Kanoya

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the use of Ilaris canakinumab in patients diagnosed with Schnitzlers syndrome to assess how well it works and how safe it is in real-world clinical settings. This observational study focuses on people who are using canakinumab for the first time to treat this rare condition. The study is sponsored by Novartis Pharmaceuticals and aims to gather detailed information about treatment responses and safety outcomes. Participants in this study will be those starting canakinumab treatment for Schnitzlers syndrome as per the approved indications. The study observes patients over time without changing or assigning treatments, registering all diagnosed patients who receive canakinumab, including those who began treatment before the study contract was finalized. It excludes patients previously treated with canakinumab in a specific prior study or those treated for other related inflammatory syndromes or off-label uses. Throughout the study, researchers will monitor patients clinical responses, including complete or partial improvement rates from the first week up to 48 weeks after starting treatment. They will also track various blood markers such as white blood cell counts, neutrophil counts, C-reactive protein levels, alkaline phosphatase, and immunoglobulin levels at multiple time points. Safety is assessed by recording adverse reactions and serious events throughout the observation period. The total study duration extends up to June 2032, allowing long-term follow-up of participants.