A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
NCT ID: NCT05013905
Last Updated: 2025-07-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
55 participants
INTERVENTIONAL
2021-07-28
2025-05-27
Brief Summary
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After the completion of the 12-week induction period, all participants have the option to continue in the open-label extension for another 38 weeks.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PRA023
Participants to receive PRA023 administered by intravenous (IV) infusion.
PRA023 IV
PRA023 administered at timepoints as directed by the protocol
Companion diagnostic (CDx)
CDx+ or CDx-
Interventions
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PRA023 IV
PRA023 administered at timepoints as directed by the protocol
Companion diagnostic (CDx)
CDx+ or CDx-
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy
* 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 (TNF), anti-integrin, or anti-interleukin (IL)12/23
* Able to provide written informed consent and understand and comply with the requirements of the study
Exclusion Criteria
* Diagnosis of ulcerative colitis (UC) or indeterminate colitis
* CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or illeal involvement
* Suspected or diagnosed intra-abdominal or perianal abscess at screening
* Current stoma or need for colostomy or ileostomy
* Previous small bowel resection with a combined resected length of \>100 cm or previous colonic resection of \> 2 segments
* Surgical bowel resection within 3 months before screening
* Past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed
* Subjects in the opinion of the investigator are at an unacceptable risk for participation in the study
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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Prometheus Biosciences
Role: STUDY_DIRECTOR
Clinicaltrials Call Center
Locations
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Prometheus Biosciences Selected Site
Los Angeles, California, United States
Prometheus Biosciences Selected Site
Los Angeles, California, United States
Prometheus Biosciences Selected Site
Liberty, Kansas, United States
Prometheus Biosciences Selected Site
Chesterfield, Michigan, United States
Prometheus Biosciences Selected Site
Ypsilanti, Michigan, United States
Prometheus Biosciences Selected Site
St Louis, Missouri, United States
Prometheus Biosciences Selected Site
Lebanon, New Hampshire, United States
Prometheus Biosciences Selected Site
New York, New York, United States
Prometheus Biosciences Selected Site
Garland, Texas, United States
Prometheus Biosciences Selected Site
Lubbock, Texas, United States
Prometheus Biosciences Selected Site
Lubbock, Texas, United States
Prometheus Biosciences Selected Site
San Antonio, Texas, United States
Prometheus Biosciences Selected Site
Southlake, Texas, United States
Prometheus Biosciences Selected Site
Tyler, Texas, United States
Prometheus Biosciences Selected Site
Bellevue, Washington, United States
Prometheus Biosciences Selected Site
Tacoma, Washington, United States
Prometheus Biosciences Selected Site
Bankstown, New South Wales, Australia
Prometheus Biosciences Selected Site
Woolloongabba, Queensland, Australia
Prometheus Biosciences Selected Site
Adelaide, South Australia, Australia
Prometheus Biosciences Selected Site
Leuven, , Belgium
Prometheus Biosciences Selected Site
Liège, , Belgium
Prometheus Biosciences Selected Site
London, Ontario, Canada
Prometheus Biosciences Selected Site
Brno, , Czechia
Prometheus Biosciences Selected Site
Slaný, , Czechia
Prometheus Biosciences Selected Site
Clichy, , France
Prometheus Biosciences Selected Site
Nice, , France
Prometheus Biosciences Selected Site
Saint-Priest-en-Jarez, , France
Prometheus Biosciences Selected Site
Vandœuvre-lès-Nancy, , France
Prometheus Biosciences Selected Site
Tbilisi, , Georgia
Prometheus Biosciences Selected Center
Krakow, , Poland
Prometheus Biosciences Selected Site
Rzeszów, , Poland
Prometheus Biosciences Selected Site
Sopot, , Poland
Prometheus Biosciences Selected Site
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
Countries
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References
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Feagan BG, Sands BE, Siegel CA, Dubinsky MC, Longman RS, Sabino J, Laurent O, Luo A, Lu J, Nguyen DD, Munoz-Elias EJ, Llewellyn H, Wang Y, Jang I, Bilsborough J, Marchelletta R, Towfic F, Yen M, Anderson JK, DuVall A, Kierkus J, Woynarowski M, Al Kharrat H, Targan SR, McGovern DPB. Safety and efficacy of the anti-TL1A monoclonal antibody tulisokibart for Crohn's disease: a phase 2a induction trial. Lancet Gastroenterol Hepatol. 2025 Aug;10(8):715-725. doi: 10.1016/S2468-1253(25)00071-8. Epub 2025 May 30.
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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7240-006
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509742-35-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1309-6108
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-000092-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PR200-103
Identifier Type: -
Identifier Source: org_study_id
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