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

ID#: NCT05347095

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: July 18, 2022

End Date: May 08, 2025

Contact Information:
Study Contact
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.

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