Trial · NCT06950385
Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis
NCT06950385, Phase 3, Recruiting, Rapamycin Holdings Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis. Trials, record NCT06950385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06950385
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis
- NCT number
- NCT06950385
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 168 participants, estimated
- Lead sponsor
- Rapamycin Holdings Inc.
- Conditions
- Familial Adenomatous Polyposis (FAP)
- Interventions
- eRapa (encapsulated rapamycin), Placebo
- First posted
- 2025-04-30
- Last updated
- 2026-06-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) in high-risk patients with FAP treated with eRapa versus placebo. | 3 years | * 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) |
| Secondary | The safety and tolerability of eRapa in patients with FAP | 3 years | -Frequency of all grades (as per the Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 5.0) treatment-emergent adverse events (TEAEs) in participants receiving eRapa; * Frequency of Grade 3 and higher (as per the CTCAE v5.0) TEAEs in participants receiving eRapa * Percentage of participants discontinuing eRapa treatment due to adverse drug reactions (ADRs) |
| Secondary | The effect of eRapa treatment on GI polyposis in patients with FAP | 3 years | * Percent change from baseline in the PB (i.e., the sum of the diameters of all polyps \>3 mm) at 6, 12, 18, 24, 30, and 36 months as observed by surveillance endoscopy Note: The total PB will be based on polyps observed in the upper GI tract (duodenum) and the lower GI tract (colon, retained rectum/sigmoid or pouch) * Percent change from baseline in the PB in the upper GI tract (duodenum) at 6, 12, 18, 24, 30, and 36 months as observed by upper endoscopy * Percent change from baseline in the PB in the lower GI tract (colon, retained rectum/ sigmoid or pouch) at 6, 12, 18, 24, 30, and 36 months as observed by lower endoscopy |
| Secondary | The effect of eRapa treatment on Spigelman stage score in patients with FAP | 3 years | Change from baseline in Spigelman stage score at 6, 12, 18, 24, 30, and 36 months |
| Secondary | The effect of eRapa treatment on quality-of-life measures, assessed by the 5 level EuroQoL-5 Dimension (EQ-5D-5L) | 3 years | -Change from baseline in EQ-5D-5L score at 6, 12, 18, 24, 30, and 36 months; |
| Secondary | Determine the immunomodulating effect of eRapa treatment in patients with FAP | 3 years | • Change from baseline in T cell phenotypes and function at 12, 24, and 36 months |
| Secondary | The effect of eRapa treatment on quality-of-life measures, assessed by EORTC-30 | 3 years | -Change from baseline in EORTC-30 score at 6, 12, 18, 24, 30, and 36 months; |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06950385
GET https://conductscience.org/api/trials/v1/NCT06950385/registered