A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma
Condition: Eosinophilic Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Intervention: Reslizumab; Placebo
Intervention description: Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses.; Matching placebo (20 mM sodium acetate, 7% sucrose), administered intravenously (iv) once every 4 weeks over 52 weeks, for a total of 13 doses administered. Each patient received a specific volume of placebo to match the volume of reslizumab on the basis of the patient's body weight.
Intervention MeSH terms: Reslizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 489.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group
      study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in
      patients with eosinophilic asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is male or female, 12 through 75 years of age, with a previous diagnosis
             of asthma.

          -  The patient has had at least 1 asthma exacerbation requiring oral, intramuscular (im),
             or intravenous (iv) corticosteroid use for at least 3 days over the past 12 months
             before screening.

          -  The patient has a current blood eosinophil level of at least 400/μl.

          -  The patient has airway reversibility of at least 12% to beta-agonist administration.

          -  The patient has an ACQ score of at least 1.5 at the screening and baseline (before the
             1st dose of study drug) visits.

          -  The patient is taking inhaled fluticasone at a dosage of at least 440 μg, or
             equivalent, daily. Chronic oral corticosteroid use (no more than 10 mg/day prednisone
             or equivalent) is allowed. If a patient is on a stable dose, eg, 2 weeks or more of
             oral corticosteroid treatment at the time of study enrollment, the patient must remain
             on this dose throughout the study. The patient's baseline asthma therapy regimen
             (including but not limited to inhaled corticosteroids, oral corticosteroids up to a
             maximum of 10 mg of prednisone daily or equivalent, leukotriene antagonists,
             5-lipooxygenase inhibitors, or cromolyn) must be stable for 30 days prior to screening
             and baseline, and must continue without dosage changes throughout study.

          -  All female patients must be surgically sterile, 2 years postmenopausal, or must have a
             negative pregnancy test ß-human chorionic gonadotropin [ß-HCG]) 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
             participation in the study.

          -  Written informed consent is obtained. Patients 12 through 17 years old must provide
             assent.

          -  The patient is in reasonable health (except for diagnosis of asthma) as judged by the
             investigator, and as determined by a medical history, medical examination, ECG
             evaluation (at screening), serum chemistry, hematology, and urinalysis.

               -  Other criteria apply; please contact the investigator for more information.

        Exclusion Criteria:

          -  The patient has a clinically meaningful co-morbidity that would interfere with the
             study schedule or procedures, or compromise the patient's safety.

          -  The patient has known hypereosinophilic syndrome.

          -  The patient has another confounding underlying lung disorder (eg, chronic obstructive
             pulmonary disease, pulmonary fibrosis, or lung cancer). Patients with pulmonary
             conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome,
             allergic bronchopulmonary aspergillosis) will also be excluded.

          -  The patient is a current smoker (ie, has smoked within the last 6 months prior to
             screening).

          -  The patient is using systemic immunosuppressive or immunomodulating or other biologic
             agents (including, but not limited to, anti-IgE mAb, methotrexate, cyclosporin,
             interferon-α, or anti-tumor necrosis factor [anti TNF] mAb) within 6 months prior to
             screening.

          -  The patient has previously received an anti-hIL-5 monoclonal antibody (eg, reslizumab,
             mepolizumab, or benralizumab).

          -  The patient has any aggravating medical factors that are inadequately controlled (eg,
             rhinitis, gastroesophageal reflux disease, and uncontrolled diabetes).

          -  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 6 months
             prior to screening.

          -  Female patients who are pregnant, nursing, or, if of childbearing potential, and not
             using a medically accepted, effective method of birth control (eg, barrier method with
             spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted,
             and injected]) are excluded from this study. NOTE: Partner sterility alone is not
             considered an acceptable form of birth control.

               -  Other criteria apply; please contact the investigator for more information.