A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis
- Conditions
- Colitis, Ulcerative
- Registration Number
- JPRN-jRCT2031220308
- Lead Sponsor
- ishikawa Kazuko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 550
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
- 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants with Clinical Remission at Week 48<br>Week 48<br>Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores.
- Secondary Outcome Measures
Name Time Method