A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: July 18, 2022
End Date: May 08, 2025
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
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Conditions:
- Crohn Disease