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A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis

Purpose

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.

Condition

Colitis, Ulcerative

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Group 1: JNJ-77242113 Dose-1	Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.	Drug: JNJ-77242113 JNJ-77242113 tablet will be administered orally.
Experimental Group 2: JNJ-77242113 Dose-2	Participants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.	Drug: JNJ-77242113 JNJ-77242113 tablet will be administered orally.
Experimental Group 3: JNJ-77242113 Dose-3	Participants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.	Drug: JNJ-77242113 JNJ-77242113 tablet will be administered orally.
Experimental Group 4: Placebo	Participants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76.	Drug: JNJ-77242113 JNJ-77242113 tablet will be administered orally. Drug: Placebo Placebo tablet will be administered orally.

Recruiting Locations

More Details

NCT ID: NCT06049017
Status: Active, not recruiting
Sponsor: Janssen Research & Development, LLC

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.