Hexham

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.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are evaluating the efficacy and safety of a single dose of NTLA-2001 compared to a placebo in people with transthyretin amyloidosis with cardiomyopathy (ATTR-CM). This phase 3, multinational, multicenter, double-blind, placebo-controlled study aims to better understand how this treatment affects cardiovascular health in participants with this condition. Participants will be randomly assigned to receive one intravenous infusion of either NTLA-2001 at a dose of 55 mg or a placebo consisting of normal saline (0.9% NaCl). The study plans to include approximately 1200 participants. The treatment is given only once during the study period. During the study, participants will be monitored for cardiovascular mortality and cardiovascular events over a period estimated to last from at least 18 months up to about 5 years, depending on event rates. Assessments will include clinical evaluations, blood tests such as NT-proBNP levels, and safety monitoring. Researchers will track how well participants tolerate the treatment and measure its effects on their heart condition throughout this extended follow-up.