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Clinical Trial Summary

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.


Clinical Trial Description

The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06052059
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact Toll Free Number
Phone 1-888-577-8839
Email Trialsites@merck.com
Status Recruiting
Phase Phase 3
Start date October 25, 2023
Completion date December 17, 2029

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