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NCT07577856PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

5/23/2026

Completion Date

10/30/2030

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 Criteria

Age Range: 18 years to No maximum

Inclusion criteria: * Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC. * Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy * An endoscopy subscore \>=2 as obtained during central review of the screening video endoscopy * Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies Exclusion criteria: * Isolated proctitis (UC limited to the rectum only or to less than \[\<\] 20 centimeter \[cm\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD * Has a history of or ongoing chronic or recurrent infectious disease * Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab * Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention

Interventions

DRUG

JNJ-78934804

DRUG

Guselkumab

Interested in This Trial?

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Conditions

Colitis, Ulcerative

Locations

Clinnova Research

Anaheim, California 92805

United States

Gastro SB Clinic

Chula Vista, California 91910

United States

Medical Associates Research Group, Inc.

San Diego, California 92123

United States

Peak Gastroenterology Associates

Colorado Springs, Colorado 80907

United States

Sanchez Clinical Research, Inc

Miami, Florida 33157-6575

United States

GCP Clinical Research

Tampa, Florida 33609

United States

Tri-State Gastroenterology Assoc

Crestview Hills, Kentucky 41017

United States

Michigan Center of Medical Research

Farmington Hills, Michigan 48334

United States

New York Gastroenterology Associates

New York, New York 10075

United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio 44060

United States

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma 73114

United States

Southern Star Research Institute, LLC

San Antonio, Texas 78229

United States

Banksia Trials SA

Adelaide, 5000

Australia

SA Gastrointestinal Services

Kurralta Park, 5037

Australia

Mater Misericordiae Hospital

South Brisbane, 4101

Australia

Pesquisare Saude

Santo André, 09080-110

Brazil

BR Trials

São Paulo, 01236 030

Brazil

South Edmonton Gastroenterology Research Clinic

Edmonton, Alberta Code: T6K 4B2

Canada

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

Vancouver, British Columbia V6Z 2K5

Canada

Viable Clinical Research

Kentville, Nova Scotia B4N 0A3

Canada

Barrie GI Associates

Barrie, Ontario L4M 7G1

Canada

Charlton Digestive Disease Centre

Hamilton, Ontario L8N1Y2

Canada

London Digestive Disease Institute

London, Ontario N6K 1M6

Canada

Toronto Immune and Digestive Health Institute Inc

Toronto, Ontario M6A 3B4

Canada

CHUM - Centre hospitalier universitaire de Montreal

Montreal, Quebec H2X 0C1

Canada

The First Affiliated Hospital Sun Yat sen University

Guangzhou, 510080

China

Assuta Medical center

Ashdod, 7747629

Israel

Rambam Medical Center

Haifa, 3109601

Israel

Bnai Zion Medical Center

Haifa, 60910

Israel

Wolfson Medical Center

Holon, 5822012

Israel

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Meir Medical Center

Kfar Saba, 4428164

Israel

Galilee Medical Center

Nahariya, 2210001

Israel

Rabin Medical Center

Petah Tikva, 4941492

Israel

Sheba Medical Center

Ramat Gan, 52621

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239

Israel

Matsuda Hospital

Hamamatsu, 432-8061

Japan

National Hospital Organization Mito Medical Center

Higashi-Ibaraki, 311-3193

Japan

Kagoshima IBD Gastroenterology Clinic

Kagoshima, 892-0843

Japan

Tsujinaka Hospital Kashiwanoha

Kashiwa, 277-0871

Japan

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

Takano Hospital

Kumamoto, 862-0971

Japan

Kitasato University Kitasato Institute Hospital

Minatoku, 108-8642

Japan

National Hospital Organization Osaka National Hospital

Osaka, 540-0006

Japan

Oita Red Cross Hospital

Ōita, 870-0033

Japan

Saga University Hospital

Saga, 849-8501

Japan

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

Sapporo, 060-0033

Japan

National Hospital Organization Shizuoka Medical Center

Shimizu, 411-8611

Japan

Tokyo Metropolitan Bokutoh Hospital

Sumida Ku, 130 8575

Japan

Yamanashi Prefectural Central Hospital

Yamanashi, 400-8506

Japan

Hospital Ampang

Ampang, 68000

Malaysia

Sultan Idris Shah Hospital

Kajang, 43000

Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, 50586

Malaysia

Hospital Sultanah Nur Zahirah

Kuala Terengganu, 20400

Malaysia

Samsung Medical Center

Gangnam Gu, 06351

South Korea

Linkou Chang Gung Memorial Hospital

Taoyuan, 333

Taiwan

Antalya Training And Research Hospital

Antalya, 07100

Turkey (Türkiye)

Sanko Universitesi Hastanesi

Gaziantep, 27090

Turkey (Türkiye)

Bezmialem University Medical Faculty

Istanbul, 34093

Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098

Turkey (Türkiye)

Izmir Sehir Hastanesi

Izmir, 35540

Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, 41001

Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, 33343

Turkey (Türkiye)