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

Completed · Phase 3 · Has a placebo group

Conditions studied: Eosinophilic Asthma

In brief

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).

Key facts

Study ID

NCT01270464

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

315

Starts

2011-02-01

Expected to finish

2013-09-01

Last updated by the study team

2016-06-06

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Teva Investigational Site 11 — Fountain Valley, California, United States
• Teva Investigational Site 43 — Los Angeles, California, United States
• Teva Investigational Site 4 — Orange, California, United States
• Teva Investigational Site 15 — Walnut Creek, California, United States
• Teva Investigational Site 2 — Colorado Springs, Colorado, United States
• Teva Investigational Site 24 — Largo, Florida, United States
• Teva Investigational Site 27 — Miami, Florida, United States
• Teva Investigational Site 5 — Miami, Florida, United States
• Teva Investigational Site 19 — Tallahassee, Florida, United States
• Teva Investigational Site 17 — Trinity, Florida, United States
• Teva Investigational Site 18 — Valrico, Florida, United States
• Teva Investigational Site 6 — Lilburn, Georgia, United States
• Teva Investigational Site 3 — Savannah, Georgia, United States
• Teva Investigational Site 7 — Iowa City, Iowa, United States
• Teva Investigational Site 8 — Omaha, Nebraska, United States
• Teva Investigational Site 26 — Summit, New Jersey, United States
• Teva Investigational Site 20 — Cincinnati, Ohio, United States
• Teva Investigational Site 1 — Medford, Oregon, United States
• Teva Investigational Site 73 — Lincoln, Rhode Island, United States
• Teva Investigational Site 9 — Providence, Rhode Island, United States
• Teva Investigational Site 21 — Charleston, South Carolina, United States
• Teva Investigational Site 16 — Fort Worth, Texas, United States
• Teva Investigational Site 10 — Houston, Texas, United States
• Teva Investigational Site 14 — San Antonio, Texas, United States
• Teva Investigational Site 12 — Anaheim, California, United States

Full record on ClinicalTrials.gov

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