Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.

• Drug: MEDI-563
  Subcutaneous repeating dose
• Drug: Placebo
  Subcutaneous repeating dose

• Experimental: MEDI-563 - Arm A
  Intervention: Drug: MEDI-563
• Experimental: MEDI-563 - Arm B
  Intervention: Drug: MEDI-563
• Experimental: MEDI-563 - Arm C
  Intervention: Drug: MEDI-563
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• Age 18 through 75 years at the time of screening.
• Adequate contraception from screening through end of trial.
• Weight of > 45 kg but ≤ 150 kg (> 100 lb but ≤ 330 lb).
• History of physician-diagnosed asthma for at least 12 months prior to screening.
• Physician prescribed daily use of medium-dose or high-dose ICS plus LABA for at least 12 months prior to screening.
• Willingness to switch to an ICS/LABA combination product.
• Dose of other asthma controller medications must be stable for at least 30 days prior to screening.
• At least 2 documented asthma exacerbations in the 12 months prior to screening that required use of a systemic corticosteroid burst.
• For subjects 65 years of age or older, a chest x-ray (CXR) or chest computed tomography (CT) that is normal for an asthmatic population.
• Ability and willingness to complete the study to Week 66, and if needed to Week 92.

Exclusion Criteria:

• Known history of allergy or reaction to any component of the investigational product formulation.
• History of anaphylaxis to any biologic therapy.
• Unexplained diarrhea within 30 days prior to screening or diagnosis of helminth parasitic infestation within 6 months prior to screening.
• Use of immunosuppressive medication within 3 months prior to screening. Chronic oral prednisone or equivalent up to 10 mg daily or 20 mg every other day for asthma is allowed.
• Oral corticosteroid burst or short-acting systemic corticosteroid within 30 days prior to screening or during the screening/run-in period.
• Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to the screening or during the screening/run-in period.
• Receipt of immunoglobulin or blood products within 30 days prior to screening.
• Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to screening, whichever is longer.
• Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to screening, whichever is longer.
• Previously received MEDI-563.
• Any clinically relevant abnormal findings in physical examination.
• Past history of clinically significant cardiac disease or any electrocardiogram (ECG) abnormality.
• Breastfeeding or lactating women.
• History of alcohol or drug abuse within 12 months prior to screening.
• History of any known primary immunodeficiency disorder.
• Positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll.
• A positive human immunodeficiency virus (HIV) test or subject taking antiretroviral medications.
• History of cigarette smoking ≥ 10 pack-years or smoking within 12 months prior to screening.
• Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma.
• History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 12 months prior to screening or other malignancies treated with apparent success with curative therapy ≥ 5 years prior to screening.
• Stable dose of allergy vaccination regimen for less than 30 days prior to screening.
• Subjects unable to demonstrate acceptable inhaler and peak flow meter techniques.