Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn's Disease

Phase 3

Active, not recruiting

Conditions: Fistulizing perianal Crohn's Disease

Registration Number: 2023-504740-33-00

Lead Sponsor: Janssen - Cilag International

Brief Summary: To evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruitment ended

Sex: Not specified

Target Recruitment: 190

Inclusion Criteria

Aged 18 years or over

Diagnosis of Crohn's disease with a minimum duration of at least 3 months

At least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening MRI results

Has previously demonstrated lack of initial response, responded initially but then lost response with continued therapy, or were intolerant to a maximum of 2 classes of biologic agents at a dose approved for the treatment of Crohn's disease. OR History of failure to respond to, or tolerate, at least 1 of the following therapies for the treatment of Crohn's disease: oral corticosteroids (including budesonide and beclomethasone dipropionate) or immunomodulators (AZA, 6-MP, MTX).

Had a history of failure to respond to, or tolerate, at least 1 of the following therapies for fistula treatment: antibiotics (ie, ciprofloxacin, metronidazole) and/or immunomodulators (AZA, 6-MP, MTX).

Exclusion Criteria

Has a very severe luminal disease activity (defined as CDAI ≥350).

Has any of the following: - history of or concurrent rectovaginal fistulas, rectal and/or anal stenosis, stoma or functioning ostomy. - colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus.

Has current complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that might be anticipated to require surgery, could preclude any fistula evaluation (both clinical and radiological) to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab.

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is the proportion of participants who achieve combined fistula remission at Week 24		The primary endpoint of this study is the proportion of participants who achieve combined fistula remission at Week 24

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (59): Hippokration Hospital
🇬🇷
Athens, Greece
University General Hospital Of Heraklion
🇬🇷
Heraklion, Greece
General University Hospital Of Patras
🇬🇷
Patras, Greece
Alexandra Hospital
🇬🇷
Athens, Greece
Ippokratio General Hospital Of Thessaloniki
🇬🇷
Thessaloniki, Greece
Evangelismos S.A.
🇬🇷
Athens, Greece
General University Hospital Of Larissa
🇬🇷
Larissa, Greece
Thoracic General Hospital Of Athens I Sotiria
🇬🇷
Athens, Greece
Central Hospital Of Northern Pest Military Hospital
🇭🇺
Budapest VI, Hungary
University Of Pecs
🇭🇺
Pecs, Hungary
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Hippokration Hospital
🇬🇷Athens, Greece
Spilios Manolakopoulos
Site contact
30105244694
smanolak@med.uoa.gr