Sponsor: Janssen

Key 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)

Key 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. Please note that this is not the final list of countries)

Estimated Study Completion Date: September 8, 2027

Further information on clinicaltrial.gov - trial number NCT05347095