A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Study Identifier
M16-066
CT.gov Identifier
NCT03398135
EudraCT Identifier
Not available
EUCTIS ID
2023-506994-36-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
  • risankizumab
  • placebo for risankizumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    16 - 80 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.
    Exclusion Criteria:
    * Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study. * Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. * Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.

    Protocol Summary

    The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

    This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.

    Study Locations

    Location
    Status
    Location
    Southern California Res. Ctr. /ID# 169659
    Coronado, California, United States, 92118-1408
    Status
    Not applicable
    Location
    Hoag Memorial Hosp Presbyterian /ID# 218347
    Irvine, California, United States, 92618
    Status
    Not applicable
    Location
    UC San Diego Health System /ID# 160430
    La Jolla, California, United States, 92037
    Status
    Not applicable
    Location
    United Medical Doctors /ID# 158574
    Los Alamitos, California, United States, 90720-3309
    Status
    Not applicable
    Location
    Cedars-Sinai Medical Center /ID# 163848
    Los Angeles, California, United States, 90048
    Status
    Not applicable
    Location
    Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200934
    Los Angeles, California, United States, 90067-2001
    Status
    Not applicable
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