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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01902290

Run by

Amgen

People needed

421

Starts

2013-05-22

Expected to finish

2015-05-15

Last updated by the study team

2022-09-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Glendale, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Bakersfield, California, United States
• Research Site — Encinitas, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — North Hollywood, California, United States
• Research Site — Orange, California, United States
• Research Site — Palmdale, California, United States
• Research Site — Rolling Hills Estates, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Jose, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Stockton, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Waterbury, Connecticut, United States
• Research Site — Aventura, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Lynn Haven, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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