A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants … (NCT05013905) | Clinical Trial Compass
CompletedPhase 2
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)
United States55 participantsStarted 2021-07-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 …
What they're measuring
1
Adverse Events
Timeframe: Week 12
2
Serious Adverse Events
Timeframe: Week 12
3
Adverse Events Leading to Discontinuation
Timeframe: Week 12
4
Endoscopic Improvement
Timeframe: Week 12
Trial details
NCT IDNCT05013905
SponsorPrometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)