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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)
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)

NCT05013905

CompletedPhase 2

Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Conditions: Crohn Disease

Interventions: Tulisokibart, Companion Diagnostic (CDx)

Countries: United States, Australia, Belgium, Canada, Czechia, France, Georgia, Poland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Confirmed diagnosis of Crohn's disease (CD)
* 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:

* Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug
* 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
* Participants in the opinion of the investigator are at an unacceptable risk for participation in the study
* Participants who meet the protocol criteria for important laboratory exclusion criteria
Locations (37)
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Liberty, Kansas, United States
  • Chesterfield, Michigan, United States
  • Ypsilanti, Michigan, United States
  • St Louis, Missouri, United States
  • Lebanon, New Hampshire, United States
  • New York, New York, United States
  • Garland, Texas, United States
  • Lubbock, Texas, United States
  • Lubbock, Texas, United States
  • San Antonio, Texas, United States
  • Southlake, Texas, United States
  • Tyler, Texas, United States
  • Bellevue, Washington, United States
  • Tacoma, Washington, United States
  • Bankstown, New South Wales, Australia
  • Woolloongabba, Queensland, Australia
  • Adelaide, South Australia, Australia
  • Leuven, Belgium
  • Liège, Belgium
  • London, Ontario, Canada
  • Brno, Czechia
  • Slaný, Czechia
  • Clichy, France
  • Nice, France
  • Saint-Priest-en-Jarez, France
  • Vandœuvre-lès-Nancy, France
  • Tbilisi, Georgia
  • Krakow, Poland
  • + 7 more on CT.gov