Lynwood

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the recommended dosing regimen of loncastuximab tesirine in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) who have moderate or severe liver impairment. This phase 1b open-label study aims to understand how the drug behaves in the body and its safety in participants with varying levels of liver function. Participants receive loncastuximab tesirine through an intravenous infusion. The study includes groups with normal liver function, moderate hepatic impairment, and severe hepatic impairment. The dosing and safety are monitored closely to determine the best approach for those with liver issues. During the study, researchers track the number of participants experiencing dose-limiting toxicities within the first 21 days of treatment cycles, each lasting 21 days. Participants undergo regular evaluations, including physical assessments and lab tests, to monitor liver function, lymphoma status, and overall health. Safety and pharmacokinetics are observed to guide dosing recommendations.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are evaluating the long-term safety of nivolumab monotherapy, including its use with combinations and other cancer treatments, in patients with various types of cancer. This Phase 2 study focuses on patients who have previously participated in Bristol-Myers Squibb (BMS) sponsored trials involving nivolumab and other cancer therapies. The goal is to gather information on safety over an extended period following treatment. Participants may receive nivolumab alone or alongside other cancer drugs such as ipilimumab, cabozantinib, trametinib, relatlimab, capecitabine, bevacizumab, and others. Each drug is given at specified doses on designated days according to the study protocol. Treatment continuation or rechallenge is based on the participant's status from their prior parent study, including treatment holds after lasting responses or eligibility for restarting treatment. During the study, participants will be closely monitored for adverse events, including general, drug-related, serious, immune-mediated, and select adverse effects, as well as any deaths, from the start of treatment until 135 days after stopping treatment. Safety assessments and clinical evaluations will be conducted regularly to track these outcomes and ensure participant well-being throughout the trial.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.