A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis
- Conditions
- Moderately to Severely Active Ulcerative ColitisTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2023-504718-31-00
- Lead Sponsor
- Janssen - Cilag International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1471
1. Male or female, 18 years of age or older, 2. Documented diagnosis of UC at least 3 months before screening, 3. Moderately to severely active UC as defined by baseline modified Mayo score, 4. History of inadequate response to or failure to tolerate conventional or advanced therapy as defined in the protocol, 5. Screening laboratory test results within the study protocol defined parameters
1. Severe extensive colitis as defined in the study protocol, 2. UC limited to the rectum only, 3. Presence of a stoma, 4. Presence or history of a fistula, 5. Presence of symptomatic colonic or small bowel obstruction, 6. History of extensive colonic resection, 7. History of colonic mucosal dysplasia, 8. Indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method