A Study of JNJ-77242113 in Participants with Moderately to Severely Active Ulcerative Colitis
- Conditions
- Colitis, Ulcerative
- Registration Number
- JPRN-jRCT2031230383
- Lead Sponsor
- akano Masayoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
Signed informed consent form 18 years of age or older
- Documented diagnosis of ulcerative colitis (UC) 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 advanced therapy as defined in the protocol
- Participants with current or prior diagnosis of fulminant colitis and/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, <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 Percentage of Participants with Clinical Response at Week 12<br>Week 12<br>Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
- Secondary Outcome Measures
Name Time Method