Lighthouse Point

Researchers are evaluating the effects of different doses of SAR442970 compared to placebo in adults with moderate to severe Crohn's disease. This phase 2b, randomized, double-blind study aims to assess the safety and effectiveness of SAR442970 in treating this condition. Participants must have had Crohn's disease for at least three months and have shown inadequate response or intolerance to previous standard or advanced therapies. Participants will receive either SAR442970 or placebo through subcutaneous injections during the treatment period, which lasts up to 158 weeks. Eligible participants may continue into an open-label long-term extension phase for up to 104 weeks. The study includes three treatment groups to compare different doses of SAR442970 with placebo. Throughout the study, participants will be closely monitored with various assessments to measure their response to treatment, including the percentage achieving endoscopic response by Week 16. Researchers will also monitor safety and collect data over a total duration of up to 168 weeks. Participants will have regular visits for evaluations, including clinical assessments and adherence to treatment protocols.

This research aims to evaluate the effectiveness of different doses of SAR442970 compared to placebo in adults with moderate to severe Ulcerative Colitis. It is a phase 2b, randomized, double-blind study conducted across multiple centers and countries. The study includes participants who have had active Ulcerative Colitis for at least three months and meet specific disease activity criteria measured by the modified Mayo Score. Participants will receive either SAR442970 or placebo through subcutaneous injections. The treatment period can last up to 158 weeks and includes a long-term open-label extension lasting up to 104 weeks for those who qualify. This design allows for assessment of both short-term and longer-term effects of the study drug. Throughout the study, researchers will monitor participants regularly to assess clinical remission using the modified Mayo Score at Week 16 as the primary outcome. Participants will undergo clinical evaluations, endoscopy, and other assessments to track disease activity and safety. The total study duration can extend up to 168 weeks, ensuring thorough long-term observation and safety monitoring.

Researchers are evaluating the safety and effectiveness of LY4268989 when given together with mirikizumab compared to mirikizumab alone in adults with moderately to severely active ulcerative colitis (UC). This Phase 2 study focuses on adults aged 18 to 80 years who have had UC diagnosed for at least 3 months and have active symptoms confirmed by specific clinical scores and endoscopic evidence. The study aims to assess clinical remission using the Modified Mayo Score at 12 weeks. Participants will receive either LY4268989 by mouth combined with mirikizumab administered first intravenously and then by subcutaneous injection, or mirikizumab alone with a placebo pill. The entire study treatment period will last about 104 weeks, with up to 21 visits planned for monitoring. Treatment schedules and dosing are designed to compare the combination therapy to mirikizumab alone. During the study, participants will undergo regular assessments including clinical evaluations, endoscopy, and monitoring of symptoms and safety. Researchers will track the percentage of participants achieving clinical remission by week 12 using the Modified Mayo Score. Participants will be followed closely throughout the study duration, which totals approximately 118 weeks from start to finish, including treatment and follow-up visits.