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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Eosinophilic Asthma

Treatments: Drug: Reslizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01270464

2010-023342-67 (EudraCT Number)

C38072/3081

Details and patient eligibility

About

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).

Enrollment: 315 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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315 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.

Treatment:

Drug: Placebo

Reslizumab - 0.3 mg/kg

Experimental group

Description:

0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses

Treatment:

Drug: Reslizumab

Reslizumab - 3.0 mg/kg

Experimental group

Description:

3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.

Treatment:

Drug: Reslizumab