a study to evaluate the safety and efficacy of hae1 in subjects with moderate to severe allergic asthma

Conditions: Allergic Asthma

Summary: this is a phase ii, multicenter, randomized, double blind, placebo controlled, multiple-dose study designed to evaluate the efficacy, safety, and tolerability of subcutaneously administered hae1 in subjects 12-75 years old with moderate to severe asthma whose symptoms are inadequately controlled with moderate to high-dose ics and laba.


Eligibility criteria:
inclusion criteria: * signed informed consent form(s) * male and females 12-75 years of age with the diagnosis of allergic asthma for 12 months according to the standards of the american thoracic society * baseline fev1 values ≥ 40% to ≤ 80% of the predicted normal value for the subject * demonstration of ≥ 12% increase in fev1 over baseline value within 30 minutes of taking up to four puffs of albuterol (90 ug/puff) * treatment with ics in doses equivalent to 250-500 ug fluticasone twice daily (bid) for 8 weeks prior to screening and as needed or regular use of bronchodilator therapy * treatment with a stable regimen of 50 ug salmeterol bid or 12 ug formoterol bid for at least 8 weeks prior to screening (with or without other asthma controller medications) * a positive radioallergosorbent test (rast) to one or more of the pertinent perennial or seasonal allergens * total serum ige level ≥ 20 to ≤ 1500 iu/ml and body weight between ≥ 40 and ≤ 150 kg * acceptable medical history and physical examination results * demonstrated ability to use mini-wright peak flow meter for the measurement of peak expiratory flow (pef) and a metered dose inhaler (mdi) for administration of albuterol rescue medication * willingness to complete the daily diary cards * history of smoking of less than 10 pack-years and no smoking for ≥ 12 months * for females of childbearing potential, use an effective method of contraception from screening throughout their duration of study participation (e.g., oral, mechanical, sc, or surgical contraception) * inadequately controlled asthma 4 weeks during the run-in period as demonstrated by either of the following: one or more nighttime awakenings per week or asthma symptoms during the day requiring rescue medication for 2 or more days per week exclusion criteria: * active lung disease other than asthma * asthma exacerbation requiring treatment with the addition of systemic (oral or iv) corticosteroids or an increase in systemic corticosteroids within 1 month prior to screening or during the run-in period * significant change (e.g., 50% change) in dosage of inhaled corticosteroids in daily dose or dosing schedule within 1 month of prior to the screening visit or during the run-in period * significant medical illness other than asthma * treatment with methotrexate, gold salts, cyclosporine, theophyllines, or macrolide antibiotics within 3 months prior to screening or during the run-in period * treatment with hae1 * any treatment with omalizumab * known hypersensitivity to the ingredients of the hae1 formulation, to trial rescue medication (albuterol), or related drugs * history of acute infectious sinusitis or respiratory tract infection within 1 month prior to screening or during the run-in period * aspirin or other nonsteroidal anti-inflammatory drug-related asthma * allergy vaccination therapy \< 3 months of stable maintenance dose prior to screening * treatment with oral or parenteral corticosteroids within 1 month prior to screening or during the run-in period * current treatment with \ -blocker medications (e.g., propranolol) * clinically significant abnormality on 12-lead electrocardiogram (ecg) at screening * abnormal chest x-ray (excluding changes consistent with asthma) within 12 months prior to screening * clinically significant or active systemic disease (e.g., cancer, neoplasia, infection, hematological, renal, hepatic, coronary heart disease or other cardiovascular diseases, or endocrine or gastrointestinal disease) within 3 months of screening or during the run-in period * inability or unwillingness to comply with study procedures and visits (e.g., spirometry, blood draws, subject diary) * history of drug or alcohol abuse * elevated serum ige levels for reasons other than allergy (e.g., parasitic infection, hyperimmunoglobulin e syndrome, wiskott-aldrich syndrome, or bronchopulmonary aspergillosis) * pregnancy or lactation * platelet count ≤ 110,000/mm\^3 or ≤ 110 x 10\^9/l at screening or the qualifying run-in visit * clinically significant laboratory abnormalities, which would limit participation in the study or interfere in the interpretation of study, or affect subject safety, and evaluations at screening or the qualifying run-in visit * treatment with an investigational drug within 1 month of screening or during the run-in period