Eligibility Criteria
Diagnosed FAP
With or without family history.
18 years or older
Have at least 1 of the following high-risk features:
- participants who have intact colons and have >100 but <=500 polyps,
- participants who have retained rectum/sigmoid or ileal-pouch-anal anastomosis and have >=10 polyps that are >=3mm in diameter, or
- participants who have history of duodenal polyposis Spigelman stage of 3 or 4 with >=1 duodenal polyp >=10mm that has been removed within 18 months of screening.
The Serenta trial is a Phase 3 clinical trial for people diagnosed with familial adenomatous polyposis (FAP). The purpose of this trial is to test an experimental treatment, eRapa, to evaluate its ability to improve clinical outcomes in FAP patients vs placebo (inactive substance).
This trial is double-blind, which means you, your trial doctor and the trial team will not know which trial intervention you will be receiving.
Trial participants may be able to join the trial if they meet the following requirements:
Interested in the Serenta FAP Trial?
Contact a study clinic near you or visit clinicaltrials.gov.
Frequently Asked Questions
How can I participate in the Serenta trial?
You can talk to a trial doctor to find out if you may qualify for the trial. Contact us at info@serentatrial.com.
What if I don’t live near a research center?
Please contact us to explore further options; we are committed to supporting participants with travel logistics and expenses necessary to participate in the trial.
How frequently do I need to visit the site/research center?
The trial will run for up to 24 months from the time of recruitment of the final patient into the trial. The anticipated average time in the trial is likely to be about 33 months. During that time, you will visit the clinic on initiation and every 3 months thereafter until the conclusion of the trial or the occurrence of a predefined event.
Will I be able to participate in other clinical trials while enrolled in the Serenta trial?
Participants in the Serenta trial are restricted from participating in other studies in which they receive an investigational drug. Participation in an observational trial that does not require interventional treatment (e.g., another trial drug from a different trial) is permitted.
Important Notice on Personal Information
To protect your privacy and comply with data protection regulations, please do not disclose any personal information (such as your full name, contact details, or medical history) through this website. We do not collect or process personal data via this platform. If you are interested in participating in the clinical trial, please contact your healthcare provider or the clinical trial site directly, where your information can be handled securely and confidentially in accordance with applicable privacy laws.
Your privacy and the confidentiality of your data are our highest priority. Any personal information related to the clinical trial will only be collected through official channels and with your informed consent as outlined in the clinical trial’s privacy policy.