Actively Recruiting
Phase 3b4 Study of Depemokimab Added to Standard Care for Adolescents and Adults with Type 2 Asthma at Risk of Exacerbations
Led by GlaxoSmithKline · Updated on 2026-06-25
456
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults and adolescents aged 12 years or older at consent
- Documented physician diagnosis of asthma for at least 2 years according to guidelines
- History of at least 2 asthma exacerbations in the last 3 years, with at least one in the past year
- Stable treatment with low to medium dose inhaled corticosteroids and long-acting beta2-agonists for at least 3 months
- Female participants not pregnant or breastfeeding and using effective contraception if of childbearing potential
- Capable of giving signed informed consent or assent
- Type 2 high asthma at risk of exacerbations defined by specific blood eosinophil counts and related criteria
You will not qualify if you...
- History of 3 or more asthma exacerbations in the last year
- Use of maintenance oral corticosteroids or high dose inhaled corticosteroids/long-acting beta2-agonists
- Asthma duration longer than 20 years
- Other significant lung conditions besides asthma
- Conditions causing elevated eosinophils other than asthma
- Recent asthma exacerbation within 4 weeks before screening
- Known parasitic infestation within 6 months unless treated
- Known immunodeficiency except due to corticosteroid use for asthma
- Current or recent cancer within 12 months
- Significant uncontrolled health conditions affecting major body systems
- Current diagnosis of vasculitis
- Previous treatment with biologic monoclonal antibodies
- History of alcohol or substance abuse within 2 years
- Current smokers or former smokers with 20 or more pack years and vapers
- Allergy or intolerance to monoclonal antibodies or depemokimab ingredients
- Pregnant or breastfeeding
- Known non-adherence to asthma controller medications or physician recommendations
- Significant abnormal lab findings at screening
- Liver safety exclusions including elevated liver enzymes or unstable liver disease
- Cardiac safety exclusions including abnormal ECG findings related to QTc interval
- Changes in asthma medication during run-in period except for exacerbation treatment
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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