At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 55 enrolled
Drug / intervention
Tulisokibart +1 morebiological
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 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Aug 19, 2021·Updated Apr 21, 2026
In Brief
A Phase 2 clinical trial evaluating Tulisokibart and Companion Diagnostic (CDx) for Crohn Disease. Completed, enrolled 55 participants across 37 sites in 8 countries.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of tulisokibart (MK-7240) in participants with moderately to severely active Crohn's Disease. After the completion of the 12-week Induction Period, eligible participants have the option to enter an Open-label Extension (OLE) Period for up to 170 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease
CountriesAustralia, Belgium, Canada, Czechia, France, Georgia, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
Enrollment StartJul 2021
First PostedAug 2021
Primary CompletionSep 2022
Study CompletionMay 2025
TodayJul 2026
First PostedAug 19, 2021
Enrollment StartJul 28, 2021
Primary CompletionSep 23, 2022
Study CompletionMay 27, 2025
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.9 years ago
Interventions
Tulisokibartbiological
Tulisokibart administered by IV infusion as directed by the protocol
Companion Diagnostic (CDx)other
PRA023 CDx Genotyping Assay