A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

Demonstrate the efficacy of reslizumab, at a dose of 3 mg/kg administered iv every 4 weeks
over 12 months, as assessed by the reduction in frequency of clinical asthma exacerbations
(CAEs) during 12 months.

An exacerbation event will be considered a CAE if the patient meets either or both of the
criteria listed below and this is corroborated with at least 1 other measurement to indicate
the worsening of clinical signs and symptoms of asthma:

- use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3
or more days

- asthma-related emergency treatment The above criteria must be corroborated with at
least 1 other measurement to indicate worsening in the clinical signs and symptoms of
asthma.

Inclusion Criteria:

- The patient is male or female, 12 through 75 years of age, with a previous diagnosis
of asthma.

- The patient has had at least 1 asthma exacerbation requiring oral, intramuscular
(im), or intravenous (iv) corticosteroid use for at least 3 days over the past 12
months before screening.

- The patient has a current blood eosinophil level of at least 400/μl.

- The patient has airway reversibility of at least 12% to beta-agonist administration.

- The patient has an ACQ score of at least 1.5 at the screening and baseline (before
the 1st dose of study drug) visits.

- The patient is taking inhaled fluticasone at a dosage of at least 440 μg, or
equivalent, daily. Chronic oral corticosteroid use (no more than 10 mg/day prednisone
or equivalent) is allowed. If a patient is on a stable dose, eg, 2 weeks or more of
oral corticosteroid treatment at the time of study enrollment, the patient must
remain on this dose throughout the study. The patient's baseline asthma therapy
regimen (including but not limited to inhaled corticosteroids, oral corticosteroids
up to a maximum of 10 mg of prednisone daily or equivalent, leukotriene antagonists,
5-lipooxygenase inhibitors, or cromolyn) must be stable for 30 days prior to
screening and baseline, and must continue without dosage changes throughout study.

- All female patients must be surgically sterile, 2 years postmenopausal, or must have
a negative pregnancy test ß-human chorionic gonadotropin [ß-HCG]) at screening
(serum) and baseline (urine).

- Female patients of childbearing potential (not surgically sterile or 2 years
postmenopausal), must use a medically accepted method of contraception and must agree
to continue use of this method for the duration of the study and for 30 days after
participation in the study.

- Written informed consent is obtained. Patients 12 through 17 years old must provide
assent.

- The patient is in reasonable health (except for diagnosis of asthma) as judged by the
investigator, and as determined by a medical history, medical examination, ECG
evaluation (at screening), serum chemistry, hematology, and urinalysis.

- Other criteria apply; please contact the investigator for more information.

Exclusion Criteria:

- The patient has a clinically meaningful co-morbidity that would interfere with the
study schedule or procedures, or compromise the patient's safety.

- The patient has known hypereosinophilic syndrome.

- The patient has another confounding underlying lung disorder (eg, chronic obstructive
pulmonary disease, pulmonary fibrosis, or lung cancer). Patients with pulmonary
conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss
syndrome, allergic bronchopulmonary aspergillosis) will also be excluded.

- The patient is a current smoker (ie, has smoked within the last 6 months prior to
screening).

- The patient is using systemic immunosuppressive or immunomodulating or other biologic
agents (including, but not limited to, anti-IgE mAb, methotrexate, cyclosporin,
interferon-α, or anti-tumor necrosis factor [anti TNF] mAb) within 6 months prior to
screening.

- The patient has previously received an anti-hIL-5 monoclonal antibody (eg,
reslizumab, mepolizumab, or benralizumab).

- The patient has any aggravating medical factors that are inadequately controlled (eg,
rhinitis, gastroesophageal reflux disease, and uncontrolled diabetes).

- The patient has participated in any investigative drug or device study within 30 days
prior to screening.

- The patient has participated in any investigative biologics study within 6 months
prior to screening.

- Female patients who are pregnant, nursing, or, if of childbearing potential, and not
using a medically accepted, effective method of birth control (eg, barrier method
with spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal,
implanted, and injected]) are excluded from this study. NOTE: Partner sterility alone
is not considered an acceptable form of birth control.

- Other criteria apply; please contact the investigator for more information.