A Study of Guselkumab Therapy in Participants with Moderately to Severely Active Ulcerative Colitis
Phase 3
Recruiting
- Conditions
- Colitis, Ulcerative
- Registration Number
- JPRN-jRCT2031220426
- Lead Sponsor
- umaguchi Hirotaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Signed informed consent form
- 18 years of age or older
- Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
- Moderately to severely active UC as per the modified Mayo score
- Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in
the protocol
Exclusion Criteria
- Diagnosis of indeterminate colitis, microscopic colitis,
ischemic colitis, or Crohn's disease
- Surgery within 8 weeks before screening or planned
surgery during the study that may confound the evaluation
of benefit from study intervention
- Receiving prohibited medications and treatments
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method