A Phase 1b-2, Multicenter, Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of REC-4881 in Patients with Familial Adenomatous Polyposis (FAP)
Familial adenomatous polyposis (FAP) is an inherited condition that causes hundreds of small growths, called polyps, to develop inside the bowel. Over time, these polyps can turn into cancer if left untreated. This study is testing an experimental capsule called REC-4881. Researchers want to see if REC-4881 is safe and whether it can reduce the number and size of polyps. Some participants may receive a placebo, which looks identical to the study medicine but contains no active ingredients. The trial is split into two parts. The first part checks how the drug travels through the body and bloodstream. The second part measures changes in bowel polyps over several months of treatment. Taking part is completely voluntary, and doctors will closely monitor all participants throughout the trial.
En un coup d'œil
De quoi parle cette étude ?
Familial adenomatous polyposis (FAP) is a rare genetic condition passed down through families. People with FAP develop many small, non-cancerous growths called polyps along the lining of their large bowel and digestive tract. Because these polyps carry a very high risk of turning into bowel cancer over time, patients often need frequent camera checks and major surgery to remove parts of the bowel.
This study looks at a new investigational drug called REC-4881. Scientists have designed this medicine to try to slow down, shrink, or prevent polyps from growing. The trial is exploring whether taking REC-4881 as a daily capsule is safe, what side effects it might cause, and how the body absorbs and clears the medicine.
Finding medicines that can manage polyps could provide new options alongside surgery. By taking part, participants help doctors learn whether medical treatments can safely control FAP and reduce the burden of repeated surgical procedures in the future.
Points clés
- The trial tests an experimental medicine called REC-4881 for adults with FAP.
- The main goal is to find out if the drug is safe and if it can reduce bowel polyps.
- Participants take capsules by mouth and attend regular clinic visits for monitoring.
- Some participants may receive an inactive dummy pill (placebo).
- Taking part is voluntary, and you can withdraw at any point.
Qui peut être éligible ?
This trial is open to adults aged 18 and over who have been diagnosed with familial adenomatous polyposis (FAP). Both men and women can join.
To take part, participants must have visible polyps that can be measured during standard camera checks of the bowel, such as an endoscopy or colonoscopy.
People with certain other serious health issues, recent major surgery, or those who are pregnant or breastfeeding may not be able to join. The study team will review each person's full medical history and current medications to make sure taking part is safe for them.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- I am aged 18 or older.
- I have a confirmed diagnosis of familial adenomatous polyposis (FAP).
- I currently have bowel polyps that can be monitored by doctors.
- I am willing to attend regular hospital appointments and have camera checks (endoscopies).
- I am not currently pregnant or breastfeeding.
En quoi consiste la participation ?
Taking part involves taking study capsules by mouth on a regular schedule. Some people will receive REC-4881, while others may receive a placebo (dummy capsule) to compare the results fairly. You will need to attend regular clinic visits over a period of roughly 9 to 10 months (up to 37 weeks or more). During visits, the medical team will carry out health checks, take blood samples to see how much medicine is in your body, and perform camera tests (endoscopies) to count and measure your polyps. After finishing treatment, there will be a follow-up visit to check on your overall recovery and wellbeing.
Risques et avantages potentiels
Emplacements (3)
- —Non vérifiéPays-Bas
- —Non vérifiéAllemagne
- —Non vérifiéEspagne
Questions fréquentes
What is REC-4881?
REC-4881 is an experimental capsule being developed to treat FAP by targeting the pathways that cause bowel polyps to grow.
Qu'est-ce qu'un placebo ?
A placebo is a dummy pill that looks and feels just like the real medicine but contains no active drug. It helps researchers prove whether the real drug actually works.
Will I have to pay for the study treatment?
No. The trial medicine, tests, and medical visits related to the study are provided free of charge.
How often will my polyps be checked?
Doctors will examine your polyps using a camera test at the start of the study and at set intervals, such as 12, 25, and 37 weeks.
Puis-je quitter l'étude si je change d'avis ?
Yes. You have the right to leave the clinical trial at any time, for any reason, and your normal healthcare will continue as usual.
Comment en savoir plus
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Discussion
Discussion communautaire
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