Study of Reslizumab in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils

• Change in FEV1 [ Time Frame: Baseline, week 52 ]
• Change in Asthma Quality of Life Questionnaire [ Time Frame: 52 weeks ]
  Composite
• Change in Asthma Control Questionnaire [ Time Frame: Baseline, week 52 ]
  Composite
• Percentage of Participant with Adverse Events [ Time Frame: 52 weeks ]
• Change in total asthma symptom scores [ Time Frame: Baseline, Week 52 ]
• Asthma control days [ Time Frame: 52 weeks ]
• Change in St. George's Respiratory Questionnaire [ Time Frame: Baseline, week 32 ]
• Time to first clinical asthma exacerbation [ Time Frame: 52 weeks ]
• Frequency of exacerbations requiring hospitalization or emergency department visits [ Time Frame: 52 weeks ]
• Frequency of moderate exacerbations [ Time Frame: 52 weeks ]

• Drug: Reslizumab
  Reslizumab will be administered subcutaneously in a dose of 110 mg every 4 weeks.
• Drug: Placebo
  Matching Placebo

• Experimental: Reslizumab
  Reslizumab
  Intervention: Drug: Reslizumab
• Placebo Comparator: Placebo
  Matching Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• Written informed consent is obtained.
• The patient is male or female, 12 years of age and older, with a diagnosis of asthma.
• The patient has FEV1 reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol.
• The patient has required an inhaled corticosteroid.
• The patient has required an additional asthma controller medication besides inhaled corticosteroids.
• the patient has a history of asthma exacerbation.

• The patient must be willing and able to comply with study restrictions, perform requisite procedures and 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.

  • Additional criteria may apply, please contact the investigator for more information

Exclusion Criteria:

• The patient has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety.
• The patient has another confounding underlying lung disorder
• The patient has a known hypereosinophilic syndrome.
• The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
• The patient is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study.
• The patient is a current smoker or has a smoking history.
• The patient participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
• The patient was previously exposed to reslizumab.
• The patient has a history of an immunodeficiency disorder including HIV.
• The patient has current or suspected drug and alcohol abuse.
• The patient has an active helminthic parasitic infection or was treated for one within 6 months of screening.

• The patient has a history of allergic reaction or hypersensitivity to any component of the study drug.

  • Additional criteria may apply, please contact the investigator for more information