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

NCT05347095 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2026-05-08

No results posted yet for this study

Summary

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.

Conditions

  • Fistulizing Crohns Disease
  • Perianal Crohns Disease

Interventions

DRUG

Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

DRUG

Placebo

Matching placebo will be administered subcutaneously/IV infusion.

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Ltd. Clinical Trial · Janssen-Cilag Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-27
Primary Completion
2027-03-25
Completion
2027-03-25
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Egypt
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Jordan
  • Netherlands
  • Poland
  • Portugal
  • Saudi Arabia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05347095 on ClinicalTrials.gov