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Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis
NCT06950385 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Placebo
- DRUG eRapa (encapsulated rapamycin)
Study Locations (20)
Florida
- Digestive & Liver Center of Florida — Orlando
- Cleveland Clinic Florida — Weston
Ohio
- Cleveland Clinic — Cleveland
- Ohio State University — Columbus
Pennsylvania
- Geisinger Medical Center — Danville
- University of Pittsburgh Medical Center — Pittsburgh
Washington
- Benaroya Research Institute at Virginia Mason — Seattle
- University of Washington - Fred Hutchinson — Seattle
Other
- Copenhagen University Hospital — Copenhagen
- Universitätsklinikum Bonn — Bonn
California
- City of Hope — Arcadia
Connecticut
- Yale Cancer Center — New Haven
District of Columbia
- Georgetown University — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2025-07-18 |
| Est. Completion | 2031-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06950385
The ClinicalTrials.gov registry entry for NCT06950385 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rapamycin Holdings, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Familial Adenomatous Polyposis (FAP) appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06950385 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Ohio, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06950385 about?
NCT06950385 is a clinical study titled "Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis". 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 sl...
What is the current status of trial NCT06950385?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 168 participants. The study started on 2025-07-18. Estimated completion is 2031-01.
What conditions does trial NCT06950385 study?
This clinical trial studies the following conditions: Familial Adenomatous Polyposis (FAP). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06950385?
The interventions under investigation include: Placebo (DRUG), eRapa (encapsulated rapamycin) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06950385?
This trial is sponsored by Rapamycin Holdings, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06950385 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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