Orchard Park

Researchers are evaluating the effects of two different methods of giving pegloticase, a drug for uncontrolled gout, combined with methotrexate (MTX). This Phase 3 trial compares pegloticase given as an 18 mg injection under the skin every two weeks with pegloticase given as an 8 mg intravenous (IV) infusion every two weeks, both alongside weekly oral MTX. The main goal is to see which method better maintains normalized serum uric acid levels below 6 mg/dL for at least 80% of the time during the sixth month of treatment. Participants will be randomly assigned to receive pegloticase either by subcutaneous injection or intravenous infusion every two weeks, along with weekly oral doses of methotrexate. Both groups will be treated over several months while closely monitored. The study is double-blind, meaning neither participants nor researchers know which treatment is being given to maintain unbiased results. During the trial, participants will undergo regular assessments to monitor their serum uric acid levels and overall response to treatment, especially focusing on weeks 20 through 24 (Month 6). Safety and efficacy will be tracked throughout the study, including how well participants tolerate the treatments and any side effects. The study's main measure is the proportion of participants who achieve a sustained uric acid response during Month 6.

Researchers are investigating the effect of olpasiran compared to a placebo in reducing the risk of coronary heart disease death, heart attack, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have elevated lipoprotein(a) levels. This Phase 3 study focuses on participants aged 50 years and older with multiple cardiovascular risk factors or evidence of atherosclerosis. The goal is to understand whether olpasiran can help prevent these serious heart-related events in this population. Participants will receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind and randomized, meaning neither participants nor researchers will know who receives the active drug or placebo. The intervention period and follow-up will continue for up to approximately 6.2 years to monitor the occurrence of major cardiovascular events. During the study, participants will be closely monitored for outcomes including time to coronary heart disease death, myocardial infarction, or urgent coronary revascularization. Regular assessments will be performed to track cardiovascular health and safety. The long observation period aims to ensure thorough evaluation of olpasiran's impact on preventing first major cardiovascular events in people with elevated lipoprotein(a).

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab given every 4 weeks or every 12 weeks compared to placebo, all combined with standard-of-care therapy, in adults with active lupus nephritis. This phase 3 trial focuses on participants with specific classes of lupus nephritis confirmed by recent kidney biopsy and meeting established diagnostic criteria. Participants will receive either ianalumab every 4 weeks, ianalumab every 12 weeks, or a placebo, all given by subcutaneous injection alongside standard lupus nephritis treatment. Standard-of-care includes induction therapy with high-dose corticosteroids and mycophenolic acid (MPA). Treatment schedules and doses are carefully monitored throughout the study. Participants will be involved in regular assessments including kidney function tests, urine protein measurements, and clinical evaluations up to week 72 to monitor treatment response and safety. The primary outcome is the frequency of participants achieving stable complete renal response by week 72. Safety and tolerability are also closely tracked during the trial period.

Researchers are evaluating the Shield blood test as a screening tool for colorectal cancer (CRC) in people aged 45 to 81 who are at average risk for CRC. This study aims to assess how well the Shield test performs during a second round of testing, using colonoscopy as the standard comparison. Colorectal cancer is a common and serious disease, especially in older adults, and early detection through screening can reduce mortality by catching cancer at earlier, more treatable stages. Participants will undergo the Shield blood test as part of their standard care. The study focuses on average-risk individuals who do not have symptoms or high-risk factors for CRC. The performance of the Shield test will be monitored over a period of 33 to 42 months after enrollment to evaluate its effectiveness compared to colonoscopy results. During the study, participants will follow study procedures and standard care assessments. Researchers will measure the performance of the Shield test in detecting colorectal cancer and its precursors during the second testing interval. This includes ongoing monitoring and data collection to understand the test's accuracy and reliability in a real-world setting, with a total follow-up period extending beyond two and a half years.