FUZION - Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn’s Disease

Phase 1

• Conditions: Fistulizing perianal Crohn's Disease; MedDRA version: 20.0Level: LLTClassification code 10075465Term: Fistulizing Crohn's diseaseSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-000491-10-DE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1. Aged 18 years or over.
2. Diagnosis of Crohn’s disease with a minimum duration of at least 3 months
3. At least one active draining perianal fistula as a complication of Crohn’s disease, confirmed by screening MRI results.

Please refer to protocol for the complete list of inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 224
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

1. Has a very severe luminal disease activity (defined as CDAI =350).
2. Has any of the following:
- history of or concurrent rectovaginal fistulas, rectal and/or anal stenosis (unless the participant undergoes surgical dilation prior to baseline), diverting stomas with anastomotic leakage, 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.
3. 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.

Please refer to protocol for the complete list of exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified