Asthma MedDRA version: 17.1 Level: LLT Classification code 10003561 Term: Asthma, unspecified System Organ Class: 100000004855
Conditions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men or women = 18 to = 75 years of age at the time of screening - Diagnosis of asthma, and presently has reversibility over pre-bronchodilator FEV1 of = 20% at screening and = 15% at baseline, demonstrated in the office with SABA inhalation (up to 8 puffs) or nebulized equivalent (up to 2 treatments with 2.5 mg albuterol/salbutamol) - Percent of predicted FEV1 = 40% and = 80% at screening and baseline visits - ICS = 200 and = 1000/µg/day fluticasone powder or equivalent. Stable ICS dose for = 30 days before screening. Must have used ICS for at least the last 3 consecutive months prior to screening - Ongoing asthma symptoms with ACQ composite score at screening and baseline = 1.5 points - At least 1 asthma exacerbation in the year before screening - Nonsmoker or ex-smoker with =65 years) yes F.1.3.1 Number of subjects for this age range 66
Exclusion criteria
Exclusion criteria: - History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma - Any, systemic disease considered by the investigator to be clinically significant and uncontrolled or unstable (eg, diabetes, liver disease, renal failure, congestive heart failure, coronary artery disease, myocardial infarction or unstable angina within 12 months prior to screening, angina pectoris within 12 months before screening). -Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia Suicide Severity Rating Scale (eC-SSRS) at screening or at baseline. -Subject has a history or evidence of a psychiatric disorder or substance abuse that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. -Subject has severe depression based on a total score of = 15 on the Patient Health Questionnaire-8 (PHQ-8) at screening or baseline (note: subjects with a total score of 10-14 on the PHQ-8 should referred to a mental health professional). For full detail, please refer to section 4.2 of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 at week 24 in subjects with inadequately controlled asthma and high reversibility despite standard of care.;Secondary Objective: Key Secondary Objectives: To evaluate the effect of brodalumab compared to placebo at week 24 on: • asthma exacerbations (event rate defined as the number of events per subject year) • ACQ in inhaled corticosteroid (ICS)+long acting ß-agonist (LABA) strata • asthma exacerbations (event rate) in ICS+LABA strata;Primary end point(s): Change in ACQ composite score from baseline at week 24 ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary: • number of asthma exacerbations (defined by use of oral corticosteroids) from baseline to week 24 • change in ACQ from baseline at week 24 in ICS+LABA strata • number of asthma exacerbations from baseline to week 24 in ICS+LABA strata;Timepoint(s) of evaluation of this end point: • number of asthma exacerbations (defined by use of oral corticosteroids) from baseline to week 24 • change in ACQ from baseline at week 24 in ICS+LABA strata • number of asthma exacerbations from baseline to week 24 in ICS+LABA strata Full details can be found in table 1 "schedule of Assessments in the protocol" | — |
Countries
Australia, Canada, France, Germany, Greece, Ireland, Italy, New Zealand, Poland, Russian Federation, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed