A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (NCT06049017) | Clinical Trial Compass
CompletedPhase 2
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
United States252 participantsStarted 2023-10-09
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Percentage of Participants with Clinical Response at Week 12