CTIS2023-504737-41-00
Active, not recruiting
Phase 1
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease - CNTO1959CRD3004
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Moderately to Severely Active Crohn's Disease
- Sponsor
- Janssen - Cilag International
- Enrollment
- 510
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinically active Crohn's disease or fistulizing Crohn's disease of at least 3 months duration, Endoscopic evidence of active ileocolonic Crohn's disease, Current treatment with oral corticosteroids and/or immunomodulators, OR history of failure to respond to or tolerate oral corticosteroids and/or immunomodulators, OR history of corticosteroid dependence, OR has previously demonstrated lack of initial response, lost response or were intolerant to 1 or more biologic agents.
Exclusion Criteria
- •Has a draining stoma or ostomy., Presence on screening endoscopy or history of adenomatous colonic polyps that were not removed., Has previously received a biologic agent targeting IL\-12/23 or IL\-23\.
Outcomes
Primary Outcomes
Not specified
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