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RECRUITING
NCT07577856
PHASE3

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).

Official title: A Phase 3 Randomized, Double-blind, and Active Controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

644

Start Date

2026-05-23

Completion Date

2030-10-30

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

DRUG

JNJ-78934804

JNJ-78934804 will be administered subcutaneously.

DRUG

Guselkumab

Guselkumab will be administered subcutaneously.

Locations (26)

Clinnova Research

Anaheim, California, United States

Gastro SB Clinic

Chula Vista, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Sanchez Clinical Research, Inc

Miami, Florida, United States

GCP Clinical Research

Tampa, Florida, United States

New York Gastroenterology Associates

New York, New York, United States

Southern Star Research Institute, LLC

San Antonio, Texas, United States

SA Gastrointestinal Services

Kurralta Park, Australia

GI Research Institute (G.I.R.I.)

Vancouver, British Columbia, Canada

London Digestive Disease Institute

London, Ontario, Canada

Rambam Medical Center

Haifa, Israel

Bnai Zion Medical Center

Haifa, Israel

Meir Medical Center

Kfar Saba, Israel

Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Matsuda Hospital

Hamamatsu, Japan

National Hospital Organization Mito Medical Center

Higashi-Ibaraki, Japan

Kagoshima IBD Gastroenterology Clinic

Kagoshima, Japan

Oita Red Cross Hospital

Ōita, Japan

Saga University Hospital

Saga, Japan

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

Sapporo, Japan

Hospital Sultanah Nur Zahirah

Kuala Terengganu, Malaysia

Sanko Universitesi Hastanesi

Gaziantep, Turkey (Türkiye)

Bezmialem University Medical Faculty

Istanbul, Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)