Using the Drug eRapa to Prevent the Growth of Polyps in People with Familial Adenomatous Polyposis (SERENTA)

About the Study

This study is a Phase 3 clinical trial known as SERENTA. The purpose of this trial is to find out if a medication called eRapa can help people with Familial Adenomatous Polyposis (FAP) who are at high risk of disease progression. 

People will be assigned at random to one of two groups. 

Group One: 

• Take the study drug eRapa by mouth every other week until the disease gets worse.
• Have checkups and tests every 3 months.
• Have an endoscopy at the start of the study and then every 6 months to check on whether the disease is getting better or worse.

Group Two:

• Take a placebo by mouth every other week until the disease gets worse. 
•  Have checkups and tests every 3 months.
• Have an endoscopy at the start of the study and then every 6 months to check on whether the disease is getting better or worse.

People 18 years or older with FAP can participate if they have any one of the following:

• more than 100 polyps but less than 501 polyps in the colon, or
• 10 or more polyps in the retained rectum/sigmoid or ileal pouch that are 3 mm or larger, or
• Spigelman stage 3 or 4 with at least 1 polyp that is 10 mm or larger to be removed at baseline or on endoscopy performed within 18 months of screening.

People cannot participate if they:

• have high-grade dysplasia or cancer within the duodenum, colon, rectum, or ileal pouch that has not be completely removed at the time of screening endoscopy.
• have had surgery within 6 weeks of starting on the study.
• have an active cancer or a cancer diagnosis within 2 years before starting on the study. 
• have any active infection or medical condition that might affect participation in the study.