[M23-784] A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

JRCT ID: jRCT2061230105

Registered date:11/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Crohn's Disease
• Date of first enrollment: 01/05/2024
• Target sample size: 276
• Countries of recruitment: United States,Japan,Canada,Japan,Israel,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

Period A: Risankizumab Dose A or Pracebo
Participants randomized to receive risankizumab Dose A or placebo risankizumab administered by subcutaneous (SC) injection for up to 12 weeks during Period A.

Period B: Risankizumab Dose B or Pracebo or Risankizumab Dose C
Participants randomized to receive risankizumab Dose A in Period A that achieved adequate response to receive risankizumab Dose B administered by subcutaneous (SC) injection for up to 20 weeks.
Participants randomized to receive placebo risankizumab in Period A that achieved adequate response to continue to receive placebo risankizumab administered by Subcutaneous (SC) injection for up to 20 weeks in Period B.
Participants with inadequate response in Period A to receive Dose C administered by Subcutaneous (SC) injection for up to 20 weeks during Period B.

Outcome(s)

Primary Outcome

- Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150) (Time Frame: Week 12)
- Percentage of Participants With Endoscopic Response (Time Frame: Week 12)

Secondary Outcome

- Percentage of Participants With SF / APS Clinical Remission (Time Frame: Week 12)
- Percentage of Participants With Endoscopic Remission (Time Frame: Week 12)
- Percentage of Participants With Ulcer-Free Endoscopy (Time Frame: Week 12)
- Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (Time Frame: Week 12)
- Percentage of Participants with a CR-100 Clinical Response (Time Frame: Week 4)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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
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.

Exclude 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.

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT06063967