A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma

Condition studied

Severe uncontrolled asthma

Investigational medicinal product(s)

Eligibility

Primary endpoint

Annualized asthma exacerbation rate (AAER) of clinically significant exacerbations over 52 weeks, defined as exacerbations requiring systemic corticosteroids (oral, intravenous [IV], or intramuscular) and/or hospitalization or emergency department visits requiring systemic corticosteroids

Endpoint detail

• AAER over 52 weeks • Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 52 • Change from baseline in Asthma Quality of Life Questionnaire (AQLQ(S)12+) score at Week 52, • Change from baseline in Asthma Control Questionnaire (ACQ-6) score at Week 52 • Time to first clinically significant exacerbation from randomization, • Change from baseline in weekly mean daily Asthma Daytime Symptom Diary (ADSD) score at Week 52 • Change from baseline in weekly mean daily Asthma Nighttime Symptom Diary (ANSD) score at Week 52