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A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

NCT05197049 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-05-08

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Conditions

  • Crohn Disease

Interventions

DRUG

Guselkumab Dose 1

Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

DRUG

Guselkumab Dose 2

Guselkumab (Dose 2) will be administered by SC injection.

DRUG

Guselkumab Dose 3

Guselkumab (Dose 3) will be administered by SC injection.

DRUG

Placebo

Placebo will be administered by SC injection.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-19
Primary Completion
2023-07-04
Completion
2028-10-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Bosnia and Herzegovina
  • Brazil
  • Canada
  • China
  • Croatia
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Jordan
  • Lithuania
  • Malaysia
  • Netherlands
  • New Zealand
  • Poland
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

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 NCT05197049 on ClinicalTrials.gov