NCT06950385 Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis
| NCT ID | NCT06950385 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Rapamycin Holdings Inc. |
| Condition | Familial Adenomatous Polyposis (FAP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2025-07-18 |
| Primary Completion | 2030-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 168 participants in total. It began in 2025-07-18 with a primary completion date of 2030-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: 1. Participant must be ≥18 years of age inclusive. 2. Participant must have documented FAP, confirmed by adenomatous polyposis coli genotype mutation testing. 3. 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. 4. Contraceptive use by participants or participant partners until at at least 12 weeks after stopping study treatment. 5. Agree not to donate gametes for the purpose of reproduction until at at least 12 weeks after stopping study treatment. 6. Willing to undergo endoscopic evaluation. Exclusion Criteria: 1. Participant has unresected or incompletely resected high-grade dysplasia or cancer within the duodenum, colon, rectum, or ileal pouch at screening endoscopy. 2. 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). 3. Participant has had surgery within 6 weeks of the trial. 4. Participant has active malignancy or history of malignancy diagnosed within 24 months of first dose of trial intervention. 5. Participant has a history of, or currently has, an acquired or primary (congenital) immunodeficiency. 6. Participant has active and clinically significant tuberculosis (positive Quantiferon Gold test), bacterial, fungal, or viral infection, including human immunodeficiency virus (HIV). 7. 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.
Contact & Investigator
Gary Shangold, MD
STUDY DIRECTOR
Biodexa
Frequently Asked Questions
Who can join the NCT06950385 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Familial Adenomatous Polyposis (FAP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06950385 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 168 participants.
Is NCT06950385 currently recruiting?
Yes, NCT06950385 is actively recruiting participants. Contact the research team at jim.kostka@biodexapharma.com for enrollment information.
Where is the NCT06950385 trial being conducted?
This trial is being conducted at Arcadia, United States, New Haven, United States, Washington D.C., United States, Orlando, United States and 11 additional locations.
Who is sponsoring the NCT06950385 clinical trial?
NCT06950385 is sponsored by Rapamycin Holdings Inc.. The principal investigator is Gary Shangold, MD at Biodexa. The trial plans to enroll 168 participants.