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

Phase 3 Active, not recruiting NCT05528510

Condition	Colitis, Ulcerative
Phase	Phase 3
Sponsor	Janssen Research & Development, LLC
Status	Active, not recruiting
Enrollment	418 participants
Interventions	Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3
Start date	Sep 13, 2022
Completion date	Apr 2, 2024
Results posted	Dec 9, 2025

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).

Percentage of Participants in Clinical Remission at Week 12

Week 12 · Percentage of participants

Placebo	6.5 Percentage of participants
Combined Guselkumab 400 mg	27.6 Percentage of participants

p-value	<0.001
Adjusted Treatment Difference	21.1 (95% CI 14.5–27.6)

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Coliti — Janssen Research & Development, LLC
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Efficacy and Mechanism of Fecal Microbiota Transplantation of the Bai Ethnicity in the Tre — First Affiliated Hospital of Kunming Medical University
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This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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