RecruitingAsthma
Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: GlaxoSmithKline
You may qualify if…
- ✓ 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 with at least one additional asthma controller medication, besides ICS, for at least 3 months \[for example, Long-acting Beta 2 agonists \[LABA\], Long-acting muscarinic antagonists \[LAMA\], leukotriene receptor antagonist (LTRA), or theophylline\]
- ✓ Male Participants: No additional requirements for male participants
- ✓ A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: is a participant of non-childbearing potential (PONCBP) or is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency,
- ✓ A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention
You may not qualify if…
- ✕ Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic obstructive pulmonary disease \[COPD\] other than asthma) are excluded
- ✕ Participants with other conditions that could lead to elevated eosinophils such as hyper eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis
- ✕ Participants who developed an exacerbation within 4 weeks before screening
- ✕ Participants with a known, pre-existing parasitic infestation within 6 months prior to screening unless treated and evidenced to have been resolved
- ✕ A known immunodeficiency (e.g. human immunodeficiency virus HIV), other than that explained by the use of corticosteroids (CSs) taken as therapy for asthma
- ✕ A current malignancy or previous history of cancer in remission for less than 12 months prior to screening
- ✕ Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic, hematologic abnormalities or any other system abnormalities that are uncontrolled with standard treatment
- ✕ Participants with current diagnosis of vasculitis
Where it's recruiting
Florida
Brooksville · Plantation
Kansas
Kansas City
Missouri
St Louis
New Jersey
New Brunswick
New York
New York
Pennsylvania
DuBois · Philadelphia
Texas
McKinney
Source: ClinicalTrials.gov · NCT06979323 · last updated 2026-04-23