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A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
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 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
178
Start Date
2021-07-14
Completion Date
2025-07-14
Last Updated
2026-09-01
Healthy Volunteers
No
Conditions
Interventions
Tulisokibart
Administered by IV infusion
Companion Diagnostic (CDx) Testing
PRA023 CDx Genotyping Assay
Placebo
Placebo administered by IV infusion
Locations (88)
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Sun City, Arizona, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Bristol, Connecticut, United States
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Atlanta, Georgia, United States
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Arlington Heights, Illinois, United States
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Glenview, Illinois, United States
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Gurnee, Illinois, United States
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Kansas City, Kansas, United States
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Liberty, Kansas, United States
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Baton Rouge, Louisiana, United States
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Chevy Chase, Maryland, United States
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Chesterfield, Michigan, 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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New York, New York, United States
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Dublin, Ohio, United States
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Germantown, Tennessee, United States
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Bedford, Texas, United States
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Lubbock, Texas, United States
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Mansfield, 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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Charlottesville, Virginia, United States
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Tacoma, Washington, United States
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Woodville, Adelaide, Australia
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Kingswood, New South Wales, Australia
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Old Toongabbie, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Adelaide, South Australia, Australia
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Fitzroy, Victoria, Australia
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Melbourne, Victoria, Australia
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Leuven, Belgium
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Liège, Belgium
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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North York, Ontario, Canada
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Brno, Czechia
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Hradec Králové, Czechia
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Olomouc, Czechia
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Slaný, Czechia
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Clichy, France
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Lille, France
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Nice, France
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Pierre-Bénite, France
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Saint-Priest-en-Jarez, France
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Vandœuvre-lès-Nancy, France
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Tbilisi, Georgia
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Győr, Győr-Moson-Sopron, Hungary
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Békéscsaba, Hungary
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Budapest, Hungary
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Budapest, Hungary
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Budapest, Hungary
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Afula, Israel
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Beersheba, Israel
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Holon, Israel
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Jerusalem, Israel
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Petah Tikva, Israel
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Bologna, Emilia-Romagna, Italy
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Milan, Milan, Italy
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Milan, Milan, Italy
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Roma, Rome, Italy
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Poznan, Greater Poland Voivodeship, Poland
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Włocławek, Kuuavian-Pomeranian, Poland
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Krakow, Lesser Poland Voivodeship, Poland
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Wroclaw, Lower Silesian Voivodeship, Poland
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Wroclaw, Lower Silesian Voivodeship, Poland
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Warsaw, Masovia, Poland
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Katowice, Silesian, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Lublin, Poland
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Rzeszów, Poland
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Sopot, Poland
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Szczecin, Poland
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Torun, Poland
Prometheus Biosciences Selected Site #2
Warsaw, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Prescot, Merseyside, United Kingdom
Prometheus Biosciences Selected Sites
London, United Kingdom