A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)

Phase 2 Completed 178 enrolled Prometheus Biosciences, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC). After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.

Timeline

Start: 2021-07-14
Primary completion: 2023-06-06
Completion: 2025-07-14

Outcome

Met primary endpoint

paper A significantly higher percentage of patients who received tulisokibart had clinical remission than those who received placebo PMID 39321363 ↗

paper 26% vs. 1%; difference, 25 percentage points; 95% confidence interval [CI], 14 to 37; P<0.001). PMID 39321363 ↗

Publications

Results Sands BE, Feagan BG, Peyrin-Biroulet L, Danese S, Rubin DT, Laurent O, Luo A, Nguyen DD, Lu J, Yen M, Leszczyszyn J, Kempinski R, McGovern DPB, Ma C, Ritter TE, Targan S; ARTEMIS-UC Study Group. Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis. N Engl J Med. 2024 Sep 26;391(12):1119-1129. doi: 10.1056/NEJMoa2314076.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tulisokibart	Monoclonal antibody	500 mg	Intravenous