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

• Status: Not yet recruiting
• Trial end date: 2024-10-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Golimumab

Criteria

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)