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Clinical trials for Crohn's Disease AND Placebo Comparator

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   44334   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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    11 result(s) found for: Crohn's Disease AND Placebo Comparator. Displaying page 1 of 1.
    EudraCT Number: 2021-003314-39 Sponsor Protocol Number: 78934804CRD2001 Start Date*: 2023-02-21
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Gusel...
    Medical condition: Moderately to Severely Active Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) HU (Trial now transitioned) FR (Trial now transitioned) NL (Trial now transitioned) CZ (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) AT (Ongoing) PT (Trial now transitioned) BG (Trial now transitioned) IE (Completed) NO (Trial now transitioned) SI (Trial now transitioned) SE (Trial now transitioned) DK (Trial now transitioned) GR (Trial now transitioned) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-001148-22 Sponsor Protocol Number: CRAD001F2201 Start Date*: 2005-06-27
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease
    Medical condition: Crohn's disease
    Disease: Version SOC Term Classification Code Term Level
    7.1 10011401 Low
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed)
    Trial results: View results
    EudraCT Number: 2004-002815-10 Sponsor Protocol Number: C0168T67 Start Date*: 2005-05-04
    Sponsor Name:Centocor B.V.
    Full Title: Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Nai...
    Medical condition: moderate to severe Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    7.1 10011401
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SE (Completed) DE (Completed) GB (Completed) ES (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2016-000678-40 Sponsor Protocol Number: Vedolizumab-4013 Start Date*: 2016-08-19
    Sponsor Name:Takeda Development Centre Europe Limited
    Full Title: Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease
    Medical condition: Ulcerative Colitis and Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    20.0 100000004856 10013099 Disease Crohns LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) CZ (Completed) HU (Completed) EE (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-000634-21 Sponsor Protocol Number: 64304500CRD2001 Start Date*: 2016-11-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Cro...
    Medical condition: Active 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: DE (Completed) GB (GB - no longer in EU/EEA) HU (Completed) PL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002195-13 Sponsor Protocol Number: CNTO1959CRD3001 Start Date*: 2019-06-05
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Seve...
    Medical condition: Moderately to Severely Active 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: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) BE (Trial now transitioned) AT (Completed) FR (Trial now transitioned) LT (Completed) CZ (Trial now transitioned) SK (Trial now transitioned) NL (Trial now transitioned) LV (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) GR (Completed) PT (Trial now transitioned) HR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-003827-38 Sponsor Protocol Number: CL004_282 Start Date*: 2006-05-02
    Sponsor Name:ChemoCentryx, Inc
    Full Title: A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease
    Medical condition: Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DK (Completed) CZ (Completed) DE (Completed) HU (Completed) BG (Completed) SE (Completed) FR (Completed) BE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004614-18 Sponsor Protocol Number: I6T-MC-AMAM Start Date*: 2019-07-10
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Acti...
    Medical condition: moderately to severely active 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: AT (Completed) HU (Completed) FR (Completed) GB (GB - no longer in EU/EEA) DE (Completed) NL (Completed) ES (Completed) PL (Completed) DK (Completed) BE (Completed) SK (Completed) LT (Completed) CZ (Completed) LV (Completed) HR (Completed) IT (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2018-004346-42 Sponsor Protocol Number: 3150-301-008 Start Date*: 2019-09-10
    Sponsor Name:AstraZeneca AB
    Full Title: A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikuma...
    Medical condition: Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10011402 Crohn's disease (colon) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) FR (Completed) ES (Prematurely Ended) BG (Prematurely Ended) AT (Prematurely Ended) CZ (Prematurely Ended) HU (Prematurely Ended) BE (Not Authorised) IT (Prematurely Ended) SK (Prematurely Ended) RO (Completed)
    Trial results: View results
    EudraCT Number: 2016-002210-46 Sponsor Protocol Number: LiSA Start Date*: 2016-07-28
    Sponsor Name:University Medical Centre RadboudUMC
    Full Title: Study: Reduces intravenous lidocaine the need for alfentanyl during colonoscopy under Procedural Sedation and Analgesia?
    Medical condition: patients with IBD, between 18 and 65 years, which are scheduled for a colonoscopy with PSA.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2006-003607-40 Sponsor Protocol Number: GETAID 2006-1 Start Date*: 2008-11-13
    Sponsor Name:Besancon University Hospital
    Full Title: A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS
    Medical condition: Steroid-dependent ulcerative colitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Completed) AT (Ongoing) FI (Completed)
    Trial results: (No results available)
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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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