A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma
Condition: Eosinophilic Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Intervention: Reslizumab; Placebo
Intervention description: 3.0 mg/kg or 0.3 mg/kg doses administered intravenously (iv) by qualified site personnel once every 4 weeks, for a total of 4 doses.; Placebo administered by iv infusion by qualified study personnel every 4 weeks for a total of 4 doses.
Intervention MeSH terms: Reslizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 315.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or
      3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than
      placebo in improving lung function in patients with eosinophilic asthma as assessed by the
      overall change from baseline in forced expiratory volume in 1 second (FEV1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is male or female, 12 through 75 years of age, with a previous diagnosis
             of asthma. Patients 12 through 17 years of age are excluded from participating in
             Argentina.

          -  The patient has an ACQ score of at least 1.5.

          -  The patient has airway reversibility of at least 12% to beta-agonist administration at
             screening.

          -  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.

          -  The patient has a blood eosinophil count of at least 400/μL.

          -  Female patients must be surgically sterile, 2 years postmenopausal, or must have a
             negative pregnancy test ßHCG 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 the
             end-of-treatment visit. 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. Patients 12 through 17 years old, where
             participating, need to provide assent in accordance with local standards.

          -  Other inclusion criteria apply.

        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 known hypereosinophilic syndrome (HES).

          -  The patient has another confounding underlying lung disorder (eg, chronic obstructive
             pulmonary disease, pulmonary fibrosis, or lung cancer). The patient has other
             pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss
             syndrome, allergic bronchopulmonary aspergillosis).

          -  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-IgE mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis
             factor mAb) within 6 months prior to study entry (screening).

          -  The patient is currently using systemic corticosteroids (includes use of oral
             corticosteroids).

          -  The patient has a current infection or disease that may preclude assessment of asthma.

          -  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 (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 anti-hIL-5 monoclonal antibody (eg, mepolizumab).

          -  Female patients who are pregnant, or nursing, or, if of childbearing potential and not
             using a medically accepted, effective method of birth control (e.g. spermicide,
             abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and
             injected]) are excluded from this 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). Patients in
             Argentina must have documented serology testing for HIV performed during screening.

          -  Other exclusion criteria apply.