Kishiwada

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

Researchers are evaluating the effects of three different dosing schedules of povorcitinib on lung function in adults with moderately to severely uncontrolled asthma. This Phase 2, randomized, double-blind, placebo-controlled study aims to assess both the safety and efficacy of povorcitinib in improving respiratory outcomes for this patient group. Participants have a history of asthma treatment with medium- to high-dose ICS-LABA therapy and meet specific lung function criteria before enrollment. Participants will receive one of three povorcitinib dosing regimens or a placebo while continuing their background ICS-LABA therapy. The study includes multiple treatment arms to compare the effects of different doses. The intervention period lasts 24 weeks, during which pulmonary function and other health measures will be monitored. During the study, participants will undergo regular assessments, including lung function tests measuring pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1) at baseline and week 24. Researchers will also monitor safety and collect data on asthma exacerbations and symptom control. The total participation time covers the treatment duration and follow-up evaluations to assess changes in pulmonary function and overall health status.

This research aims to evaluate the safety and effects of the study medicine PF-07328948 for adults with heart failure. It focuses on how this medicine works compared to a placebo in people who are already using standard heart failure treatments that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. The trial is a Phase 2 study designed to better understand if PF-07328948 is safe and effective for managing heart failure symptoms and improving patients' health. Participants will be randomly assigned to receive either placebo tablets or one of three doses of PF-07328948 (low, medium, or high dose). All medications are taken once daily by mouth for 36 weeks. The treatment period is followed by ongoing study visits to monitor participants. The study involves 15 visits over about 48 weeks, with 10 visits at the study site and 5 visits conducted remotely by phone. During the study, researchers will assess participants at the start and after 36 weeks by measuring clinical events, changes in the six-minute walk test distance, and changes in heart failure symptoms using the Kansas City Cardiomyopathy Questionnaire. Safety and treatment effects will be closely monitored through these visits and assessments throughout the study period.

Researchers are evaluating the safety and effectiveness of surgical aortic valve replacement (SAVR) compared to transcatheter aortic valve replacement (TAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk. This prospective, randomized, controlled, multi-center study aims to determine if SAVR is not inferior to TAVR in terms of death from any cause, stroke, and rehospitalization related to valve procedures within one year after surgery. Participants will be randomly assigned to receive either SAVR or TAVR using commercially available surgical and transcatheter bioprosthetic valves. The study includes follow-up visits at hospital discharge, 30 days after the procedure, and then annually for up to 10 years to monitor outcomes and safety. Both procedures involve valve replacement but differ in their surgical approach. During the study, participants will undergo assessments to track mortality, stroke events, and hospital readmissions related to valve or procedure complications. Researchers will collect clinical data and monitor participants regularly over the long-term follow-up period to evaluate the combined primary endpoint at one year post-procedure and observe ongoing safety and effectiveness.

Researchers are evaluating the safety, tolerability, and how the body responds to the drug BMS-986435/MYK-224 in adults with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF), a condition where the heart's pumping ability remains normal despite heart failure symptoms. This Phase 2A study aims to better understand the drug's effects and levels in the body in this specific group of heart failure patients. Participants will receive either BMS-986435 or a placebo, each given at specified doses on certain days. The study is designed as a double-blind, randomized, placebo-controlled trial conducted at multiple centers, ensuring unbiased evaluation of the drug's effects. The treatment period lasts approximately 24 weeks. During the study, participants will be closely monitored for any adverse events, including serious side effects and those that might lead to stopping treatment. The primary outcomes include tracking the incidence of these adverse events up to 24 weeks, with safety and tolerability being the main focus. Participants will be adults aged 40 to 85 with stable, symptomatic HFpEF, and the total involvement will cover the treatment and monitoring periods described.