Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
United States150 participantsStarted 2025-06-03
Plain-language summary
Asthma is a chronic condition marked by narrowed and swollen airways due to inflammation leading to recurring symptoms that can vary and worsen unpredictably.\\xa0The purpose of this study is to assess how depemokimab, a monoclonal antibody, affects the structure and function of the lungs in asthmatic participants with type 2 inflammation, characterized by an eosinophilic phenotype.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Documented clinical diagnosis of asthma for greater than or equal to (\>=) 2 years as per the National Heart, Lung, and Blood Institute guidelines (NHLBI, 2020) or GINA guidelines (GINA, 2024), or joint guidance from the British Thoracic Society, National Institute for Health and Care Excellence, and Scottish Intercollegiate Guidelines Network \[NICE, 2024\] along with the following: an eosinophilic phenotype as evidenced by a blood eosinophil count of \>=300 cells/microliters (mcL) at screening or a documented history of blood eosinophil count \>=300 cells/mcL within 3 months prior to screening; Exhaled nitric oxide (FeNO) measure of \>=25 parts per billion (ppb) recorded at screening; and a previously confirmed history of \>= 2 exacerbations requiring treatment with systemic corticosteroid (SCS; intramuscular \[IM\], intravenous \[IV\], or oral), in the 12 months prior to screening, despite the use of medium to high dose Inhaled corticosteroids (ICS)
* Uncontrolled asthma indicated by Astha Control Questionnaire-5 (ACQ-5) greater than (\>) 1.5 recorded at screening
* Persistent airflow obstruction as indicated by pre-bronchodilator Forced Expiration Volume in 1 second (FEV1) less than (\<) 80 percentage (%) predicted (GLI 2012) and recorded at screening
* A well-documented requirement for regular treatment with medium or high dose ICS (in the 12 months prior to screening with or without maintenance oral corticosteroids \[OCS\])
* Current treatment wit…
What they're measuring
1
Mean Change from Baseline in Total Mucus Plug Volume Measured at Total Lung Capacity (TLC) at Week 26