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Clinical Trials in the UK / NCT07577856
Recruiting Phase 3

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

NCT07577856 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2026-05-23
Last updated
2026-08-28

Condition(s) studied

Colitis, Ulcerative

Investigational drug(s) / intervention(s)

JNJ-78934804Guselkumab

JNJ-78934804: JNJ-78934804 will be administered subcutaneously.

Guselkumab: Guselkumab will be administered subcutaneously.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (170)

FacilityCityRegionStatus
Clinnova Research Anaheim California Recruiting
Gastro SB Clinic Chula Vista California Recruiting
United Medical Doctors Los Alamitos California Recruiting
Medical Associates Research Group, Inc. San Diego California Recruiting
Peak Gastroenterology Associates Colorado Springs Colorado Recruiting
Florida Research Center Inc. Lakewood Rch Florida Recruiting
Sanchez Clinical Research, Inc Miami Florida Recruiting
GCP Clinical Research Tampa Florida Recruiting
Atlanta Gastroenterology Specialists Suwanee Georgia Recruiting
Tri-State Gastroenterology Assoc Crestview Hills Kentucky Recruiting
Gastroenterology Clinic of Acadiana Lafayette Louisiana Recruiting
Michigan Center of Medical Research Farmington Hills Michigan Recruiting
New York Gastroenterology Associates New York New York Recruiting
Great Lakes Gastroenterology Research, LLC Mentor Ohio Recruiting
Digestive Disease Specialists Inc Oklahoma City Oklahoma Recruiting
The Oregon Clinic Portland Oregon Recruiting
Gastro One Cordova Tennessee Recruiting
Southern Star Research Institute, LLC San Antonio Texas Recruiting
Tyler Research Institute, LLC Tyler Texas Recruiting
GI Alliance Tacoma Tacoma Washington Recruiting
GEDYT AAI Argentina Recruiting
Instituto Medico De Alta Complejidad (IMAC) Buenos Aires Argentina Recruiting
Globalpsy La Plata Argentina Recruiting
HIGEA Mendoza Argentina Recruiting
Instituto de Investigaciones Clinicas Quilmes Quilmes Argentina Recruiting
MR Medicina Reumatologica San Fernando Argentina Recruiting
Banksia Trials SA Adelaide Australia Recruiting
Royal Prince Alfred Hospital Camperdown Australia Recruiting
Monash Medical Centre Clayton Australia Recruiting
The Melbourne Gut Clinic Epworth Hospital East Melbourne Australia Recruiting
SA Gastrointestinal Services Kurralta Park Australia Recruiting
Fiona Stanley Hospital Murdoch Australia Recruiting
John Hunter Hospital New Lambton Heights Australia Recruiting
Mater Misericordiae Hospital South Brisbane Australia Recruiting
Imelda Bonheiden Bonheiden Belgium Recruiting
AZ Sint-Lucas Bruges Belgium Recruiting
ULB Erasme Ziekenhuis Brussels Belgium Recruiting
UZ Brussel Brussels Belgium Recruiting
AZ Maria Middelares Ghent Belgium Recruiting
Ghent University Hospital Ghent Belgium Recruiting

+ 130 more sites — see the full list on the official registry below.

On this site

📄 Tremfya (guselkumab) drug profile →

More Janssen Research & Development, LLC trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07577856 on ClinicalTrials.gov ↗ ← All trials in the UK