Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma

• Forced expiratory volume in the first second [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Number of asthma exacerbations [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Eosinophil levels [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

The purpose of this study is to determine the effectiveness and safety of reslizumab (the drug under study) 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 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.

• Biological: Reslizumab
  IV (in the vein) on Day 0 of each 28 day cycle (+/- 7 days) Number of Cycles=4
  Other Name: Cinquil™
• Other: Saline
  IV (in the vein) on Day 0 of each 28 day cycle (+/-7 days) Number of Cycles=4

• Experimental: 1
  Reslizumab 3 mg/kg
  Intervention: Biological: Reslizumab
• Placebo Comparator: 2
  Saline
  Intervention: Other: Saline

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, 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 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-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