Status:
ACTIVE_NOT_RECRUITING
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2026
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT06049017
Start Date
October 9 2023
End Date
January 16 2026
Last Update
December 19 2025
Active Locations (177)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinnova Research
Anaheim, California, United States, 92805
2
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
3
Medical Associates Research Group, Inc.
San Diego, California, United States, 92123
4
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907