Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06950385 | Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis | PHASE3 | RECRUITING | 168 | — | — | Jul 18, 2025 | Jan 1, 2031 | Mar 17, 2026 | 26 | United States, Denmark +4 |
* 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) * Retained rectum/sigmoid or pouch (≥10 polyps ≥3 mm in size at baseline) * Duodenum (Stage 3/4 and at least 1 polyp ≥10 mm removed in last 18 months)
| Arm | Type | Description |
|---|---|---|
| eRapa | EXPERIMENTAL | 0.5 mg eRapa once a day (QD) every other week |
| Placebo | PLACEBO_COMPARATOR | Placebo once a day (QD) every other week |
| Name | Type | Description |
|---|---|---|
| eRapa (encapsulated rapamycin) | DRUG | 0.5 mg capsules for oral use; white opaque capsule filled with off-white powder; Trial intervention will be provided in 28-count round high-density polyethylene bottles with a polypropylene child-resistant screw cap and foil induction seal. |
| Placebo | DRUG | Capsules in 28-count round high-density polyethylene bottles with a polypropylene child-resistant screw cap and foil induction seal. |
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 ≥...