eRapa for Adenomatous Polyposis

(SERENTA Trial)

Overseen By Amy Ellenberger

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Rapamycin Holdings Inc.

Disqualifiers: Cancer, Immunodeficiency, Infections, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Up to 3 years

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Vance Sohn, MD

Principal Investigator

LumaBridge

Are You a Good Fit for This Trial?

This trial is for individuals with Familial Adenomatous Polyposis (FAP), confirmed by genetic testing. Participants must have a specific number of polyps in their colon or rectum, or advanced polyposis, and be willing to undergo regular endoscopic evaluations. They should agree not to donate gametes during and up to 12 weeks post-treatment, and use contraception.

Inclusion Criteria

I will use birth control during and for 12 weeks after the study.

I agree not to donate eggs or sperm for 12 weeks after my treatment ends.

I have FAP confirmed by a specific genetic test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive eRapa or placebo once per day every other week until disease progression, withdrawal, or death

Up to 3 years

Clinic visits every 3 months, endoscopy every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• eRapa

Trial Overview The trial is examining if eRapa can slow down FAP progression compared to a placebo. Patients will take the drug or placebo every other week until disease progression, withdrawal from the study, or death. They'll visit the clinic quarterly for check-ups and have biannual endoscopies.

How Is the Trial Designed?

Group I: eRapa Experimental Treatment 1 Intervention

0.5 mg eRapa once a day (QD) every other week

Group II: Placebo Placebo Group 1 Intervention

Placebo once a day (QD) every other week

Who Is Running the Clinical Trial?

Rapamycin Holdings Inc.

Lead Sponsor

Trials

1

Recruited

30+

Biodexa Pharmaceuticals

Industry Sponsor

Trials

2

Recruited

30+