Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenously Administered MEDI-563, A Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, on Asthma Control Following Acute Exacerbations in Adults
Brief Summary: The study will evaluate the effect of two intravenous dose regimens of benralizumab (MEDI-563) on the proportion of adult subjects with asthma exacerbations who required an urgent healthcare visit for treatment of an acute asthma exacerbation.


Options:
A: Inclusion Criteria:

* Meet criteria for the diagnosis of allergic asthma
* Diagnosis of asthma ≥ 6 months
* Currently treated with only intermittent short-acting inhaled β-adrenergic agonists
* Body weight between 40-120 kg
* Normal chest X-ray within 2 years of screening

Exclusion Criteria:

* Require daily controller medication for asthma
* History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to MILR1444A (e.g., monoclonal antibodies, polyclonal gamma globulin)
* Documented medical history of anaphylaxis
* Immunotherapy currently or within the past 3 months prior to screening
* Lung disease other than mild allergic asthma
* Previous treatment with other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer
* Pregnant or lactating
* Significant concurrent medical illness other than asthma
* Clinically significant abnormality on ECG at the screening visit
* Smoked in the previous 6 months or have a history of smoking more than 10 pack-years
* History of helminthic infection
B: Inclusion Criteria:

* Signed Informed Consent Form and an informed assent, if applicable
* Be between the ages of 12 to 75 years
* Have had a history of moderate to severe asthma for at least one year prior to screening
* Have had treatment with a stable regimen of of salmeterol 50 µg twice a day (BID) or formoterol 12 µg BID for at least 8 weeks prior to screening
* Have had treatment with a stable regimen of high-dose inhaled corticosteroids (ICS) for at least 8 weeks prior to screening
* Have inadequately controlled asthma
* Have had at least one asthma exacerbation requiring systemic corticosteroid rescue in the 12 months prior to the screening visit while receiving treatment with high-dose ICS
* Have less than 10 pack-years smoking history
* Have a positive skin test for or a positive, in vitro response to one relevant perennial aeroallergen documented within the 12 months prior to screening
* If a subject has not had a positive skin test or in vitro reactivity in the 12 months prior to screening, the subject must demonstrate a positive response to at least one relevant perennial aeroallergen in a skin or in vitro test prior to randomization
* Female subjects of childbearing potential must use an effective method of contraception from screening through their duration of participation in the study
* For the collection of additional blood samples for future research (optional), provide signed consent and an informed assent, if applicable.

Exclusion Criteria:

* Have had an asthma exacerbation requiring intubation within 12 months prior to screening
* Have active lung disease other than asthma
* Have had an asthma exacerbation requiring treatment with the addition of systemic (oral or intravenous) corticosteroids or an increase in systemic corticosteroids within 30 days prior to screening
* Require chronic immunosuppressive therapy including cyclosporine, methotrexate, etc.
* Have significant medical illness other than asthma
* Have taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics, within 3 months prior to screening
* Have taken other investigational drugs within 30 days prior to screening
* Have been treated with Xolair within the 12 months prior to screening
* Have a history of drug or alcohol abuse that, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study
* Have elevated serum IgE levels for reasons other than allergy
* Are pregnant or lactating
C: Inclusion Criteria:

* Physician diagnosis of asthma for greater than or equal to 3 years and a diagnosis of severe persistent asthma forgreater than or equal to 1 year prior to screening
* Continuous treatment with high dose Inhaled corticosteroids (ICS) and long acting beta-agonist for at least 3 months prior to screening
* Have evidence of at least 1 of the following in the 5 years prior to screening or during screening, reversible airway obstruction greater than or equal to 12 percentage change in forced expiratory volume in 1 second (FEV1) postbronchodilator; Diurnal variation in peak expiratory flow rate (PEFR) greater than or equal to 30 percentage change) and airway hyperresponsiveness
* Estimated frequency of symptoms on more than one-third of days for at least 3 months prior to screening (eg, wheezing, breathlessness, chest tightness, cough, nocturnal awakening) despite treatment with high dose ICS and long-acting β2-agonist (LABA), with or without continuous oral corticosteroids
* Score of greater than or equal to 2 points on the asthma control questionnaire at screening.

Exclusion Criteria:

* Diagnosis of chronic obstructive pulmoanry disease (COPD), cystic fibrosis, or other significant respiratory disorder
* Worsening of asthma symptoms that required treatment with an addition or increase in oral corticosteroids dose (steroid burst) in the 4-week period prior to the screening visit
* Life-threatening asthma attack requiring cardiopulmonary support (eg, intubation) in the 6-month period prior to screening
* Have ever used alkylating agents (eg, chlorambucil or cyclophosphamide)
* Concomitant diagnosis or any history of congestive heart failure (CHF), including medically controlled CHF.
D: Inclusion Criteria:

* Male or female subjects aged 18 to 60 years at the time of the administration of investigational product
* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the US only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
* Physician-diagnosed asthma with a duration of greater than or equal to (\>=) 2 years by medical chart or subject report
* Had an asthma exacerbation requiring urgent care in the year prior to screening
* Meets National Heart, Lung, and Blood Institute (NHLBI) for persistent asthma in the 3 months prior to the current urgent healthcare visit
* Current asthma exacerbation that must have lasted \>= 2 hours prior to arrival to the urgent healthcare setting
* Requires at least 2 treatments of inhaled bronchodilators for the current asthma exacerbation in the urgent healthcare setting or within the emergency medical system (EMS) for \>= 1 hour
* Shows an FEV1 or PEF of not more than 70 percent (%) predicted after 1 hour of treatment of the current asthma exacerbation
* Women of child-bearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years post-menopausal, must have used 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner, or sterile sexual partner) from screening through the end of the study (Day 84; Cessation of birth control after this point should be discussed with a responsible physician)
* Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide or abstinence) and must use such precautions from Day 0 through Day 84
* Otherwise healthy by medical history and physical examination
* A chest x-ray that is normal for an asthmatic population and excludes alternative diagnosis per the investigation
* Ability to complete the follow-up period until Day 168 as required by protocol
* The investigator has determined that the subject is clinically stable and the FEV1, is \>= 30% predicted prior to receiving investigational product on Day 0.

Exclusion Criteria:

* Known history of allergy or reaction to any component of the investigational product formulation
* Acute illness other than asthma at the start of the study
* Fever more than (\>) 38.6 degrees Celsius (C) (\>101.5 degrees Fahrenheit \[F\])
* Current acute asthma attack is due to aspirin-induced asthma
* Current asthma episode is an anaphylactoid/anaphylactic reaction presenting with acute bronchospasm
* Evidence of clinically significant non-respiratory active infection, including ongoing chronic infection
* History or current prolonged diarrhea, abdominal pain, and/or blood and mucus in stools or have minor symptoms and have exposure to stream or lake water, been exposed to someone who has a parasitic infection (like a family member), or study subject has traveled outside the United States of America (USA) and/or Canada within the last year
* Use of immunosuppressive medication (except oral prednisone and inhaled and topical corticosteroids) within 30 days before randomization into the study
* Have received Xolair within 6 months before randomization into the study
* Receipt of immunoglobulin or blood products within 30 days before randomization into the study
* Receipt of any investigational drug therapy within 6 months before the first dose of investigational product in this study through Day 168
* History of primary immunodeficiency
* Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study
* History of clinically significant abnormality on ECG in the opinion of the investigator
* Pregnancy (must have a negative serum pregnancy test prior to the first dose of investigational product)
* Breastfeeding or lactating woman
* History of treatment for alcohol or drug abuse within the past year
* Diagnosis of chronic obstructive pulmonary disease (COPD) by a healthcare professional
* Evidence of any clinically significant systemic disease on physical examination
* History of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy \>1 year prior to entry or other malignancies treated with apparent success with curative therapy \>5 years prior to entry
* Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma
* Any condition (that is, impending ventilatory failure or hemodynamic compromise) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results
* Any employee of the clinical study site who is involved with the conduct of the study
* History of cigarette smoking \>20 pack years
* Previously received benralizumab (MEDI-563)
* Asthma exacerbation due to acute inhalational exposure.

Answer: D