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Clinical Trials in India / NCT05242484
Active, not recruiting Phase 2

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

NCT05242484 · tracked via the Priya Life Science India tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2
Started
2022-09-19
Last updated
2026-08-28

Condition(s) studied

Colitis, Ulcerative

Investigational drug(s) / intervention(s)

GuselkumabGolimumabJNJ-78934804Placebo

Guselkumab: Guselkumab will be administered as subcutaneous injection.

Golimumab: Golimumab will be administered as subcutaneous injection.

JNJ-78934804: JNJ-78934804 will be administered subcutaneously as per defined regimen.

Placebo: Placebo will be administered as subcutaneous injection.

Study summary

The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline * Moderately to severely active UC as assessed by the modified Mayo score * Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity * If female and of childbearing potential, must meet the contraception and reproduction requirements Exclusion Criteria: * Has severe extensive colitis as defined in the protocol * Extent of inflammatory disease limited to the rectum * Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD) * Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer * Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)

Primary outcome measure(s)

Trial sites (403)

FacilityCityRegionStatus
Valley Gastroenterology Medical Group Arcadia California
Southern California Research Center Coronado California
Om Research LLC Lancaster California
Cedars Sinai Medical Center Los Angeles California
University of California San Francisco San Francisco California
University of Colorado Aurora Colorado
Peak Gastroenterology Associates Colorado Springs Colorado
Medical Research Center of Connecticut Hamden Connecticut
Yale University New Haven Connecticut
MedStar Georgetown University Hospital Washington D.C. District of Columbia
Pioneer Research Solutions Inc. Coconut Creek Florida
Digestive and Liver Disease Institute Kissimmee Florida
Osceola Regional Hospital Kissimmee Florida
Florida Research Center Inc. Lakewood Rch Florida
University of Miami Miami Florida
Gastroenterology Group Of Naples Naples Florida
Omega Research Consultants Orlando Florida
Synergy Clinical Research St. Petersburg Florida
GCP Clinical Research Tampa Florida
Atlanta Gastroenterology Associates Atlanta Georgia
Gastroenterolgy Associates of Central GA Macon Georgia
Atlanta Gastroenterology Associates 1 Marietta Georgia
Gastrointestinal Specialists of Georgia Marietta Georgia
Gastroenterology Consultants Roswell Georgia
Grand Teton Gastroenterology Idaho Falls Idaho
IU Health University Hospital Indianapolis Indiana
Gastroenterology of Southern Indiana New Albany Indiana
Tri-State Gastroenterology Assoc Crestview Hills Kentucky
University of Kentucky Chandler Medical Center Lexington Kentucky
Jewish Hospital Louisville Kentucky
Chevy Chase Clinical Research Chevy Chase Maryland
Beth Israel Deaconess Medical Center Boston Massachusetts
Brigham And Women's Hospital Chestnut Hill Massachusetts
Huron Gastroenterology Associates Center for Digestive Care Ypsilanti Michigan
Washington University St Louis Missouri
Las Vegas Medical Research Las Vegas Nevada
Care Access Las Vegas Las Vegas Nevada
Dartmouth Hitchcock Lebanon New Hampshire
Weill Cornell Medical College New York New York
Lenox Hill Hospital New York New York

+ 363 more sites — see the full list on the official registry below.

On this site

📄 Tremfya (guselkumab) drug profile → 📄 Simponi (golimumab) drug profile →

More Janssen Research & Development, LLC trials in India

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 NCT05242484 on ClinicalTrials.gov ↗ ← All trials in India