Phase 3b4 Study of Depemokimab Added to Standard Care for Adolescents and Adults with Type 2 Asthma at Risk of Exacerbations

What this Trial Is About

Researchers are evaluating depemokimab as an additional treatment for adults and adolescents aged 12 and older with Type 2 asthma who are at risk of exacerbations. The study compares depemokimab combined with standard care against a placebo with standard care to assess its impact on reducing asthma flare-ups and improving lung function over time. This Phase 3b4 trial aims to provide insights into the safety and effectiveness of early intervention with depemokimab. Participants are randomly assigned to receive either depemokimab or a placebo alongside their usual asthma treatments. The study is double-blind and involves multiple centers, lasting up to 156 weeks 3 years. During this period, participants will continue their standard asthma care while receiving the study drug or placebo. The trial monitors the rate of asthma exacerbations and other clinical outcomes to determine the impact of depemokimab compared to placebo. Throughout the study, participants will attend scheduled visits for assessments including lung function tests, asthma control and quality of life questionnaires, and safety evaluations. Researchers will track the annual rate of asthma exacerbations as the main outcome and observe changes in clinical remission, lung function, and asthma symptoms over two years. Safety monitoring will continue during the trial to ensure participant well-being, with the total participation lasting up to three years.

A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma