Orchard Park

Researchers are evaluating the effectiveness of pegloticase administered by two different methodssubcutaneous under the skin injection versus intravenous into a vein infusioneach combined with methotrexate MTX in participants who have uncontrolled gout. The main goal is to compare how well these two treatment methods maintain normal serum uric acid levels over a six-month period. This Phase 3 trial is designed as a double-blind, randomized controlled study to provide reliable information on treatment responses.

Researchers are evaluating the effects of YB-101 on thyroid function in adults with Graves Disease. The study aims to assess how safe and well tolerated YB-101 is, as well as how it is distributed in the body. This Phase 2 trial includes participants with a documented diagnosis of Graves Disease confirmed by thyroid-stimulating hormone receptor antibodies. The study has two parts Part 1 is a blinded treatment period and Part 2 is a double-blinded treatment period. Participants will receive either YB-101 or a placebo through subcutaneous injections over a 24-week period. Those who participate in Part 1 are not eligible to participate in Part 2. The treatments and placebo are administered similarly in both parts. Participants will attend between 34 to 39 in-clinic visits over approximately 40 weeks depending on their assigned part. Researchers will monitor side effects, safety, and thyroid hormone levels including free triiodothyronine FT3, free thyroxine FT4, and thyroid-stimulating hormone TSH. They will also evaluate the proportion of participants who normalize these hormones and stop anti-thyroid drugs. The study includes safety assessments up to Day 169 and ongoing monitoring throughout the treatment period.

Researchers are evaluating olpasiran, compared to a placebo, to see how it affects the risk of coronary heart disease death, heart attacks, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have high levels of lipoproteina. This Phase 3 study focuses on participants aged 50 to 105 years with multiple cardiovascular risk factors or evidence of atherosclerosis. Participants will be randomly assigned to receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind, so neither participants nor researchers know who receives the active drug or placebo. Treatments and evaluations will continue for up to approximately 6.2 years. Throughout the study, participants will be monitored for heart-related events such as heart attacks, cardiovascular death, strokes, and coronary revascularizations. Researchers will also measure changes in lipoproteina levels at baseline and at Week 48, along with tracking adverse events. The total participation duration can extend up to about 6.2 years, with ongoing assessments to evaluate the treatments effect over time.

This research investigates the long-term efficacy and safety of ianalumab in adults with lupus nephritis who have completed previous treatment in the SIRIUS-LN core study. It evaluates two groups patients who achieved a kidney response and stopped treatment, and those who continue or start open-label ianalumab due to incomplete response or prior open-label treatment. The study aims to understand sustained remission, relapse, and treatment effects over up to six years. Participants are assigned to one of two groups based on their response status at Week 140 of the core study. Those who responded well enter a treatment-withdrawal group and stop study medication while maintaining standard care, with the option to restart ianalumab if kidney flares occur. Others will receive open-label ianalumab 300 mg during the extension. This design allows observation of outcomes both on and off the study drug. During the extension, participants are monitored for kidney flare-ups, need for increased immunosuppressive medications, and safety events including adverse reactions. Blood samples will be collected to measure drug levels and antibodies. The study lasts up to six years, enabling long-term assessment of treatment durability and safety. Participants continue regular assessments and follow-up visits as determined by their clinical status.

This research aims to evaluate the effectiveness and safety of LUPKYNIS combined with belimumab, obinutuzumab, or anifrolumab in adults with lupus nephritis LN. The study focuses on how well these combinations induce a rapid kidney response in patients diagnosed with LN, a condition affecting kidney health. It is a phase 4 clinical trial sponsored by Aurinia Pharmaceuticals Inc. that assesses treatment approaches for this condition. Participants will receive LUPKYNIS along with one of the biologic agents belimumab, obinutuzumab, or anifrolumab. In addition, all patients will be treated with a mycophenolic acid analog MPAA, such as mycophenolate mofetil or mycophenolic acid, and corticosteroids like prednisone or an equivalent. The biologic treatment schedules vary depending on the specific drug, with some patients already receiving treatment before the study starts or beginning it at the start of the trial. During the study, participants will be monitored for kidney response over 24 weeks, including complete and partial renal responses. Researchers will assess safety by tracking treatment-emergent adverse events up to 28 weeks. Other assessments include measuring changes in kidney-related antibodies and complement levels at baseline, 12 weeks, and 24 weeks. The total participation duration extends to about 28 weeks, during which various evaluations, laboratory tests, and safety monitoring will occur to understand treatment effects and patient outcomes.

This research aims to evaluate the Shield blood tests performance for colorectal cancer CRC screening in people aged 45 to 81 who are at average risk for CRC. The study focuses on assessing the test during a second round of screening, using colonoscopy as the reference standard. CRC is a common and serious disease, especially affecting older adults and certain minority groups, with early detection being key to improving outcomes. Participants will undergo the Shield blood test as part of their routine standard care, and their results will be compared to colonoscopy findings. This study is observational and collects real-world evidence over a period of 33 to 42 months after enrollment to assess how well the Shield test performs in detecting CRC or its precursors during the second screening interval. Participants will be involved in scheduled study procedures and standard care assessments, with data collected on the tests accuracy and effectiveness over time. The main outcome measured is the performance of the Shield test during the second testing period. The study will continue until December 2030, monitoring participants to gather long-term information about CRC screening efficacy in an average-risk population.