Phase 1b2 Multicenter Study of REC-4881 to Treat Familial Adenomatous Polyposis FAP Affecting the Duodenum or ColonRectumPouch

What this Trial Is About

Researchers are evaluating REC-4881 in people with Familial Adenomatous Polyposis FAP, a condition affecting the digestive tract. This Phase 1b2 trial focuses on participants with classical FAP involving the duodenum or residual colon, rectum, or pouch. The study aims to assess the drugs safety, how it moves through and affects the body, and its impact on the disease. Participants will be assigned to one of several groups receiving different doses or schedules of REC-4881 or a placebo. Treatments include single doses followed by daily doses for two weeks, 12 weeks of daily dosing followed by 12 weeks off, or intermittent dosing over 24 weeks. The study includes two parts, with initial short-term dosing and later longer treatment periods. During the study, participants will undergo regular assessments including blood tests to measure drug levels and monitor safety, endoscopies to evaluate polyp changes, and heart and liver function tests. Researchers will track side effects, dose adjustments, and changes in polyp number and size over up to 37 weeks. Participation involves multiple visits to monitor response and safety throughout the treatment and follow-up periods.

Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)