Fistulizing Crohns Disease Perianal Crohns Disease
Conditions
Interventions
'- Guselkumab:Drug:Group 1: Guselkumab:Group 2: Guselkumab:Group 3: Placebo:Guselkumab will be administered subcutaneously/IV infusion.
- Placebo:Drug:Group 1: Guselkumab:Group 2: Guselkumab:Group 3:
Sponsors
Sakamoto Takehiko
Eligibility
Sex/Gender
All
Inclusion 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 - Has previously demonstrated lack of initial response (that is primary nonresponders), 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 criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants who Achieve Combined Fistula Remission at Week 24:Week 24:Percentage of participants who achieve combined fistula remission at Week 24 will be reported. Combined fistula remission is defined as 100 percentage (%) closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings [occurring spontaneously or after gentle finger compression] and absence of collections greater than (>) 2 centimeters (cm) of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the magnetic resonance imaging [MRI] results. | — |
Secondary
| Measure | Time frame |
|---|---|
| Refer to Appendix | — |
Countries
Australia, Belgium, Canada, Czechia, Egypt, France, Germany, Greece, Hungary, Israel, Italy, Japan, Jordan, Netherlands, Poland, Portugal, Republic Of Korea, Saudi Arabia, Spain, Sweden, Taiwan Province Of China, Turkiye, United Kingdom Of Great Britain, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed