clinical trial · NCT04996797
A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·phase2·completed·n = 178
Ulcerative ColitisTulisokibartCompanion Diagnostic (CDx) TestingPlacebo
brief 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.
started
Jul 14, 2021
primary completion
Jun 6, 2023
completion
Jul 14, 2025
last updated
Sep 1, 2026
official title
A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol