Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma

An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation

The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.

Objectives:

Primary: To demonstrate the ability of reslizumab to improve asthma control in subjects with active asthma and eosinophilic airway inflammation.

Secondary:

• To study the ability of reslizumab to reduce induced sputum eosinophil (EOS) counts in subjects with asthma.
• To study the ability of reslizumab to reduce the number of eosinophilic clinical asthma exacerbations (CAE) in subjects with asthma. A CAE is defined as a ≥ 20% decrease in forced expiratory volume in 1 second (FEV1; absolute value) from the baseline value or a requirement for emergency treatment of asthma, hospital admission for asthma or treatment with three or more days of oral corticosteroids (OCS) for asthma worsening.
• To assess the safety and tolerability of reslizumab in subjects with asthma.

Inclusion Criteria:

• written informed consent
• male or female subjects aged ≥ 18 to 75 years at time of screening
• female if she is of non-childbearing potential, or of childbearing potential and willing to use specific barrier methods specified in protocol
• confirmation of asthma
• symptoms consistent with a diagnosis of asthma that is poorly controlled with an inhaled corticosteroid as determined by an Asthma Control Questionnaire (ACQ) score ≥ 1.5
• requirement for treatment with high dose daily fluticasone and at least one other agent for the treatment of asthma not specifically excluded in the protocol
• requirement for >/= 3% eosinophils in induced sputum at Screening

Exclusion Criteria:

• a clinically important event that would interfere with study schedule or procedure or compromise subject safety
• a diagnosis of hypereosinophilic syndrome
• an underlying lung disorder
• a current smoker
• use of systemic immunosuppressive agents within 6 months of study
• current use of systemic corticosteroids
• received attenuated live attenuated vaccines within three months prior to study entry
• expected to be poorly compliant with study drug, procedures, visits
• aggravating factors that are inadequately controlled
• participation in any investigational drug or device study within 30 days prior to study entry
• participation in biologics study within 3 months prior to study entry
• receipt of anti-human interleukin-5 (hIL-5) antibody within 6 months of study entry
• female subjects who are pregnant or nursing
• concurrent infection or disease that may preclude assessment of eosinophilic esophagitis
• concurrent immunodeficiency (human immunodeficiency [HIV], or acquired immunodeficiency syndrome [AIDS] or congenital immunodeficiency).
• current suspected drug and/or alcohol abuse