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Clinical trials for Biologic agent

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   44335   clinical trials with a EudraCT protocol, of which   7366   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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    120 result(s) found for: Biologic agent. Displaying page 1 of 6.
    1  2  3  4  5  6  Next»
    EudraCT Number: 2013-000054-22 Sponsor Protocol Number: ML28641 Start Date*: 2013-10-01
    Sponsor Name:Roche Products Limited
    Full Title: OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOI...
    Medical condition: Rheumatoid Arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-001742-16 Sponsor Protocol Number: C0524T11 Start Date*: 2006-05-26
    Sponsor Name:Centocor B.V.
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthri...
    Medical condition: Active rheumatoid arthritis (RA)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) DE (Completed) AT (Completed) FI (Completed) ES (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: 2019-004108-37 Sponsor Protocol Number: CC-99677-AS-001 Start Date*: 2021-07-09
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects with Active Ankylosing Spondylitis
    Medical condition: Ankylosing Spondylitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10002556 Ankylosing spondylitis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Prematurely Ended) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2016-001163-37 Sponsor Protocol Number: CNTO1959PSA3001 Start Date*: 2017-07-25
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects with Active Psoriatic Arthritis i...
    Medical condition: Active Psoriatic Arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) ES (Completed) DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-001224-63 Sponsor Protocol Number: CNTO1959PSA3002 Start Date*: 2017-07-06
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects with Active Psoriatic Arthritis
    Medical condition: Active Psoriatic Arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) CZ (Completed) EE (Completed) PL (Completed) LT (Completed) LV (Completed) BG (Completed) PT (Completed) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004300-65 Sponsor Protocol Number: AGO/2016/012 Start Date*: 2017-09-26
    Sponsor Name:Ghent University Hospital
    Full Title: Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFα) blocking Agent by immunoscintigraphy with Technetium-labeled C...
    Medical condition: rheumatoid arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-001367-36 Sponsor Protocol Number: GS-US-419-3895 Start Date*: 2017-02-08
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to ...
    Medical condition: Moderately to Severely Active Crohn’s Disease (CD)
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004856 10013099 Disease Crohns LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed) AT (Completed) CZ (Completed) GB (GB - no longer in EU/EEA) IS (Completed) SE (Completed) DE (Completed) GR (Completed) PT (Completed) SK (Completed) ES (Completed) BE (Completed) NL (Completed) HR (Completed) NO (Completed) IT (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
    EudraCT Number: 2016-001833-29 Sponsor Protocol Number: 202152 Start Date*: 2016-09-07
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and...
    Medical condition: Active ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10017969 Gastrointestinal inflammatory conditions HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) PL (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-012265-60 Sponsor Protocol Number: CNTO1275PSA3002 Start Date*: 2010-03-22
    Sponsor Name:Janssen Biologics B.V.
    Full Title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ps...
    Medical condition: Psoriatric arthritis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) SE (Completed) FR (Completed) GB (Completed) PL (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2013-004122-28 Sponsor Protocol Number: RR13/10782 Start Date*: 2015-03-02
    Sponsor Name:The Leeds Teaching Hospitals NHS Trust
    Full Title: An investigator‐initiated double‐blind, parallel‐group randomised controlled trial of GOLimumab and Methotrexate versus Methotrexate in very early PsA using clinical and whole body MRI outcomes: th...
    Medical condition: Adult patients with a diagnosis of Psoriatic Arthritis(PsA), (Caspar criteria) of less than 24-month duration.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-005390-36 Sponsor Protocol Number: UoL001109 Start Date*: 2016-02-17
    Sponsor Name:The University of Liverpool
    Full Title: Optimal utilisation of biologic drugs in Behçet’s Disease: a randomised controlled trial of infliximab (IFX) verses alpha interferon (aIFN), with genotyping and metabolomic profiling, towards a str...
    Medical condition: Behcets Disease
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004866 10004212 Behcet's disease LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2010-022243-38 Sponsor Protocol Number: CNTO136ARA3003 Start Date*: 2012-07-11
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Activ...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) DE (Completed) GB (Completed) AT (Completed) ES (Completed) PT (Completed) BE (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-004241-16 Sponsor Protocol Number: B7931030 Start Date*: 2019-08-02
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF PF-06700841 TO EVALUATE THE EFFICACY AT 16 WEEKS AND TO EVALUATE THE SAFETY AND EFFICACY UP TO 1 YEAR IN SUBJECTS WITH ACTIVE PSORI...
    Medical condition: Psoriatic arthritis (PsA)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) HU (Completed) CZ (Completed) BG (Completed) LT (Completed) EE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-001332-11 Sponsor Protocol Number: IRELANDPILOTV1 Start Date*: 2014-07-30
    Sponsor Name:Royal College of Surgeons
    Full Title: Aspirin for Optimising Pregnancy Outcome in Pregestational Diabetes: Pilot for The IRELAND Study (Investigating the Role of Early Low-dose Aspirin iN preexisting Diabetes)
    Medical condition: Pregestational diabetes represents a high-risk for evolution of preeclampsia (PET), with rates of PET within this group at approximately 20%. The combination of diabetes and preeclampsia places the...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2016-001392-78 Sponsor Protocol Number: GS-US-418-3898 Start Date*: 2017-01-30
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately ...
    Medical condition: Moderately to Severely Active Ulcerative Colitis (UC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000016670 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) GB (Completed) BE (Completed) SE (Completed) AT (Completed) PT (Completed) GR (Completed) SK (Completed) IS (Completed) ES (Completed) BG (Completed) DE (Completed) NL (Completed) HR (Completed) NO (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-000312-15 Sponsor Protocol Number: P150902 Start Date*: 2016-08-12
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Treatment tapering in oligoarticular or rheumatoid factor negative polyarticular Juvenile Idiopathic Arthritis with inactive disease on biologic therapy
    Medical condition: Patients with oligoarticular onset or rheumatoid factor negative polyarticular JIA followed in tertiary care center for paediatric rheumatology.
    Disease: Version SOC Term Classification Code Term Level
    19.0 10028395 - Musculoskeletal and connective tissue disorders 10059176 Juvenile idiopathic arthritis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-003162-13 Sponsor Protocol Number: WI232128 Start Date*: 2019-01-23
    Sponsor Name:AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
    Full Title: A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib
    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: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005330-20 Sponsor Protocol Number: WA20495 Start Date*: 2007-06-07
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an in...
    Medical condition: Rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10028395 Musculoskeletal and connective tissue disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) FR (Completed) HU (Completed) ES (Temporarily Halted) CZ (Completed) NL (Completed) SI (Completed) SE (Completed) IT (Completed) SK (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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