Policka

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are evaluating the safety and effectiveness of OD-07656 in adults with moderately to severely active ulcerative colitis (UC). This Phase 2a study also aims to assess whether OD-07656 can improve the benefits of vedolizumab, a standard treatment, when given afterward. Participants must have a confirmed diagnosis of UC and have not responded adequately or tolerated previous UC therapies. Participants will receive OD-07656 as the experimental treatment. After completing treatment with OD-07656, some will receive vedolizumab to evaluate combined therapeutic effects. The study design includes an open-label and randomized approach to assess these treatments in a controlled manner. During the study, researchers will monitor changes in the 3-component modified Mayo Clinic Score to measure disease activity from the start to 12 weeks after treatment. They will also track any treatment-emergent adverse events and reasons for stopping treatment during this period. The trial involves regular assessments to ensure safety and evaluate the ongoing response to therapy over the 12-week timeframe.