Status:
ACTIVE_NOT_RECRUITING
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Lead Sponsor:
Janssen-Cilag Ltd.
Conditions:
Fistulizing Crohns Disease
Perianal Crohns Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- Has previously demonstrated lack of initial response (that is primary non-responders), responded initially but then lost response with continued therapy (that is secondary non-responders), or were intolerant to a maximum of 2 classes of advanced drug therapies at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents) or JAK inhibitors licensed for Crohn's disease treatment (that is, upadacitinib)
Exclusion
- Has a very severe luminal disease activity
- History of concurrent rectovaginal fistulas (other types of concurrent fistula should be confirmed with the sponsor), rectal and/or anal stenosis, stoma or functioning ostomy (include all current stoma types abscess or collections which are not properly drained) colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus
- 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
Key Trial Info
Start Date :
September 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2027
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT05347095
Start Date
September 27 2022
End Date
March 25 2027
Last Update
December 22 2025
Active Locations (153)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Yale University
New Haven, Connecticut, United States, 06510
3
University of Miami
Miami, Florida, United States, 33136
4
Gastroenterology Group Of Naples
Naples, Florida, United States, 34102