Inca

Researchers are evaluating the drug eRapa to see if it can slow down the progression of disease in patients diagnosed with Familial Adenomatous Polyposis (FAP). This Phase 3 trial compares eRapa to a placebo in patients who are considered high risk for disease progression. The study aims to answer if eRapa is effective and safe, how it affects the number of polyps in the gastrointestinal tract, and its impact on quality of life. Participants will be randomly assigned in a 2:1 ratio to receive either 0.5 mg of eRapa or a matching placebo orally once a day every other week. Treatment continues until the disease worsens, the participant stops the trial, or the trial endpoint is reached. Patients will have a baseline endoscopy and follow-up endoscopies every 6 months to monitor disease status. Clinic visits occur every 3 months for check-ups and tests. The trial includes patients with intact colons or those who have had surgery but still have residual polyps. During the study, participants will take their assigned capsules and attend regular clinic visits about every three months for assessments. These include endoscopies, physical exams, and other tests to track disease progression and safety. The main measure of success is progression-free survival over three years. Researchers will also monitor participants' quality of life and any side effects, ensuring ongoing safety and data collection throughout the trial.

Researchers are studying treatment options for de novo stenosis in patients with Crohn's disease, a common complication causing significant illness and often leading to repeated surgery. This trial aims to compare surgical resection with endoscopic treatments, including balloon dilation and self-expanding metal stents, to determine which approach is more effective and safer. The study also explores how these treatments impact patients' quality of life and healthcare costs, as no direct comparisons currently exist. Participants will receive either surgical removal of the affected intestine or endoscopic treatment starting with balloon dilation; if balloon dilation fails, a metal stent may be used. The study focuses on stenoses less than 10 cm in length and includes patients with up to two stenoses. This trial is designed as a randomized comparative study conducted across multiple centers to evaluate these treatment methods. Throughout the one-year follow-up, participants will undergo assessments to monitor their quality of life. Researchers will collect data on symptoms, treatment success, complications, and costs associated with each approach. The study includes endoscopic and radiological tests to confirm stenosis and monitors patient outcomes to better understand the benefits and risks of surgical versus endoscopic treatments in managing Crohn's disease stenosis.