Status:
ACTIVE_NOT_RECRUITING
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2029
Estimated Enrollment :
577 Patients enrolled
Trial Details
Trial ID
NCT05242484
Start Date
September 19 2022
End Date
March 27 2029
Last Update
December 5 2025
Active Locations (403)
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1
Valley Gastroenterology Medical Group
Arcadia, California, United States, 91006
2
Southern California Research Center
Coronado, California, United States, 92118
3
Om Research LLC
Lancaster, California, United States, 93534
4
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048