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A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

NCT05528510 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2026-05-11

Study results available
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Summary

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Guselkumab Dose 1

Guselkumab (Dose 1) will be administered as SC injection.

DRUG

Guselkumab Dose 2

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

DRUG

Guselkumab Dose 3

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

OTHER

Placebo

Placebo will be administered as 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
2022-09-13
Primary Completion
2024-04-02
Completion
2028-10-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Japan
  • Jordan
  • Malaysia
  • Mexico
  • New Zealand
  • Poland
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

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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 NCT05528510 on ClinicalTrials.gov