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

INTERVENTION: Product Name: AMG 853 Product Code: AMG 853 Pharmaceutical Form: Coated tablet INN or Proposed INN: AMG 853 CAS Number: n/a Current Sponsor code: AMG 853 Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: AMG 853 Product Code: AMG 853 Pharmaceutical Form: Coated tablet INN or Proposed INN: AMG 853 CAS Number: n/a Current Sponsor code: AMG 853 Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: AMG 853 Product Code: AMG 853 Pharmaceutical Form: Coated tablet INN or Proposed INN: AMG 853 CAS Number: n/a Current Sponsor code: AMG 853 Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: AMG 853 Product Code: AMG 853 Pharmaceutical Form: Coated tablet INN or Proposed INN: AMG 853 CAS Number: n/a Current Sponsor code: AMG 853 Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use CONDITION: Inadequately Controlled Asthma ; MedDRA version: 12.0 Level: LLT Classification code 10003553 Term: Asthma PRIMARY OUTCOME: Main Objective: The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from; baseline to week 12.; ; Primary end point(s): Efficacy Endpoint:; ; • Change in ACQ scores from baseline to week 12; Secondary Objective: Evaluate the efficacy of AMG 853 as measured by:; • Pre‐ and post‐bronchodilator forced expiratory volume in 1 second (FEV1),; • AM and PM peak expiratory flow rate (PEFR),; • Use of rescue short‐acting ß‐agonist (SABA),; • Daily symptom score (aggregate/night and individual symptoms; and symptom free; days),; • Asthma quality of life questionnaire (AQLQ).; ; Exploratory Objectives:; ; Evaluate the efficacy of AMG 853 as measured by:; ; • Asthma exacerbations,; • Patient global rating of change,; • Total serum Immunoglobulin E (IgE),; • Exhaled nitric oxide,; • Sputum eosinophils (substudy),; • Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ),; • Sleep scale from Medical Outcomes Study (Sleep‐MOS).; ; Assess the pharmacokinetics of AMG 853.; Investigate novel circulating biomarkers in the asthma setting.; ; Safety Objectives:; ; Evaluate the safety of AMG 853 as measured by:; ; • Adverse events,; • Changes in electrocardiogram (ECG),; • Laboratory profiles,; • Vital signs.; INCLUSION CRITERIA: Males or females 18 to 65 years of age at the time of screening Percent of predicted FEV1 = 50% and = 80% at screening and baseline visits At least 12% reversibility over pre‐bronchodilator FEV1 with SABA inhalation (up to 8 puffs) or nebulized equivalent (up to 2 treatments with 2.5 mg albuterol), demonstrated in the office during screening Inhaled corticosteroid (ICS) = 200 and = 1000 µg/day fluticasone or equivalent. Stable ICS dose for = 30 days before screening and must have used ICS for at least the last 3 consecutive months prior to screening. The ICS dose is expected to remain the same from screening through the end of study. Ongoing asthma symptoms with ACQ score = 1.5 points, at screening and baseline If receiving allergen immunotherapy, a stable dose for > 3 months before screening and anticipated to remain stable for the duration of the study Nonsmoker or ex‐smoker with < 10 pack‐years (e