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

This study has been terminated.
(The decision to stop the study was due to a lack of observed efficacy in a pre-specified interim analysis. The decision was not related to safety concerns.)
Sponsor:
Collaborators:
Kyowa Hakko Kirin Co., Ltd
AstraZeneca
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01902290
First received: May 22, 2013
Last updated: March 14, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Asthma Biological: Placebo Biological: 210 mg brodalumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Asthma Control Questionnaire [ Time Frame: week 24 ]
    To evaluate the efficacy of brodalumab compared with placebo as measured by the change in asthma control (based on the Asthma Control Questionnaire [ACQ]) from baseline to week 24


Secondary Outcome Measures:
  • asthma exacerbations [ Time Frame: week 24 ]
    To evaluate the effect of brodalumab compared to placebo at week 24 on asthma exacerbations (defined by oral corticosteroid use).


Other Outcome Measures:
  • Daily asthma symptoms as measured by the asthma symptom diary [ Time Frame: week 24 ]
    To evaluate the effect of brodalumab compared to placebo at week 24 on daily asthma symptoms as measured by the asthma symptom diary.

  • Lung function based on pre-bronchodilator FEV1 (forced expiratory volume in one second) [ Time Frame: week 24 ]
    To evaluate the effect of brodalumab compared to placebo at week 24 on lung function based on pre-bronchodilator FEV1 (forced expiratory volume in one second).

  • Rescue short-acting β-agonist (SABA) use [ Time Frame: week 24 ]
    To evaluate the effect of brodalumab compared to placebo at week 24 on rescue short-acting β-agonist (SABA) use.

  • Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: week 24 ]
    To evaluate the effect of brodalumab compared to placebo at week 24 on Asthma Quality of Life Questionnaire (AQLQ).

  • Safety [ Time Frame: week 24 ]
    To evaluate the safety of brodalumab as measured by subject incidence of adverse events.

  • Pharmacokinetics (PK)-AUC [ Time Frame: week 24 ]
    To evaluate the pharmacokinetics (PK) of brodalumab in subjects with asthma using AUC (Area under the Curve).

  • Pharmacokinetics (PK)-Cmax [ Time Frame: week 24 ]
    To evaluate the pharmacokinetics (PK) of brodalumab in subjects with asthma using Cmax (the maximum plasma concentration of brodalumab).

  • Pharmacokinetics (PK)- Tmax [ Time Frame: week 24 ]
    To evaluate the pharmacokinetics (PK) of brodalumab in subjects with asthma using Tmax (the amount of time that brodalumab is present at the maximum concentration in serum)


Enrollment: 421
Study Start Date: May 2013
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Administered by subcutaneous (SC) injections until week 24.
Biological: Placebo
Placebo administered SC
Experimental: 210 mg brodalumab
Administered by subcutaneous (SC) injections until week 24.
Biological: 210 mg brodalumab
210 mg brodalumab administered SC

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01902290

  Show 161 Study Locations
Sponsors and Collaborators
Amgen
Kyowa Hakko Kirin Co., Ltd
AstraZeneca
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01902290     History of Changes
Other Study ID Numbers: 20120141
2012-003351-11 ( EudraCT Number )
Study First Received: May 22, 2013
Last Updated: March 14, 2016

Keywords provided by Amgen:
Inadequately controlled asthma, brodalumab, AMG 827

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bronchodilator Agents
Antibodies, Monoclonal
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 19, 2017