RecruitingPhase 3NCT06950385

Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis

A Phase 3, Multi-Site, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of eRapa to Improve Clinical Outcomes in Patients With Familial Adenomatous Polyposis

Sponsor

Rapamycin Holdings Inc.

Enrollment

168 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Familial Adenomatous Polyposis (FAP)

Summary

The main goal of this clinical trial is to learn if the drug eRapa works to slow down the progression of disease in patients diagnosed with Familial Adenomatous Polyposis (FAP). Researchers will compare eRapa to Placebo. The questions to be answered by this trial are: * Does taking eRapa help to slow down the progression of the disease in patients with FAP? * Is eRapa a safe treatment for patients diagnosed with FAP? * What is the effect of eRapa on the number of polyps found in GI tract of patients diagnosed with FAP? * How does treatment with eRapa affect a patient's quality of life? Participants will: * Take eRapa or placebo once per day every other week until disease progresses (gets worse), stops taking part in the trial or dies. * Visit the clinic once every 3 months for check ups and tests. * Have an endoscopy at the start of the trial and then every 6 months to check on whether the disease is getting better or worse.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is testing a drug called eRapa (a slow-release form of rapamycin/sirolimus) in people with familial adenomatous polyposis (FAP) — a hereditary condition that causes hundreds of polyps (pre-cancerous growths) to develop in the colon and other parts of the digestive tract. The goal is to see if eRapa can reduce the number or size of these polyps. **You may be eligible if...** - You are 18 years or older - You have a documented FAP genetic mutation - You have a high number of polyps in your colon, retained rectum, or small intestine meeting specific thresholds - You are willing to undergo endoscopic (scope) evaluations during the study **You may NOT be eligible if...** - You have unresected high-grade dysplasia (pre-cancer) or cancer in the colon, rectum, or small intestine - You have uncontrolled serious infections or other significant medical conditions - You are pregnant, planning to become pregnant, or not willing to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGeRapa (encapsulated rapamycin)

0.5 mg capsules for oral use; white opaque capsule filled with off-white powder; Trial intervention will be provided in 28-count round high-density polyethylene bottles with a polypropylene child-resistant screw cap and foil induction seal.

DRUGPlacebo

Capsules in 28-count round high-density polyethylene bottles with a polypropylene child-resistant screw cap and foil induction seal.

Locations(26)

City of Hope

Arcadia, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Georgetown University

Washington D.C., District of Columbia, United States

Digestive & Liver Center of Florida

Orlando, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

University of Chicago

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Johns Hopkins University

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Department of Surgery, Section of Colon Rectal and Surgery

St Louis, Missouri, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Benaroya Research Institute at Virginia Mason

Seattle, Washington, United States

University of Washington - Fred Hutchinson

Seattle, Washington, United States

Copenhagen University Hospital

Copenhagen, Denmark

Universitätsklinikum Bonn

Bonn, Germany

Amsterdam UMC

Amsterdam, Netherlands

Radboud University Medical Center

Nijmegen, Netherlands

Hospital Oncologico - Puerto Rico Medical Center

Rio Piedras, Puerto Rico

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Comarcal de Inca

Inca, Spain

Hospital La Fe de Valencia

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT06950385