A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

• Status: Recruiting
• Trial end date: 2026-02-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Diagnosis of Crohn's disease (CD) of at least 3 months in duration

• Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).

• Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria:

• Current diagnosis of ulcerative colitis or indeterminate colitis

• Complications of Crohn's disease that require surgical intervention or confound efficacy assessments

• Unstable doses of concomitant Crohn's disease therapy