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: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-07
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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
4.2 Is naïve to biologics, or has previously demonstrated lack of initial response (ie, primary non-responders), responded initially but then lost response with continued therapy (ie, secondary non-responders), 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)
5.1 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).

Please refer to protocol section 5.1 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, 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 section 5.2 for the complete list of exclusion criteria.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: - To evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn’s disease<br>- To assess the overall safety of guselkumab<br> ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint of this study is the proportion of participants who achieve combined fistula remission at Week 24;Timepoint(s) of evaluation of this end point: At Week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Major Secondary Endpoints:<br>1 Combined fistula remission<br>2 Clinically assessed fistula remission<br>3 Radiological fistula remission based on radiological findings assessed by MRI <br>4 Clinically assessed fistula response at Week 24<br>5 clinically assessed fistula response at Week 12;Timepoint(s) of evaluation of this end point: Timepoints of Major Secondary Endpoints:<br>1 - Combined fistula remission at Week 48<br>2- Clinically assessed fistula remission at Week 24<br>3 - Radiological fistula remission based on radiological findings assessed by MRI at Week 24<br>4 - Clinically assessed fistula response at Week 12 and 24<br>