The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.
The study details include:
Study treatment: randomized to receive either GB-0895 or placebo administered every 6 months over 52 weeks.
Visit frequency: every 1-2 months after the first month.
Adults and adolescents ≥ 12 and ≤ 80 years of age.
Documented physician diagnosis of asthma for ≥ 2 years.
Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1 with no change in ICS or controller(s) for at least three months.
Subjects must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1.
Subjects who experience a clinically significant asthma exacerbation within 12 weeks before the Screening Visit or during the run-in period and require a change in asthma maintenance therapy.
Other concurrent respiratory disease other than asthma, including (but not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, tuberculosis, diagnosis of chronic pulmonary disease (including but not limited to emphysema and/or chronic bronchitis), or a history of lung cancer.
Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis).
Any cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could affect subject safety, influence study findings or interpretation, or impede completion of the study.
Parallel
GB-0895
DrugStudy Drug
Placebo
DrugPlacebo
To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma.
The annual exacerbation rate is based on clinically significant (CS) exacerbations reported by the investigator in the electronic case (eCRF) over 52 weeks for subjects on GB-0895 as compared to placebo.
To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma and baseline eosinophils (EOS) < 300 cells/µL.
The annual exacerbation rate is based on CS exacerbations reported by the investigator in the eCRF over 52 weeks for subjects with baseline EOS \< 300 cells/ µL on GB-0895 as compared to placebo.
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
The change from baseline in pre-BD FEV1 for subjects on GB-0895 as compared to placebo at week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Change from baseline in Asthma Quality of Life Questionnaire AQLQ(S)12+ score
The change from baseline on AQLQ(S)12+ score for subjects on GB-0895 as compared to placebo at week 52. The AQLQ(S)12+ is a 32-question assessment with questions related to symptoms, activity limitations, emotional function, and environmental stimuli. Questions are scored on a 7-point scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean to all questions.
Change from baseline in Asthma Control Questionnaire (ACQ-6) score
The change from baseline on ACQ-6 score for subjects on GB-0895 as compared to placebo at week 52. The ACQ-6 is a 6-question questionnaire that assesses asthma symptoms (e.g., activity limitation, shortness of breath, wheezing etc.). Questions are scored on a 6-point scale, where 0 corresponds to totally controlled asthma and 6 corresponds to severely uncontrolled asthma.
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