non-Small Cell Lung Cancer
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10061873
Non-small cell lung cancer
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:SE(Trial now transitioned)NO(Trial now transitioned)DK(Completed)ES(Ongoing)NL(Trial now transitioned)IT(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2020-003767-25
Sponsor Protocol Number: APL2-C3G-310
Start Date*: 2022-03-08
Sponsor Name:Apellis Pharmaceuticals, Inc.
Full Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoprolif...
Medical condition: complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10038359 - Renal and urinary disorders
10038359
Renal and urinary disorders
SOC
20.0
10038359 - Renal and urinary disorders
10077827
C3 glomerulopathy
PT
21.1
10038359 - Renal and urinary disorders
10027168
Membranoproliferative glomerulonephritis
LLT
Population Age: Adolescents, Under 18, Adults, Elderly
Gender: Male, Female
Trial protocol:DE(Trial now transitioned)NL(Trial now transitioned)CZ(Completed)BE(Completed)AT(Trial now transitioned)FR(Completed)PL(Completed)IT(Trial now transitioned)ES(Ongoing)
Trial results:(No results available)
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