A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease (FUZION CD)
Purpose of this study:
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.
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.
- Is naïve to biologics, or demonstrated inadequate response or intolerance to conventional therapies or approved biologic therapies for Crohn's Disease (CD)
Exclusion Criteria:
- Has a very severe luminal disease activity.
- History of or concurrent rectovaginal fistulas, rectal and/or anal stenosis or other active complications of perianal disease.
- 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.
Primary outcome measures:
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 outcome measures:
Combined Fistula Remission at Week 48
Percentage of Participants who Achieve Clinically Assessed Fistula Remission at week 24
Percentage of Participants who Achieve Radiological Fistula Remission at week 24
Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 24
Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 12
Change from Baseline in Crohn's Disease Activity Index (CDAI) by Visit Over Time Through Week 48
For more outcome measures please see
https://classic.clinicaltrials.gov/ct2/show/NCT05347095?term=NCT05347095&draw=2&rank=1
Study Locations in Europe: Czechia, France, Greece, Hungary, Italy, Netherlands, Poland,
Portugal, Spain, UK
Note: The list of EU countries is still not final
Estimated Study Completion Date: September 8, 2027
Further information on clinicaltrial.gov - trial number NCT05347095
Investigators: Janssen-Cilag Ltd.