A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Study Identifier
M15-991
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Informed Consent Form
Available Language(s): English
Plain Language Summary
Available Language(s): English, Arabic, Dutch, French, German, Korean
Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Crohn's Disease (CD)
  • Study Drug
  • placebo for risankizumab IV
  • risankizumab SC
  • risankizumab IV
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    16 - 80 Years

    Protocol Summary

    The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.

    Study Locations

    Location
    Status
    Location
    Phoenix VA Health Care System /ID# 162261
    Phoenix, Arizona, United States, 85012
    Status
    Not applicable
    Location
    HonorHealth Research Institute - Shea /ID# 165825
    Scottsdale, Arizona, United States, 85258
    Status
    Not applicable
    Location
    Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211882
    Tempe, Arizona, United States, 85284-2604
    Status
    Not applicable
    Location
    University of Arizona /ID# 158305
    Tucson, Arizona, United States, 85724
    Status
    Not applicable
    Location
    Duplicate_Atria Clinical Research /ID# 164504
    Little Rock, Arkansas, United States, 72209-7040
    Status
    Not applicable
    Location
    Southern California Res. Ctr. /ID# 211989
    Coronado, California, United States, 92118-1408
    Status
    Not applicable
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