A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

Conditions

• Fistulizing Crohns Disease
• Perianal Crohns Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Guselkumab — DRUG
  Guselkumab will be administered subcutaneously/IV infusion.
• Placebo — DRUG
  Matching placebo will be administered subcutaneously/IV infusion.

Study Details

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.

Key Dates

Start date

Sep 27, 2022

Status verified

Jun 2026

Primary completion

Mar 25, 2027

Completion

Mar 25, 2027

Study Design

Enrollment

288 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1: Guselkumab
  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.
• Experimental: Group 2: Guselkumab
  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.
• Experimental: Group 3: Placebo
  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.

Primary Outcome Measure

Percentage of Participants who Achieve Combined Fistula Remission at Week 24 [ Time Frame: Week 24 ]

Locations (15)

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