Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
ConditionAsthma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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])
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Depemokimab
Biological/VaccineDepemokimab will be administered.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: DepemokimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Change from Baseline in Total Mucus Plug Volume Measured at Total Lung Capacity (TLC) at Week 26
Mean change from baseline in total mucus plug volume measured at TLC at Week 26 will be assessed.
Time frame
From Baseline up to Week 26Secondary outcomes
1
Mean Change from Baseline in Airway Wall Thickness Measured at TLC at Week 52
Mean change from baseline in airway wall thickness measured at TLC at Week 52 will be assessed.
Time frame
From Baseline up to Week 522
Mean Change from Baseline in Airway Wall Thickness Measured at TLC at Week 26
Mean change from baseline in airway wall thickness measured at TLC at Week 26 will be assessed.
Time frame
From Baseline up to Week 263
Mean Change from Baseline in Total Mucus Plug Volume Measured at TLC at Week 52
Mean change from baseline in total mucus plug volume measured at TLC at Week 52 will be assessed.
Time frame
From Baseline up to Week 524
Mean Change from Baseline at Week 26 for Mucus Segment Score
Mean change from baseline at Week 26 for mucus segment score will be assessed. The airway is divided into segments and each segment is given a score depending on the presence and severity of mucus. The segments are scored individually and then these scores are summed to give a total mucus score. (A mucus segment score between 0 - 4 indicates low levels of mucus production and a mucus segment score of 5 indicates higher levels of mucus production.)
Time frame
From Baseline up to Week 26Sponsors and contacts
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Source ClinicalTrials.gov