Study of Efficacy and Safety of Brodalumab Compared With Placebo in Inadequately Controlled Asthma Subjects With High Bronchodilator Reversibility



Status:Terminated
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:May 2013
End Date:May 2015

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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator Reversibility

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.


Inclusion Criteria:

- Diagnosis of asthma, and presently has reversibility over pre-bronchodilator FEV1 of
≥ 20% at screening

- Percent of predicted FEV1 ≥ 40% and ≤ 80% at screening

- ICS ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent

- Ongoing asthma symptoms with ACQ composite score at screening and baseline ≥ 1.5
points

Exclusion Criteria:

- History of chronic obstructive pulmonary disease or other chronic pulmonary condition
other than asthma

- History of allergic bronchopulmonary aspergillosis

- Respiratory infection within 4 weeks of screening or 1 week of baseline visit

- Subject has known history of Crohn's disease Subject has any other significant
concurrent medical condition of laboratory abnormalities, as defined in the study
protocol

- Subject has previously used any anti-IL17 biologic therapy

- Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled
in the study

- Female subject is unwilling to use highly effective methods of birth control unless 2
years post-menopausal or surgically sterile

- Subject has severe depression measured by Personal Health Questionnaire Depression
Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide
Severity Rating Scale (e-CSSRS)

- Subject has a history or evidence of psychiatric disorder or substance abuse
considered by the Investigator to pose a risk to subject safety
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