A Study of JNJ-77242113 in Participants with Moderately to Severely Active Ulcerative Colitis.
- Conditions
- Health Condition 1: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2024/01/061432
- Lead Sponsor
- Johnson and Johnson Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Signed informed consent form 18 years of age or older. Documented diagnosis of ulcerative colitis of 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 or advanced therapy as defined in the protocol
Participants with current or prior diagnosis of fulminant colitis and or or toxic megacolon. UC limited to rectum only or to less than 15 centimeters (cm) of colon. Presence of a stoma. Presence or history of fistula. History of extensive colonic resection (example, less than 30 cm of colon remaining). Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn’s colitis or clinical findings suggestive of Crohn’s disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to 30 percent and greater than or equal to 2 points, with either a greater than or equal to 1 point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.Timepoint: Week 12
- Secondary Outcome Measures
Name Time Method