Asthma is a chronic condition marked by narrowed and swollen airways due to inflammation leading to recurring symptoms that can vary and worsen unpredictably. The 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Depemokimab will be administered.
GSK Investigational Site
Plantation, Florida, United States
RECRUITINGMean 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 26
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 52
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 26
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 52
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 26
Mean Change from Baseline at Week 52 for Mucus Segment Score
Mean change from baseline at Week 52 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.)
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Time frame: From Baseline up to Week 52
Mean Change from Baseline in Pre- and Post- Bronchodilator Forced Expiration Volume in 1 second (BD FEV1) at Week 26
Mean change from baseline in Pre- and Post- BD FEV1 at Week 26 will be assessed.
Time frame: From Baseline up to Week 26
Mean Change from Baseline in Pre- and Post-BD FEV1 at Week 52
Mean change from baseline in Pre- and Post-BD FEV1 at Week 52 will be assessed.
Time frame: From Baseline up to Week 52
Number of Participants with Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Time frame: Up to Week 65 (End of Study)
Number of Participants with Serious Adverse Events (SAE)
Any untoward medical occurrence resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, possible drug-induced liver injury or any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent serious outcomes were categorized as SAE. Number of participants who had at least one SAE or non-SAE are presented.
Time frame: Up to Week 65 (End of Study)