Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults with Inadequately Controlled Asthma with High Bronchodilator Reversibility
Study Details
The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.
Protocol Summary
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24
Timeframe: Baseline and week 24
Asthma Exacerbation Rate
Timeframe: Baseline to week 24
Change From Baseline in ACQ Composite Score at Week 24 in ICS+LABA Subpopulation
Timeframe: Baseline and week 24
Asthma Exacerbation Rate in ICS+LABA Subpopulation
Timeframe: Baseline to week 24
Change from Baseline in Daily Asthma Symptom Score (7-day Average Score)
Timeframe: Baseline and week 24
Change from Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Timeframe: Baseline and week 24
Change from Baseline in Daily Rescue Short-acting Beta-agonist Use
Timeframe: Baseline and week 24
Time to First Asthma Exacerbation
Timeframe: From first dose of study drug to week 24
Number of Participants who Experienced an Asthma Exacerbation
Timeframe: Baseline to week 24
Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score
Timeframe: Baseline and week 24
Change from Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR)
Timeframe: Baseline and week 24
Change from Baseline in Variation of Peak Flow
Timeframe: Baseline and week 24
Proportion of Asthma Symptom-free Days in 4-weeks Intervals Over the Treatment Period
Timeframe: Baseline (the 4 weeks prior to first dose) and 4-week intervals up to week 24
Serum Brodalumab Concentration
Timeframe: Day 1 and weeks 1, 2, 4, 8, 12, 16, and 22 at predose, week 2 + 3 days, week 22 + 3, 7, 10, and 14 days