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

Amgen

Status and phase: Terminated; Phase 2

Conditions: Asthma

Treatments: Biological: Brodalumab; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01902290

20120141

2012-003351-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 421 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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421 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo administered by subcutaneous injection on day 1, week 1, week 2 and every 2 weeks thereafter for 24 weeks.

Treatment:

Biological: Placebo

Brodalumab 210 mg

Experimental group

Description:

Participants received 210 mg brodalumab administered by subcutaneous injection on day 1, week 1, week 2, and every 2 weeks thereafter for 24 weeks.

Treatment:

Biological: Brodalumab