Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma

Inclusion criteria:

Patients are included in the study if all of the following criteria are met:

- The patient is a man or woman, 18 through 65 years of age, with a diagnosis of
asthma.

- The patient has an ACQ score of at least 1.5.

- At screening, the patient has airway reversibility of at least 12% to beta-agonist
administration.

- The patient is currently taking fluticasone at a dosage of at least 440 µg daily (or
equivalent). Patients' baseline asthma therapy regimens (including but not limited
to inhaled corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors,
cromolyn) must be stable for 30 days before screening and continue without dosage
changes throughout study.

- Female patients must be surgically sterile, 2 years postmenopausal, or must have a
negative beta-human chorionic gonadotropin (ßHCG) result for a pregnancy test 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. Acceptable methods of contraception include barrier
method with spermicide, abstinence, intrauterine device (IUD), or steroidal
contraceptive (oral, transdermal, implanted, and injected).

- Written informed consent is obtained.

- 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,
electrocardiogram (ECG) evaluation, serum chemistry, hematology, urinalysis, and
serology.

- The patient must be willing and able to comply with study restrictions and to remain
at the clinic for the required duration during the study period, and be willing to
return to the clinic for the follow-up evaluation as specified in this protocol.

Exclusion Criteria:

Patients are excluded from participating in this study if 1 or more of the following
criteria are met:

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

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

- The patient has known hypereosinophilic syndrome (HES).

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

- The patient has a history of use of systemic immunosuppressive or immunomodulating
agents (anti-immunoglobulin E [anti-IgE] mAb, methotrexate, cyclosporin,
interferon-α, anti-tumor necrosis factor mAb, or omalizumab) within 6 months prior to
study entry (randomization).

- The patient is currently using or has used systemic corticosteroids (includes use of
oral corticosteroids) within 30 days prior to the screening visit.

- The patient is expected to be poorly compliant with study drug administration, study
procedures, or visits.

- The patient has any aggravating factors that are inadequately controlled, and thus
would aggravate asthma symptoms (eg, gastroesophageal reflux disease).

- 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 90 days
prior to screening.

- The patient has previously received reslizumab or other anti-hIL-5 mAbs (eg,
mepolizumab).

- The patient is a pregnant or lactating woman. (Any women becoming pregnant during
the study will be withdrawn from the study.)

- The patient has a current infection or disease that may preclude assessment of
asthma.

- The patient has a history of concurrent immunodeficiency (human immunodeficiency,
acquired immunodeficiency syndrome, or congenital immunodeficiency).

- The patient is suspected of current drug or alcohol abuse as specified in the
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision
(DSM-IV-TR) criteria.

- The patient has presence of or suspected parasitic infestation/infection.

- Patients may not have received any live attenuated vaccine within the 12-week period
before study entry.