Vacoas Phoenix

Researchers are conducting a phase 2, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohns Disease CD. The main goal is to compare different doses of SAR441566 against placebo in these participants. The study is sponsored by Sanofi and aims to understand how well SAR441566 works in treating CD. Participants will be randomly assigned to receive one of three different doses of SAR441566 or a matching placebo. The treatment is given orally as tablets. The study lasts up to 59 weeks, including a 4-week screening period, followed by a 52-week main treatment phase. This main phase has a 12-week double-blind induction period and a 40-week maintenance period. Eligible participants may also enter an open-label extension lasting up to 40 weeks, but the combined duration of the maintenance and open-label periods cannot exceed 40 weeks. Throughout the study, participants will visit regularly for assessments including endoscopy, stool frequency and abdominal pain scoring, and blood tests to measure drug levels and safety. Researchers will measure outcomes such as endoscopic response at week 12 and clinical remission using various indices. Safety will be monitored by tracking adverse events up to week 52. After treatment, a 2-week follow-up occurs for those not continuing in the long-term safety study, with total participant involvement lasting up to 59 weeks.