Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Janssen-Cilag Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
