RecruitingPhase 3NCT07577856

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

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

Sponsor

Janssen Research & Development, LLC

Enrollment

644 participants

Start Date

May 23, 2026

Study Type

INTERVENTIONAL

Conditions

Colitis Ulcerative

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Guselkumab and a drug called JNJ-78934804 for people with colitis ulcerative. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-78934804

JNJ-78934804 will be administered subcutaneously.

DRUGGuselkumab

Guselkumab will be administered subcutaneously.

Locations(63)

Clinnova Research

Anaheim, California, United States

Gastro SB Clinic

Chula Vista, California, United States

Medical Associates Research Group, Inc.

San Diego, 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

Tri-State Gastroenterology Assoc

Crestview Hills, Kentucky, United States

Michigan Center of Medical Research

Farmington Hills, Michigan, United States

New York Gastroenterology Associates

New York, New York, United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, United States

Southern Star Research Institute, LLC

San Antonio, Texas, United States

Banksia Trials SA

Adelaide, Australia

SA Gastrointestinal Services

Kurralta Park, Australia

Mater Misericordiae Hospital

South Brisbane, Australia

Pesquisare Saude

Santo André, Brazil

BR Trials

São Paulo, Brazil

South Edmonton Gastroenterology Research Clinic

Edmonton, Alberta, Canada

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

Vancouver, British Columbia, Canada

Viable Clinical Research

Kentville, Nova Scotia, Canada

Barrie GI Associates

Barrie, Ontario, Canada

Charlton Digestive Disease Centre

Hamilton, Ontario, Canada

London Digestive Disease Institute

London, Ontario, Canada

Toronto Immune and Digestive Health Institute Inc

Toronto, Ontario, Canada

CHUM - Centre hospitalier universitaire de Montreal

Montreal, Quebec, Canada

The First Affiliated Hospital Sun Yat sen University

Guangzhou, China

Assuta Medical center

Ashdod, Israel

Rambam Medical Center

Haifa, Israel

Bnai Zion Medical Center

Haifa, Israel

Wolfson Medical Center

Holon, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

Galilee Medical Center

Nahariya, Israel

Rabin Medical Center

Petah Tikva, 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

Tsujinaka Hospital Kashiwanoha

Kashiwa, Japan

Kumamoto University Hospital

Kumamoto, Japan

Takano Hospital

Kumamoto, Japan

Kitasato University Kitasato Institute Hospital

Minatoku, Japan

National Hospital Organization Osaka National Hospital

Osaka, Japan

Oita Red Cross Hospital

Ōita, Japan

Saga University Hospital

Saga, Japan

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

Sapporo, Japan

National Hospital Organization Shizuoka Medical Center

Shimizu, Japan

Tokyo Metropolitan Bokutoh Hospital

Sumida Ku, Japan

Yamanashi Prefectural Central Hospital

Yamanashi, Japan

Hospital Ampang

Ampang, Malaysia

Sultan Idris Shah Hospital

Kajang, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Hospital Sultanah Nur Zahirah

Kuala Terengganu, Malaysia

Samsung Medical Center

Gangnam Gu, South Korea

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

Antalya Training And Research Hospital

Antalya, Turkey (Türkiye)

Sanko Universitesi Hastanesi

Gaziantep, Turkey (Türkiye)

Bezmialem University Medical Faculty

Istanbul, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Izmir Sehir Hastanesi

Izmir, Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT07577856

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