Phase II Study to Evaluate the Efficacy of AMG 317

Study Overview
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Brief Summary
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A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom 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 317 in Subjects With Moderate to Severe Asthma

Conditions
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Asthma

Intervention / Treatment
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* Biological: AMG 317 75 mg
* Biological: AMG 317 150 mg
* Biological: AMG 317 300 mg
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females 18 to 65 years of age at the time of screening Baseline percent of predicted FEV1 ≥ 50% to ≤ 80% at screening At least 12% reversibility over baseline FEV1 with beta agonist inhalation, which can be demonstrated in the office or documented by medical record within the past 12 months Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent. Stable ICS dose for ≥ 30 days before screening and dose expected to remain stable during treatment with investigational agent. Must have used ICS for at least the last 3 consecutive months before screening If receiving allergen immunotherapy, a stable dose for > 3 months before screening and anticipated to remain stable for the duration of the study Positive to skin prick or RAST Ongoing asthma symptoms with ACQ score at screening and baseline ≥ 1.5 points Nonsmoker or ex-smoker with < 10 pack-years (eg, 1 pack per day for 10 years) who stopped ≥ 1 year ago Exclusion Criteria: Acute asthma exacerbation requiring emergency room (ER) treatment or hospitalization within 3 months History of endotracheal intubation for asthma-related exacerbation within 3 years of screening Respiratory illness within 4 weeks of screening History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma Received long-acting beta agonist, theophylline, inhaled anticholinergics, oral beta 2 agonists, or cromolyn therapeutics within 1 week of first run-in visit. Leukotriene antagonists within 2 weeks before first run-in visit Oral or parenteral corticosteroids within 6 weeks before first run-in visit Live/attenuated vaccinations within 4 weeks of screening or during the study Any uncontrolled, clinically significant systemic disease (eg, chronic renal failure, uncontrolled hypertension, liver disease)

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 317 75 mg<br>75 subjects | Biological: AMG 317 75 mg<br>* 75 mg SC weekly injection<br>|
| Placebo Comparator: Placebo Arm<br>75 subjects | Biological: Placebo<br>* Placebo SC once weekly injection<br>|
| Experimental: AMG 317 300 mg<br>75 subjects | Biological: AMG 317 300 mg<br>* 300 mg weekly SC injection<br>|
| Experimental: AMG 317 150 mg<br>75 subjects | Biological: AMG 317 150 mg<br>* 150 mg SC once weekly injection<br>* Other names: AMG 317 300 mg dose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in frequency of rescue beta agonist use during week 12 |  | 12 weeks | 
| Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation) |  | 12 weeks | 
| Change in pre and post bronchodilator FEV1 at week 12 from baseline |  | 12 weeks | 
| Number of asthma symptom-free days |  | 16 weeks | 
| Change from baseline in daily asthma symptoms during week 12 |  | 12 weeks | 
| Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs |  | 16 weeks | 
| Change in AQLQ score at week 12 from baseline |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Allergy, IL-13, IL-4, IL-4R