Policka

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are evaluating the clinical efficacy and safety of OD-07656 in adults with moderately to severely active ulcerative colitis UC. The study also aims to assess whether OD-07656 can improve the benefits of vedolizumab when given after OD-07656 treatment. This Phase 2a study is sponsored by Odyssey Therapeutics and focuses on patients who have had an inadequate response or intolerance to various UC therapies. Participants will receive oral doses of OD-07656 twice daily in one of three dosing regimens, with some groups randomized to different doses. Following the OD-07656 treatment phase, subsequent vedolizumab therapy will be evaluated for its therapeutic effects. The study design includes an open-label part and a randomized part, each assessing treatment safety and efficacy over specified periods. During the study, participants will be monitored through regular assessments including the 3-component Modified Mayo Clinic Score at baseline and after 12 weeks of OD-07656 treatment. Researchers will track treatment-emergent adverse events and treatment discontinuations. Clinical remission rates will be evaluated both after OD-07656 treatment and following vedolizumab therapy up to 50 weeks. The total participation period and detailed monitoring schedules will be managed according to the study protocol.