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Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis

Study acronym: SERENTA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 26 → 29 locationsv12
  2. Site details revised at 3 of 26 sitesv11
  3. Study sites: 24 to 26v10
  4. Site details revised at 5 of 24 sitesv9
  5. Site details revised at 3 of 24 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 18 to 24v7
  2. Study sites: 7 to 18v6
  3. Study sites: 5 to 7v5
  4. Study sites: 3 to 5v4
  5. Study sites: 1 to 3
    • Start date changed from estimate of Jul 2025 to Jul 18, 2025
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06950385
Lead Sponsor Rapamycin Holdings Inc.
Collaborators: Biodexa Pharmaceuticals
Conditions
(from sponsor)		 Familial Adenomatous Polyposis (FAP)
Related terms Adenomatous Polyposis Coli, Polyps
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov