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

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis

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.

Detailed Summary:
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome: 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.

Original Primary Outcome: 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.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Janssen Research & Development, LLC

Dates:
Date Received: September 15, 2023
Date Started: October 09, 2023
Date Completion: October 09, 2023
Last Updated: December 05, 2023
Last Verified: December 01, 2023