A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults

Exclusion Criteria

• are met, subjects with a FEV1 of ≥ 1.5 L and ≥ 60% on Day -14 will be eligible to undergo a methacholine challenge. If the subject achieves a positive response to this methacholine challenge, then this criterion is met
• 10) Uncontrolled asthma consistent with EPR-3. In the 28 days before screening, subjects should have a history of one or more of the following:
• • Daytime asthma symptoms ≥ 2 days/week
• • Nighttime awakening ≥ 1 night/week
• • Albuterol/salbutamol use ≥ 2 days/week
• 11) An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at Day -28 and at Day 1.
• 12) At least one asthma exacerbation in the 12 months before screening that required intake of systemic corticosteroids after an unscheduled medical encounter or as agreed with a physician based on an asthma action plan that defines when oral steroids can be taken by the subject
• 13) Ability and willingness to complete the follow-up period through Day 323 as required by the protocol.
• Exclusion Criteria
• Any of the following would exclude the subject from participation in the study:
• 1) Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
• 2) Concurrent enrollment in another clinical study
• 3) Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
• 4) Known history of allergy or reaction to any component of the investigational product formulation
• 5) History of anaphylaxis to other biologic therapy
• 6) Lung disease other than asthma (eg, chronic obstructive pulmonary disease [COPD], cystic fibrosis)
• 7) Severe depression as measured by a depression score > 15 on the Hospital Anxiety and Depression Scale (HADS) at either Day-28 or Day 1.
• 8) History of suicidal behavior in the previous 3 years as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) at Day -28.
• 9) Acute illness other than asthma at the screening and randomization visits
• 10) History of an active infection within 28 days before and during the screening period, or evidence of clinically significant active infection, including ongoing chronic infection
• 11) History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; history of recent travel to areas where parasite infestations are endemic within 6 months before screening; or a diagnosis of parasitic infection within 6 months before screening
• 12) Use of immunosuppressive medication (except oral prednisone up to a dose of 20 mg every other day or equivalent [eg, 10 mg a day or 5 mg twice a day] and inhaled and topical corticosteroids) within 28 days before randomization
• 13) Receipt of immunoglobulin or blood products within 28 days before randomization
• 14) Plans to donate blood during the entire study period
• 15) Donated blood or has had a blood transfusion within 28 days before screening
• 16) Receipt of any non-biological study drugs or interventional therapy (including surgical procedures) within 28 days of the first dose of investigational product in this study
• 17) Receipt of any biologicals including MEDI-528 within 5 half-lives before the first dose of investigational product in this study
• 18) History of any known immunodeficiency disorder
• 19) A positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject’s verbal report
• 20) A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject’s verbal report
• 21) A live attenuated vaccination received within 28 days before screening
• 22) History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator
• 23) Breastfeeding or lactating
• 24) History of treatment for alcohol or drug abuse within the past year
• 25) History suggestive of COPD or of tobacco smoking ≥ 10 pack-years
• 26) Evidence of any uncontrolled systemic disease upon physical examination
• 27) History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 1 year before Day 1 or other malignancies treated with apparent success with curative therapy ≥ 5 years before screening
• 28) Any noninfectious disease involving multiple organs (eg, cystic fibrosis, systemic lupus erythematosus, hemophilia, multiple sclerosis, etc.) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
• 29) Individuals who are legally institutionalized