Shanwei

Researchers are evaluating nipocalimab compared to a placebo in adults with moderate to severe systemic lupus erythematosus SLE, a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This Phase 3 study aims to understand how well nipocalimab works in treating SLE symptoms and disease activity. Participants will receive either nipocalimab or a placebo alongside standard care treatments during a double-blind treatment period lasting up to 52 weeks. After this period, eligible participants from both groups may enter an open-label long-term extension phase to continue nipocalimab treatment until Week 156 or until discontinuation. Throughout the study, participants will undergo assessments including measurement of disease activity, joint pain, fatigue, and flare status. Researchers will monitor responses such as the SLE Responder Index at Week 52, and track safety and treatment adherence. The total participation duration may extend up to approximately three years including the extension phase.

People with end stage kidney disease ESKD who require dialysis face a much higher risk of cardiovascular disease compared to the general population, with cardiac issues causing 58% of deaths in this group. However, while aspirin is known to reduce cardiovascular problems in the general population, there is limited evidence about its effects in dialysis patients. The ASPIrin to Reduce Event in Dialysis ASPIRED trial aims to study whether taking low-dose aspirin can safely improve cardiovascular outcomes in people with ESKD receiving dialysis. This study is a multi-center, double-blind, randomized controlled trial that will compare daily low-dose aspirin 100 mg to a placebo pill in patients undergoing dialysis. The trial uses an existing dialysis registry platform to screen, recruit, and collect data during routine clinical care, minimizing participant burden and study costs. Randomization is managed through a secure web-based system, and follow-up visits occur every six months as part of regular clinic visits. The trial is expected to last approximately five years and includes oversight by an independent safety and monitoring board. Participants will be involved in regular six-monthly clinic visits where their health will be monitored as part of their usual dialysis care. Researchers will track the occurrence of major cardiovascular events, including heart attacks, strokes, vascular complications, and deaths, throughout the study period. Data will be collected from routine clinical procedures and the dialysis registry to evaluate outcomes. Safety and efficacy will be closely monitored, and the study will follow participants for up to five years to assess the long-term effects of aspirin use in this population.

Researchers are studying the safety and effectiveness of two combination treatments for women with HER2-positive metastatic or recurrent breast cancer. This trial focuses on first-line treatments using Inetetamab combined either with Pertuzumab or with Pyrotinib plus chemotherapy. The goal is to find better clinical benefits and offer new targeted treatment options for this condition. Participants receive Inetetamab intravenously every three weeks with a loading dose followed by maintenance doses. One group also receives Pertuzumab intravenously every three weeks, while the other group takes Pyrotinib orally daily. Chemotherapy is chosen by the doctor. Treatments continue until disease progression, unacceptable side effects, or study end. The study is randomized and open-label, comparing these two regimens. During the study, participants will have tumor assessments every six weeks to measure overall response and progression-free survival, lasting up to two years. Safety is monitored through adverse event reporting and heart function tests. The trial also tracks overall survival for up to about 48 months. Participants will be followed closely with clinical evaluations, imaging, and laboratory tests throughout their involvement.