At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 178 enrolled
Drug / intervention
Tulisokibart +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Aug 9, 2021·Updated Aug 6, 2025
In Brief
A Phase 2 clinical trial evaluating Tulisokibart, Companion Diagnostic (CDx) Testing, and 1 other intervention for Ulcerative Colitis. Completed, enrolled 178 participants across 88 sites in 12 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesAustralia, Belgium, Canada, Czechia, France, Georgia, Hungary, Israel, Italy, Poland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
Enrollment StartJul 2021
First PostedAug 2021
Primary CompletionJun 2023
Study CompletionJul 2025
TodayJul 2026
First PostedAug 9, 2021
Enrollment StartJul 14, 2021
Primary CompletionJun 6, 2023
Study CompletionJul 14, 2025
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.9 years ago
Interventions
Tulisokibartdrug
Administered by IV infusion
Companion Diagnostic (CDx) Testingdevice
PRA023 CDx Genotyping Assay
Placeboother
Placebo administered by IV infusion