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

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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

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

Trial contacts and locations

161

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Data sourced from clinicaltrials.gov

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