Evaluating Galvokimig Versus Placebo in Adults with Non-Cystic Fibrosis Bronchiectasis Over 24 to 52 Weeks

What this Trial Is About

Researchers are evaluating the effects of Galvokimig compared to a placebo in adults with non-cystic fibrosis bronchiectasis NCFB. The study aims to assess how these treatments impact the time until the first pulmonary exacerbation, a worsening of lung symptoms, in participants with this condition. This is a Phase 2 clinical trial focused on treatment safety and effectiveness. Participants will be randomly assigned to one of four groups three groups receiving different doses of Galvokimig and one group receiving a matching placebo. Galvokimig is given as a solution for injection. The treatment period ranges from 24 to 52 weeks, during which participants receive the assigned dose or placebo. The study design is parallel and quadruple-masked, meaning neither participants nor researchers know who receives which treatment. Throughout the study, participants will undergo assessments including lung function tests post bronchodilator FEV1, quality of life questionnaires specific to bronchiectasis symptoms, and monitoring for adverse events. Researchers will track the time to first moderate or severe lung exacerbation and the rate of exacerbations over the study period. Safety evaluations continue up to 60 weeks, and participant involvement includes regular visits and evaluations to monitor health, treatment effects, and side effects.

A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis