Status:
RECRUITING
Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis
Lead Sponsor:
Rapamycin Holdings Inc.
Collaborating Sponsors:
Biodexa Pharmaceuticals
Conditions:
Familial Adenomatous Polyposis (FAP)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 compa...
Detailed Description
This is a Phase 3, multi-site, prospective, randomized, double-blind, placebo-controlled trial of eRapa administered to patients with FAP who are at high risk of disease progression. 168 patients with...
Eligibility Criteria
Inclusion
- Participant must be ≥18 years of age inclusive.
- Participant must have documented FAP, confirmed by adenomatous polyposis coli genotype mutation testing.
- Participant must have at least 1 of the following high-risk features: \>100 polyps but ≤500 polyps in the colon, or ≥10 polyps in the retained rectum/sigmoid or ileal pouch (≥3 mm in size), or Spigelman stage 3 or 4 with at least 1 polyp ≥10 mm to be removed at baseline or on endoscopy performed within 18 months of screening.
- Contraceptive use by participants or participant partners until at at least 12 weeks after stopping study treatment.
- Agree not to donate gametes for the purpose of reproduction until at at least 12 weeks after stopping study treatment.
- Willing to undergo endoscopic evaluation.
Exclusion
- Participant has unresected or incompletely resected high-grade dysplasia or cancer within the duodenum, colon, rectum, or ileal pouch at screening endoscopy.
- Participant has any polyps ≥8 mm in the duodenum, colon, rectum, or ileal pouch remaining after screening endoscopy (polyps ≥8 mm are to be resected during screening endoscopy).
- Participant has had surgery within 6 weeks of the trial.
- Participant has active malignancy or history of malignancy diagnosed within 24 months of first dose of trial intervention.
- Participant has a history of, or currently has, an acquired or primary (congenital) immunodeficiency.
- Participant has active and clinically significant tuberculosis (positive Quantiferon Gold test), bacterial, fungal, or viral infection, including human immunodeficiency virus (HIV).
- Participant has any medical or social condition that, in the opinion of the Investigator, might increase participant risk if enrolled, prevent participant compliance to trial procedures, or present an unacceptable confound to safety or clinical trial data.
Key Trial Info
Start Date :
July 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2031
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06950385
Start Date
July 18 2025
End Date
January 1 2031
Last Update
December 29 2025
Active Locations (24)
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1
City of Hope
Arcadia, California, United States, 91007
2
Yale Cancer Center
New Haven, Connecticut, United States, 06520
3
Georgetown University
Washington D.C., District of Columbia, United States, 20057
4
Digestive & Liver Center of Florida
Orlando, Florida, United States, 32825