A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

Study Identifier
M23-784
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2024-516023-13-00
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Study Details

Medical Condition
  • Crohn's Disease (CD)
  • Study Drug
  • Risankizumab SC
  • Placebo for risankizumab
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants.

    Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally.

    Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.

    Study Locations

    Location
    Status
    Location
    Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178
    Sun City, Arizona, United States, 85351
    Status
    Not applicable
    Location
    Kindred Medical Institute - Corona /ID# 262075
    Corona, California, United States, 92879-3104
    Status
    Not applicable
    Location
    Southern California Res. Ctr. /ID# 256612
    Coronado, California, United States, 92118-1408
    Status
    Not applicable
    Location
    Valley Clinical Trials, LLC dba Flourish Research /ID# 256610
    Covina, California, United States, 91723
    Status
    Not applicable
    Location
    Newport Huntington Medical Group /ID# 256622
    Huntington Beach, California, United States, 92648-5994
    Status
    Not applicable
    Location
    Om Research LLC /ID# 259645
    Lancaster, California, United States, 93534
    Status
    Not applicable
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