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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)
Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2021-07-28
Completion Date
2025-05-27
Last Updated
2026-04-21
Healthy Volunteers
No
Conditions
Interventions
Tulisokibart
Tulisokibart administered by IV infusion as directed by the protocol
Companion Diagnostic (CDx)
PRA023 CDx Genotyping Assay
Locations (37)
Prometheus Biosciences Selected Site
Los Angeles, California, United States
Prometheus Biosciences Selected Site
Los Angeles, California, United States
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Liberty, Kansas, United States
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Chesterfield, Michigan, United States
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Ypsilanti, Michigan, United States
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St Louis, Missouri, United States
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Lebanon, New Hampshire, United States
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New York, New York, United States
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Garland, Texas, United States
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Lubbock, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Southlake, Texas, United States
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Tyler, Texas, United States
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Bellevue, Washington, United States
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Tacoma, Washington, United States
Prometheus Biosciences Selected Site
Bankstown, New South Wales, Australia
Prometheus Biosciences Selected Site
Woolloongabba, Queensland, Australia
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Adelaide, South Australia, Australia
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Leuven, Belgium
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Liège, Belgium
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London, Ontario, Canada
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Brno, Czechia
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Slaný, Czechia
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Clichy, France
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Nice, France
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Saint-Priest-en-Jarez, France
Prometheus Biosciences Selected Site
Vandœuvre-lès-Nancy, France
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Tbilisi, Georgia
Prometheus Biosciences Selected Center
Krakow, Poland
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Rzeszów, Poland
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Sopot, Poland
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Torun, Poland
Prometheus Biosciences Selected Center
Warsaw, Poland
Prometheus Biosciences Selected Site
Warsaw, Poland
Prometheus Biosciences Selected Center
Warsaw, Poland
Prometheus Biosciences Selected Site
Wroclaw, Poland