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Clinical trials for Etrolizumab

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   44347   clinical trials with a EudraCT protocol, of which   7375   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: Etrolizumab. Displaying page 1 of 1.
    EudraCT Number: 2014-003824-36 Sponsor Protocol Number: GA29144 Start Date*: 2015-08-12
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATE...
    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: SE (Completed) EE (Completed) LT (Completed) LV (Completed) HU (Completed) DE (Prematurely Ended) ES (Ongoing) CZ (Completed) NL (Completed) AT (Completed) SK (Completed) BE (Completed) FR (Completed) HR (Completed) RO (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003855-76 Sponsor Protocol Number: GA29145 Start Date*: 2015-08-12
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144
    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: SE (Prematurely Ended) EE (Prematurely Ended) LT (Prematurely Ended) LV (Prematurely Ended) HU (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) NL (Prematurely Ended) SK (Prematurely Ended) CZ (Prematurely Ended) BE (Prematurely Ended) AT (Completed) FR (Ongoing) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-004435-72 Sponsor Protocol Number: GA28951 Start Date*: 2014-10-24
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES
    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: GB (GB - no longer in EU/EEA) SE (Prematurely Ended) DE (Prematurely Ended) CZ (Prematurely Ended) DK (Prematurely Ended) LV (Prematurely Ended) LT (Prematurely Ended) AT (Completed) PT (Prematurely Ended) EE (Prematurely Ended) NL (Prematurely Ended) NO (Prematurely Ended) ES (Prematurely Ended) GR (Prematurely Ended) BE (Prematurely Ended) HR (Completed) IT (Prematurely Ended) SK (Prematurely Ended) HU (Prematurely Ended) BG (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2013-004279-11 Sponsor Protocol Number: GA28948 Start Date*: 2014-10-03
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLAC...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) BG (Completed) SK (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-004277-27 Sponsor Protocol Number: GA28949 Start Date*: 2014-07-28
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLAC...
    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: LV (Completed) LT (Completed) HR (Completed) BG (Completed) GR (Completed) HU (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-004282-14 Sponsor Protocol Number: GA29103 Start Date*: 2014-09-29
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE...
    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: GB (Completed) DE (Completed) CZ (Completed) AT (Completed) PT (Completed) NL (Completed) NO (Completed) ES (Completed) BE (Completed) IT (Completed) HU (Completed) FR (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: 2013-004280-31 Sponsor Protocol Number: GA29102 Start Date*: 2014-10-07
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODER...
    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: CZ (Completed) DK (Completed) DE (Completed) HU (Completed) SK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-003649-10 Sponsor Protocol Number: CA40192 Start Date*: 2018-03-13
    Sponsor Name:Roche Farma S.A. (Soc unipersonal) que realiza el ensayo en España y que actúa como represntante de FHoffmann-La Roche
    Full Title: A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LES...
    Medical condition: Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    20.0 10017947 - Gastrointestinal disorders 10009900 Colitis ulcerative PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) GB (GB - no longer in EU/EEA) PL (Prematurely Ended) DE (Completed) BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004652-11 Sponsor Protocol Number: MA41419 Start Date*: 2020-08-28
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: RANDOMIZED, OPEN-LABEL PHASE 3B STUDY OF ETROLIZUMAB BASED INDUCTION THERAPY COMBINATIONS FOLLOWED BY ETROLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS
    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: SI (Completed)
    Trial results: View results
    EudraCT Number: 2011-003409-36 Sponsor Protocol Number: GA27927 Start Date*: 2011-11-14
    Sponsor Name:Genentech, Inc.
    Full Title: A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis
    Medical condition: Ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) CZ (Completed) ES (Completed) GB (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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