Status:
TERMINATED
Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility
Lead Sponsor:
Amgen
Collaborating Sponsors:
Kyowa Kirin Co., Ltd.
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Diagnosis of asthma, and presently has reversibility over pre-bronchodilator forced expiratory volume in 1 second (FEV1) of ≥ 20% at screening
- Percent of predicted FEV1 ≥ 40% and ≤ 80% at screening
- Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent
- Ongoing asthma symptoms with asthma control questionnaire (ACQ) composite score at screening and baseline ≥ 1.5 points
Exclusion
- History of chronic obstructive pulmonary disease (COPD) 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-interleukin-17 (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
Key Trial Info
Start Date :
May 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2015
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT01902290
Start Date
May 22 2013
End Date
May 15 2015
Last Update
September 21 2022
Active Locations (161)
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1
Research Site
Birmingham, Alabama, United States, 35209
2
Research Site
Glendale, Arizona, United States, 85306
3
Research Site
Phoenix, Arizona, United States, 85006
4
Research Site
Scottsdale, Arizona, United States, 85251