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NCT06950385 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis
A Phase 3 study of Familial Adenomatous Polyposis (FAP), sponsored by Rapamycin Holdings.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 168
- Enrollment target
- 20
- Study locations
NCT06950385: Recruiting Phase 3 study of Familial Adenomatous Polyposis (FAP), sponsored by Rapamycin Holdings.
NCT06950385 is a Phase 3 study of Familial Adenomatous Polyposis (FAP) that is actively recruiting participants, run by Rapamycin Holdings. The registered enrollment target is 168 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06950385, a Phase 3 study of Familial Adenomatous Polyposis (FAP), is actively recruiting participants, sponsored by Rapamycin Holdings.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 168 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
* Death from any cause * Cancer/high-grade dysplasia * Major FAP-related surgery (e.g., colectomy, proctectomy, total proctocolectomy with ileal pouch anal anastomosis \[IPAA\], pouch resection, ileostomy, duodenectomy, or surgical ampullectomy) * Advancement of Spigelman stage (not related solely to increase in polyp number) * Meets criteria for surgery (consistent with United States \[US\] and European Union \[EU\] practice guidelines) (Yang, Gurudu et al. 2020, Zaffaroni, Mannucci et al.2024)
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 |
What NCT06950385 shows while recruiting
NCT06950385 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
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.
NCT06950385 names 20 study sites across 15 states, led by Florida, Ohio, Pennsylvania.
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).
What interventions are being tested in trial NCT06950385?
The interventions under investigation include: Placebo (DRUG), eRapa (encapsulated rapamycin) (DRUG).
Who is sponsoring clinical trial NCT06950385?
This trial is sponsored by Rapamycin Holdings, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06950385's enrollment target sits among peer trials
168 1460th of 2000 higher than 538 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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