Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma
Condition: Eosinophilic Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Intervention: Reslizumab; Placebo
Intervention description: Reslizumab administered at a dosage of 3.0 mg/kg by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).; Matching placebo administered by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 511.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to characterize the efficacy of reslizumab treatment,
      at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in
      improving pulmonary function in relation to baseline blood eosinophil levels in patients with
      moderate to severe asthma, as assessed by the change from baseline to week 16 in forced
      expiratory volume in 1 second (FEV1).
    

Eligibility criteria:

        Inclusion criteria:

        Patients are included in the study if all of the following criteria are met:

          -  The patient is a man or woman, 18 through 65 years of age, with a diagnosis of asthma.

          -  The patient has an ACQ score of at least 1.5.

          -  At screening, the patient has airway reversibility of at least 12% to beta-agonist
             administration.

          -  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.

          -  Female patients must be surgically sterile, 2 years postmenopausal, or must have a
             negative beta-human chorionic gonadotropin (ßHCG) result for a pregnancy test 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. 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.

          -  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,
             electrocardiogram (ECG) evaluation, serum chemistry, hematology, urinalysis, and
             serology.

          -  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 be willing to
             return to the clinic for the follow-up evaluation as specified in this protocol.

        Exclusion Criteria:

        Patients are excluded from participating in this study if 1 or more of the following
        criteria are met:

          -  The patient has another confounding underlying lung disorder (eg, chronic obstructive
             pulmonary disease, pulmonary fibrosis, lung cancer). The patient has other pulmonary
             conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome,
             allergic bronchopulmonary aspergillosis).

          -  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 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-immunoglobulin E [anti-IgE] mAb, methotrexate, cyclosporin, interferon-α,
             anti-tumor necrosis factor mAb, or omalizumab) within 6 months prior to study entry
             (randomization).

          -  The patient is currently using or has used systemic corticosteroids (includes use of
             oral corticosteroids) within 30 days prior to the screening visit.

          -  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, and thus
             would aggravate asthma symptoms (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 reslizumab or other anti-hIL-5 mAbs (eg,
             mepolizumab).

          -  The patient is a pregnant or lactating woman. (Any women becoming pregnant during the
             study will be withdrawn from the 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).

          -  The patient is suspected of current drug or alcohol abuse as specified in the
             Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision
             (DSM-IV-TR) criteria.

          -  The patient has presence of or suspected parasitic infestation/infection.

          -  Patients may not have received any live attenuated vaccine within the 12-week period
             before study entry.