A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease (FUZION CD)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3

Conditions: Perianal Crohns Disease; Fistulizing Crohns Disease

Treatments: Drug: Guselkumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05347095

CNTO1959CRD3005 (Other Identifier)

CR109189

2021-000491-10 (EudraCT Number)

2023-504740-33-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Has previously demonstrated lack of initial response (that is primary non-responders), responded initially but then lost response with continued therapy (that is secondary non-responders), or were intolerant to a maximum of 2 classes of advanced drug therapies at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents) or JAK inhibitors licensed for Crohn's disease treatment (that is, upadacitinib)

Exclusion criteria

• Has a very severe luminal disease activity
• History of concurrent rectovaginal fistulas (other types of concurrent fistula should be confirmed with the sponsor), rectal and/or anal stenosis, stoma or functioning ostomy (include all current stoma types 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 3 patient groups

Group 1: Guselkumab

Experimental group

Description:

Participants will receive guselkumab Dose 1 intravenous (IV) infusion followed by Dose 2 subcutaneously (SC). Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) period and continue to receive guselkumab.

Treatment:

Drug: Placebo

Drug: Guselkumab

Group 2: Guselkumab

Experimental group

Description:

Participants will receive guselkumab Dose 1 IV infusion followed by Dose 3 SC. Participants will receive matching placebo to maintain the blind. At Week 24, guselkumab Dose 3 SC non-responders will switch to receive guselkumab dose 2 SC. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.

Treatment:

Drug: Placebo

Drug: Guselkumab

Group 3: Placebo

Experimental group

Description:

Participants will receive placebo IV infusion followed by placebo SC. At Week 24, placebo non-responders will continue to receive guselkumab Dose 4 followed by guselkumab Dose 2 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.

Treatment:

Drug: Placebo

Drug: Guselkumab