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M23-784

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study title A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects with Moderately to Severely Active Crohn's Disease
Protocol number OCR45063
ClinicalTrials.gov ID NCT06063967
Phase Phase 3

Eligibility

Inclusion Criteria:

  • Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.

  • Participant meets the following disease activity criteria:

    1. Moderate to severe CD as assessed by CDAI

    2. Endoscopic evidence of mucosal inflammation as documented by a SES-CD

  • Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.

Exclusion Criteria:

  • Participants with a current diagnosis of ulcerative colitis or indeterminate colitis.

  • Participants with unstable doses of concomitant Crohn's disease therapy.

  • Participants with prior exposure to p19 inhibitors.

  • Participants with complications of Crohn's disease.

  • Participants having an ostomy or ileoanal pouch.

Lead researcher

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  1. Step
    1

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  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
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