Phase 3 trial of eRapa in patients with familial adenomatous polyposis (FAP)

You may be able to join if

• Participant must be ≥18 years of age inclusive, at the time of signing the informed consent.
• Participant must have documented FAP, confirmed by APC genotype mutation testing or a clear family history of FAP
• 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.
• Male and/or female assigned at birth, inclusive of all gender identities. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male participants are eligible to participate if they agree to the following during the trial intervention period and for at least 12 weeks after the last dose of trial intervention: • Refrain from donating sperm • Be abstinent from intercourse where pregnancy can occur (abstinent on a long term and persistent basis) and agree to remain abstinent, OR • Must agree to use contraception/barrier as detailed below: o agree to use an external condom; with a CBP partner, agree to use of an additional highly effective contraceptive method with a failure rate of <1% per year as described in Appendix 4 when having sexual intercourse with a partner able to give birth who is not currently pregnant; agree to use an external condom when engaging in any activity that allows for passage of ejaculate to another person b. Female participants are eligible to participate if not pregnant or breastfeeding, and 1 of the following conditions applies: • Is of nonchildbearing potential as defined in Appendix 4, OR • Is of CBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, as described in Appendix 4 during the trial intervention period and for at least 12 weeks after thelast dose of trial intervention, and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of trial intervention. • A CBP participant must have a negative highly sensitive pregnancy test (serum at screening, urine or serum at baseline) as required by local regulations) within 24 hours before the first dose of trial intervention, see Section 8.3.4. o If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. • Additional requirements for pregnancy testing during and after trial intervention are located in Section 8.3.4. • The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity where pregnancy can occur to decrease the risk for inclusion of a participant with an early undetected pregnancy. . All female partiicpants must agree to an effective method of contraception until one full menstrual cycle has been completed after last dose of trial treatment.
• Signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
• Participant must be willing and able to safely undergo routine endoscopic evaluation