The MODIFY Study: A Phase 3b/4 Randomized, Double-blind, Placebo-controlled, Multi-centre Study Evaluating the Impact of Early Intervention With Depemokimab on Exacerbation Rate, Clinical Remission, Lung Function Decline, and Safety in Adults and Adolescents With at Risk Type 2 Asthma, Conducted up to 156 Weeks
GlaxoSmithKline
Summary
The aim of this study is to evaluate the efficacy of depemokimab administered as an adjunctive therapy, in participants with Type 2 asthma at risk of exacerbations compared to the guideline recommended standard of care (SoC).
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults and adolescents \>=12 years of age, at the time of signing the informed consent/assent. For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be \>=18 years of age. * Participants must have a documented physician diagnosis of asthma for \>=2 years that meets the National Heart, Lung, and Blood Institute, National Institute for Health and Care Excellence or Global Initiative for Asthma guidelines * Have previously confirmed history of at least 2 exacerbations over the last 3 y…