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Clinical trials for Biosimilars

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • 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   44338   clinical trials with a EudraCT protocol, of which   7368   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    36 result(s) found for: Biosimilars. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2013-003893-29 Sponsor Protocol Number: BAY80-6946/17067 Start Date*: 2015-06-25
    Sponsor Name:Bayer AG
    Full Title: A Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of copanlisib in combination with rituximab in patients with relapsed indolent B-cell non-Hodgkin’...
    Medical condition: Patients with relapsed indolent B-cell non-Hodgkin's lymphoma
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029600 Non-Hodgkin's lymphoma recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) PT (Completed) DE (Prematurely Ended) ES (Prematurely Ended) BE (Completed) LT (Completed) HU (Prematurely Ended) AT (Prematurely Ended) DK (Prematurely Ended) FR (Prematurely Ended) BG (Prematurely Ended) LU (Completed) GR (Completed) SK (Prematurely Ended) IT (Prematurely Ended) RO (Completed)
    Trial results: View results
    EudraCT Number: 2015-001088-38 Sponsor Protocol Number: BAY80-6946/17833 Start Date*: 2015-12-09
    Sponsor Name:Bayer AG
    Full Title: A Phase III, randomized, double-blind, controlled, multicenter study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in p...
    Medical condition: Patients with relapsed indolent non-Hodgkin's lymphoma
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029600 Non-Hodgkin's lymphoma recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended) DE (Prematurely Ended) BE (Completed) CZ (Completed) DK (Prematurely Ended) ES (Prematurely Ended) GB (Completed) FR (Completed) PL (Prematurely Ended) IE (Prematurely Ended) AT (Prematurely Ended) PT (Prematurely Ended) HU (Completed) SK (Prematurely Ended) GR (Completed) BG (Prematurely Ended) IT (Prematurely Ended) RO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001546-33 Sponsor Protocol Number: RHMMED1526 Start Date*: 2018-07-11
    Sponsor Name:University Southampton Hospital NHS Foundation Trust
    Full Title: IBD Biosimilar to Biosimilar Infliximab Switching Study
    Medical condition: Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10021972 Inflammatory bowel disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002681-39 Sponsor Protocol Number: PHI113747 Start Date*: 2013-12-20
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: A 24-week, Phase 2B, randomized, active-controlled, parallel group, multi-center study to evaluate the safety and efficacy of GSK1278863 in subjects with anemia associated with chronic kidney disea...
    Medical condition: Anemia associated with chronic kidney disease.
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004857 10064848 Chronic kidney disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) SE (Completed) GB (Completed) CZ (Completed) HU (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-003090-34 Sponsor Protocol Number: 1368-0008 Start Date*: 2019-02-05
    Sponsor Name:Boehringer Ingelheim RCV GmbH & Co KG
    Full Title: Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease
    Medical condition: Fistulizing Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10075465 Fistulizing Crohn's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) BE (Completed) DE (Completed) NL (Prematurely Ended) HU (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003214-41 Sponsor Protocol Number: CNTO1959PSA3003 Start Date*: 2019-01-22
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants with Active Psoriatic Arthrit...
    Medical condition: Psoriatic Arthritis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) GB (Completed) ES (Completed) PL (Completed) PT (Completed) HU (Completed) BG (Completed) GR (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-003986-33 Sponsor Protocol Number: APD334-302 Start Date*: 2019-07-01
    Sponsor Name:Arena Pharmaceuticals Inc.
    Full Title: A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    20.1 100000004856 10045366 Ulcerative colitis, unspecified LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) BE (Completed) NL (Completed) GB (GB - no longer in EU/EEA) EE (Completed) DE (Completed) AT (Completed) CZ (Completed) FR (Completed) DK (Completed) LT (Completed) BG (Completed) PT (Completed) LV (Prematurely Ended) HU (Completed) PL (Completed) HR (Completed) ES (Ongoing) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2020-004775-40 Sponsor Protocol Number: APD334-202EU Start Date*: 2021-05-11
    Sponsor Name:Arena Pharmaceuticals Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease
    Medical condition: Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) DK (Trial now transitioned) SK (Trial now transitioned) LT (Completed) LV (Completed) HU (Trial now transitioned) CZ (Trial now transitioned) PT (Prematurely Ended) NO (Completed) BE (Trial now transitioned) BG (Trial now transitioned) ES (Ongoing) HR (Trial now transitioned) IT (Trial now transitioned) RO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002895-14 Sponsor Protocol Number: APD334-202 Start Date*: 2020-02-13
    Sponsor Name:Arena Pharmaceuticals Inc.
    Full Title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to S...
    Medical condition: Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) NO (Completed) GB (Prematurely Ended) GR (Prematurely Ended) PT (Prematurely Ended) FR (Completed) CZ (Prematurely Ended) SK (Prematurely Ended) NL (Completed) BG (Prematurely Ended) HU (Prematurely Ended) ES (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-000695-19 Sponsor Protocol Number: SB5-4001 Start Date*: 2022-07-22
    Sponsor Name:Samsung Bioepis Co., Ltd
    Full Title: A Phase IV, Randomised, Double-blind, Parallel-group, Multiple-dose, Active Comparator, Multicentre Clinical Study to Evaluate the Pharmacokonetics, Efficacy, Safety, and Immunogenicity of SB5 Vers...
    Medical condition: Moderate to severe plaque psioriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) CZ (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004790-32 Sponsor Protocol Number: 204836 Start Date*: 2016-03-07
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A 29-day, randomized, double-blinded, placebo-controlled, parallel-group, multi-center study to evaluate the efficacy, safety and pharmacokinetics of three-times weekly dosing of GSK1278863 in hemo...
    Medical condition: Anemia associated with chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004851 10002272 Anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-004050-29 Sponsor Protocol Number: PHI116581 Start Date*: 2013-01-07
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A four-week Phase IIa, randomized, double-blind, placebocontrolled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in subjects with anemia as...
    Medical condition: Anemia associated with chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004857 10064848 Chronic kidney disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-002908-15 Sponsor Protocol Number: RR-152-REDO Start Date*: 2016-11-08
    Sponsor Name:Sint Maartenskliniek
    Full Title: REDO study: RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization
    Medical condition: Rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    19.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2016-002126-36 Sponsor Protocol Number: BP39261 Start Date*: 2017-03-01
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A randomized, double-blind, placebo-controlled, multi-center, three-part phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-003955-14 Sponsor Protocol Number: AMT-101-204 Start Date*: 2020-12-21
    Sponsor Name:Applied Molecular Transport Inc.
    Full Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Adults with Active Rheumatoid Arthritis who have demonstrated...
    Medical condition: Active Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    23.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-002569-16 Sponsor Protocol Number: I8H-MC-BDCU Start Date*: 2022-05-20
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared with Insulin Degludec in Participants with Type 2 Diabetes Currently ...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) HU (Completed) ES (Ongoing) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-001430-33 Sponsor Protocol Number: GS-US-365-4237 Start Date*: 2020-05-15
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis
    Medical condition:
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) FR (Completed) GB (GB - no longer in EU/EEA) DE (Completed) PL (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-004209-41 Sponsor Protocol Number: CNTO1275CRD3007 Start Date*: 2018-06-21
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Modera...
    Medical condition: Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) CZ (Completed) FR (Completed) PL (Completed) DE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) BG (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-004278-88 Sponsor Protocol Number: GA28950 Start Date*: 2014-06-19
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLIT...
    Medical condition: Ulcerative colitis (UC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) GR (Completed) DE (Completed) CZ (Completed) DK (Completed) BE (Completed) HU (Completed) AT (Completed) ES (Completed) NL (Completed) IT (Completed) FR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-005606-38 Sponsor Protocol Number: CNTO1275UCO3001 Start Date*: 2015-10-07
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with M...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) AT (Completed) CZ (Completed) DK (Completed) NL (Completed) SK (Completed) BE (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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