NCT06063967

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

Brief 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 and a Period B. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC 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. 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. The duration of the study will be approximately 49 weeks.

Interventional

Interventional study

Status:
Recruiting
Conditions:
Crohn's Disease
Enrollment:
276 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M23-784
Allocation:
Randomized
Intervention model:
Sequential Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

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 COAi

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.

All the cities where the clinical studies are located

Vaughan - L4L 4Y7

Ontario

Vaughan

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More information about this study

clinicaltrials.gov