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 (FUZION CD)
Interventional
Phase 3
Janssen-Cilag Ltd. (Voir sur ClinicalTrials)
septembre 2022
mai 2027
07 décembre 2024
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
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Lyon Sud - 69495 - Pierre-Benite - France | Contact (sur clinicalTrials) | ||||
| CHRU Hopital de Pontchaillou - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| CHRU Nancy Brabois - 54511 - Vandoeuvre les Nancy - France | Contact (sur clinicalTrials) | ||||
| CHU de Nice Hopital de l Archet - 06202 - Nice - France | Contact (sur clinicalTrials) | ||||
| Clinique Ambroise Pare - 92200 - Neuilly-sur-Seine - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
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)
- 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)
- 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