A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
NCT ID: NCT04996797
Last Updated: 2025-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
178 participants
INTERVENTIONAL
2021-07-14
2025-07-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1 Tulisokibart
Participants who are CDx+ and CDx- will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. 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.
Tulisokibart
Administered by IV infusion
Cohort 1 Placebo
Participants who are CDx+ and CDx- will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. 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.
Placebo
Placebo administered by IV infusion
Cohort 2 Tulisokibart
Participants who are CDx+ will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0 and 500 mg on the first day of Weeks 2, 6, and 10. 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.
Tulisokibart
Administered by IV infusion
Companion Diagnostic (CDx) Testing
PRA023 CDx Genotyping Assay
Cohort 2 Placebo
Participants who are CDx+ will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. 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.
Companion Diagnostic (CDx) Testing
PRA023 CDx Genotyping Assay
Placebo
Placebo administered by IV infusion
Interventions
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Tulisokibart
Administered by IV infusion
Companion Diagnostic (CDx) Testing
PRA023 CDx Genotyping Assay
Placebo
Placebo administered by IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has moderately to severely active UC as defined by 3-component Modified Mayo score
* Must have corticosteroid dependence or have had no response, insufficient response, loss of response, and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (anti-TNF), anti-integrin, anti-interleukin 12/23 (anti-IL12/23), Janus kinase (JAK) inhibitor, Sphingosine 1-phosphate receptor (S1PR) modulator.
Exclusion Criteria
* Has current evidence of fulminant colitis, toxic megacolon, bowel perforation, total proctocoloectomy or partial colectomy
* Has current or impending need for colostomy or ileostomy
* Has had surgical bowel resection within 3 months before screening
* Has past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed
18 Years
ALL
No
Sponsors
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Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Prometheus Biosciences Selected Center
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
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London, , United Kingdom
Countries
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References
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Sands BE, Feagan BG, Peyrin-Biroulet L, Danese S, Rubin DT, Laurent O, Luo A, Nguyen DD, Lu J, Yen M, Leszczyszyn J, Kempinski R, McGovern DPB, Ma C, Ritter TE, Targan S; ARTEMIS-UC Study Group. Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis. N Engl J Med. 2024 Sep 26;391(12):1119-1129. doi: 10.1056/NEJMoa2314076.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-7240-005
Identifier Type: OTHER
Identifier Source: secondary_id
PRA023
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509741-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1309-6078
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-000091-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PR200-102
Identifier Type: -
Identifier Source: org_study_id
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