A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

• Status: Not yet recruiting
• Trial end date: 2025-05-08
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.

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

Details

• Lead Sponsor: Janssen-Cilag Ltd.

Criteria

Inclusion Criteria:

• Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months

• Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results

• Is naïve to biologics, or demonstrated inadequate response or intolerance to conventional therapies or approved biologic therapies for Crohn's Disease (CD)

Exclusion Criteria:

• Has a very severe luminal disease activity

• History of or concurrent rectovaginal fistulas, rectal and/or anal stenosis or other active complications of perianal disease

• Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation

• Any medical contraindications preventing study participation

• Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease