A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Study Identifier
M16-067
CT.gov Identifier
NCT03398148
EudraCT Identifier
2016-004677-40
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
Available Language(s): English, English, Dutch, Italian, Japanese, Japanese, Polish, Turkish, Ukrainian
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Scientific Result Summary
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
  • risankizumab IV
  • placebo for risankizumab
  • risankizumab SC
    • Phase
    Phase 2/Phase 3
    Sex
    Female & Male
    Age
    16 - 80 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Male or female aged \>=18 to \<= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to \< 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit. * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline. * Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore. * Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies. * Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.
    Exclusion Criteria:
    * Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis. * Participant receiving prohibited medications and treatment. * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy. * Participant with currently known complications of UC (e.g., megacolon). * No known active Coronavirus Disease - 2019 (COVID-19) infection.

    Protocol Summary

    The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.

    The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

    Study Locations

    Location
    Status
    Location
    Southern California Res. Ctr. /ID# 169660
    Coronado, California, United States, 92118-1408
    Status
    Not applicable
    Location
    Hoag Memorial Hosp Presbyterian /ID# 218348
    Irvine, California, United States, 92618
    Status
    Not applicable
    Location
    UC San Diego Health System /ID# 160452
    La Jolla, California, United States, 92037
    Status
    Not applicable
    Location
    United Medical Doctors /ID# 158528
    Los Alamitos, California, United States, 90720-3309
    Status
    Not applicable
    Location
    Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200931
    Los Angeles, California, United States, 90067-2001
    Status
    Not applicable
    Location
    UCSF Center for Colitis and Crohn's Disease /ID# 201210
    San Francisco, California, United States, 94115-3011
    Status
    Not applicable
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