AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma

Study Overview
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Brief Summary
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The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.

Official Title
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A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects With Inadequately Controlled Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: AMG 853
* Drug: AMG 853
* Drug: AMG 853
* Drug: AMG 853
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females 18 to 65 years of age Percent of predicted FEV1 ≥ 50% and ≤ 80% At least 12% reversibility over pre-bronchodilator FEV1 Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent. Ongoing asthma symptoms with ACQ score ≥ 1.5 points Exclusion Criteria: History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma Any uncontrolled, clinically significant systemic disease Respiratory infection within 4 weeks of the screening visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 853<br> | Drug: AMG 853<br>* AMG 853 5 mg (BID)<br>Drug: AMG 853<br>* AMG 853 200 mg (QD)<br>Drug: AMG 853<br>* AMG 853 25 mg (BID)<br>Drug: AMG 853<br>* AMG 853 100 mg (BID)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12. |  | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA) |  | Baseline to Week 12 | 
| Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days) |  | Baseline to Week 12 | 
| Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) |  | Baseline to Week 12 | 
| Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR) |  | Baseline to Week 12 | 
| Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ) |  | Baseline to Week 12 |