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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT05242484

Run by

Janssen Research & Development, LLC

People needed

577

Starts

2022-09-19

Expected to finish

2029-03-27

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Southern California Research Center — Coronado, California, United States
• Om Research LLC — Lancaster, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Medical Research Center of Connecticut — Hamden, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Pioneer Research Solutions Inc. — Coconut Creek, Florida, United States
• Digestive and Liver Disease Institute — Kissimmee, Florida, United States
• Osceola Regional Hospital — Kissimmee, Florida, United States
• Florida Research Center Inc. — Lakewood Rch, Florida, United States
• University of Miami — Miami, Florida, United States
• Gastroenterology Group Of Naples — Naples, Florida, United States
• Omega Research Consultants — Orlando, Florida, United States
• Synergy Clinical Research — St. Petersburg, Florida, United States
• GCP Clinical Research — Tampa, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Gastroenterolgy Associates of Central GA — Macon, Georgia, United States
• Atlanta Gastroenterology Associates 1 — Marietta, Georgia, United States
• Gastrointestinal Specialists of Georgia — Marietta, Georgia, United States
• Gastroenterology Consultants — Roswell, Georgia, United States
• Grand Teton Gastroenterology — Idaho Falls, Idaho, United States
• Valley Gastroenterology Medical Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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