Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis
Rapamycin Holdings Inc. · with Biodexa Pharmaceuticals · NCT06950385
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 168
- US sites recruiting
- 18
- Study start
- July 18, 2025
- Record last updated
- June 2, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: eRapa (encapsulated rapamycin); Placebo
Conditions: Familial Adenomatous Polyposis (FAP)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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 Criteria
- 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.
Recruiting US locations
City of Hope
Arcadia, CA 91007
Site contact: Gregory Idos · 626-218-2570 · gidos@coh.org
Yale Cancer Center
New Haven, CT 06520
Site contact: Edgar Benitez · 2033936591 · edgar.benitez@yale.edu
Georgetown University
Washington D.C., DC 20057
Site contact: Priyanth Kanth · 202-444-1431 · priyanka.kanth@medstar.net
Digestive & Liver Center of Florida
Orlando, FL 32825
Site contact: Alisa Del Vecchio · 407-490-4526 · alisa.delvecchio@dlcfl.com
Cleveland Clinic Florida
Weston, FL 33331
Site contact: Michael Nicolas · 954-659-6213 · nicolam4@ccf.org
University of Chicago
Chicago, IL 60615
Site contact: Sonia Kupfer · 773-702-6140 · cancerclinicaltrials@bsd.uchicago.edu
University of Kansas Medical Center
Kansas City, KS 66160
Site contact: Llana Abella · 913-584-0533 · labella@kumc.edu
Johns Hopkins University
Baltimore, MD 21205
Site contact: Lisa Datta · 410-614-1982 · erapastudy@live.johnshopkins.edu
Dana Farber Cancer Institute
Boston, MA 02115
Site contact: Samantha Kuney · 617-582-9095 · ColonScreening@dfci.harvard.edu
University of Michigan
Ann Arbor, MI 48109
Site contact: Erika Koeppe · 734-998-1274 · eskoeppe@med.umich.edu
Department of Surgery, Section of Colon Rectal and Surgery
St Louis, MO 63110
Site contact: Asima Badic · 314- 362-2646 · asimabadic@wustl.edu
Cleveland Clinic
Cleveland, OH 44195
Site contact: Lindsey Reardon · (216) 444-7493 · Reardol3@ccf.org
Ohio State University
Columbus, OH 43210
Site contact: Kebire Gofar · 614-600-2113 · kebire.gofar@osumc.edu
Geisinger Medical Center
Danville, PA 17822
Site contact: Kay Reiner · 570-214-5421 · kmreiner1@geisinger.edu
University of Pittsburgh Medical Center
Pittsburgh, PA 15213
Site contact: Sara Booz · 412-864-7516 · boozs@upmc.edu
The University of Texas MD Anderson Cancer Center
Houston, TX 77030
Site contact: Annie Lincoln · 919-923-4430 · aglincoln@mdanderson.org
Benaroya Research Institute at Virginia Mason
Seattle, WA 98101
Site contact: Alicia Reyes · (206)-341-1450 · mariaalicia.reyes@commonspirit.org
University of Washington - Fred Hutchinson
Seattle, WA 98195
Site contact: Brian Forester · (206) 685-1179 · foerstb@uw.edu
Study contacts (from the official record)
- Vice President Clinical Operations · XXX-XXX-XXXX · jim.kostka@biodexapharma.com