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Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis

NCT06950385 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Familial Adenomatous Polyposis (FAP)

Interventions

DRUG

eRapa (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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Biodexa Pharmaceuticals

    collaborator INDUSTRY

  • Rapamycin Holdings Inc.

    lead INDUSTRY

Principal Investigators

  • Gary Shangold, MD · Biodexa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-18
Primary Completion
2030-07-31
Completion
2031-01-31
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Germany
  • Netherlands
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06950385 on ClinicalTrials.gov