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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)
A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)

NCT04996797

CompletedPhase 2

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

Conditions: Ulcerative Colitis

Interventions: Tulisokibart, Companion Diagnostic (CDx) Testing, Placebo

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

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Confirmed diagnosis of ulcerative colitis (UC)
* 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:

The main exclusion criteria include but are not limited to the following:

* Has diagnosis of Crohn's disease or indeterminate colitis
* 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
Locations (88)
  • Mobile, Alabama, United States
  • Phoenix, Arizona, United States
  • Sun City, Arizona, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • San Diego, California, United States
  • Bristol, Connecticut, United States
  • Atlanta, Georgia, United States
  • Arlington Heights, Illinois, United States
  • Glenview, Illinois, United States
  • Gurnee, Illinois, United States
  • Kansas City, Kansas, United States
  • Liberty, Kansas, United States
  • Baton Rouge, Louisiana, United States
  • Chevy Chase, Maryland, United States
  • Chesterfield, Michigan, United States
  • Lebanon, New Hampshire, United States
  • New York, New York, United States
  • New York, New York, United States
  • Dublin, Ohio, United States
  • Germantown, Tennessee, United States
  • Bedford, Texas, United States
  • Lubbock, Texas, United States
  • Mansfield, Texas, United States
  • San Antonio, Texas, United States
  • Southlake, Texas, United States
  • Tyler, Texas, United States
  • Charlottesville, Virginia, United States
  • Tacoma, Washington, United States
  • Woodville, Adelaide, Australia
  • + 58 more on CT.gov