Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma
Condition: Eosinophilic Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Intervention: Reslizumab
Intervention description: Reslizumab (3.0 mg/kg) administered intravenously by infusion every 28 days (±7 days), for approximately 24 months
Intervention MeSH terms: Reslizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1052.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to evaluate the long-term safety of reslizumab at a
      dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients
      with eosinophilic asthma as assessed by adverse events, physical examination findings, vital
      sign measurements, and concomitant medication usage throughout the study (every 4 weeks),
      clinical laboratory test results, and measurement of antidrug antibodies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent is obtained.

          -  Patient must have completed treatment in a previous Cephalon-sponsored double-blind
             asthma exacerbation study or received at least 2 doses of study drug treatment in a
             pulmonary function study.

          -  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 willing to return
             to the clinic for the follow-up evaluation as specified in this protocol.

          -  other criteria may apply; please contact the investigator for more information.

        Exclusion Criteria:

          -  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 another confounding underlying lung disorder (eg, chronic obstructive
             pulmonary disease, pulmonary fibrosis, or lung cancer).

          -  The patient is a current smoker.

          -  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 (e.g.,
             gastroesophageal reflux disease [GERD]).

          -  Female patients who are pregnant, or nursing, or, if of childbearing potential and not
             using a medically accepted, effective method of birth control (eg, spermicide,
             abstinence, intrauterine device [IUD], or steroidal contraceptive [oral, transdermal,
             implanted, and injected] in conjunction with a barrier method) are excluded from this
             study.

          -  The patient has a current infection or disease that may preclude assessment of asthma.

          -  other criteria may apply; please contact the investigator for more information.