A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (DUET-UC)
S
Sashidhar Sagi, MD
Primary Investigator
Overview
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as comparedguselkumab and golimumab in participants with moderately to severely active ulcerativewho have had an inadequate initial response, loss of response, or intolerance to oneved advanced therapy.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Colitis, Ulcerative
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Age: Between 18 Years - 65 Years
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Gender: All
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 onebiologic or novel oral with biologic-like activity
- If female and of childbearing potential, must meet the contraception and reproductionquirements
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,hemic colitis, or Crohn's disease (CD)
- Has a history of, or ongoing, chronic or recurrent infectious disease, including butd to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary(example, pyelonephritis, cystitis), an open, draining, or infectedkin 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 hasbeen treated with no evidence of recurrence within 12 months of first dose of studyvention)
Updated on
03 May 2024.
Study ID: CR109179
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