A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006)
Phase 2
Completed
NCT05013905
| Condition | Crohn Disease |
|---|
| Phase | Phase 2 |
|---|
| Sponsor | Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
|---|
| Status | Completed |
|---|
| Enrollment | 55 participants |
|---|
| Interventions | Tulisokibart, Companion Diagnostic (CDx) |
|---|
| Start date | Jul 28, 2021 |
|---|
| Completion date | Sep 23, 2022 |
|---|
| Results posted | Nov 1, 2023 |
|---|
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.
Adverse Events
Up to approximately 18 weeks · Participants
| Induction Tulisokibart | 44 Participants |
|---|
Serious Adverse Events
Up to approximately 18 weeks · Participants
| Induction Tulisokibart | 9 Participants |
|---|
Adverse Events Leading to Discontinuation
Up to approximately 12 weeks · Participants
| Induction Tulisokibart | 2 Participants |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
Other trials for this condition
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.