Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Interventional
Phase 3
Janssen-Cilag Ltd. (Voir sur ClinicalTrials)
septembre 2022
mars 2027
02 décembre 2025
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.
Etablissements
| Etablissement | Contact | Statut | Actualisé | ||
|---|---|---|---|---|---|
| Etablissement non spécifié, référez vous à la page NCT pour plus d'information Origine et niveau de fiabilité des données | |||||
Critères
Tous
- 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 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