Overview
The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma.
Study participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.
Eligibility
Inclusion Criteria:
- Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit.
- Participants must have an asthma control questionnaire-6 (ACQ-6) score of ≥1.5 on 2 out of 3 visits before randomization.
- History of 1 severe asthma exacerbation that led to systemic glucocorticoid treatment in the last 12 months prior to screening visit.
Exclusion Criteria:
- Participants are excluded from the study if any of the following criteria apply:
- An established diagnosis of occupational asthma
- Known pre-existing, clinically important lung condition other than asthma, including
but not limited to:
- chronic respiratory infection
- bronchiectasis
- pulmonary fibrosis
- allergic bronchopulmonary aspergillosis
- emphysema
- chronic bronchitis
- eosinophilic granulomatosis with polyangiitis
- chronic obstructive pulmonary disease, and
- other mimics of asthma, that is, vocal cord dysfunction.
- Have a current or recent acute, active infection. For at least 30 days before
screening visit and up to the randomization visit.