Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis

Conditions

• Familial Adenomatous Polyposis (FAP)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• eRapa (encapsulated rapamycin) — DRUG
  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.
• Placebo — DRUG
  Capsules in 28-count round high-density polyethylene bottles with a polypropylene child-resistant screw cap and foil induction seal.

Study Details

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.

Key Dates

Start date

Jul 18, 2025

Status verified

Jun 2026

Primary completion

Jul 31, 2030

Completion

Jan 31, 2031

Study Design

Enrollment

168 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: eRapa
  0.5 mg eRapa once a day (QD) every other week
• Placebo Comparator: Placebo
  Placebo once a day (QD) every other week

Primary Outcome Measure

Progression-free survival (PFS) in high-risk patients with FAP treated with eRapa versus placebo. [ Time Frame: 3 years ]

Central Contacts

• Vice President Clinical Operations
  XXX-XXX-XXXX
  [email protected]

Locations (18)

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