Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Eosinophilic Asthma

In brief

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).

Key facts

Study ID

NCT01508936

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

511

Starts

2012-02-01

Expected to finish

2013-08-01

Last updated by the study team

2016-06-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site 842 — Homewood, Alabama, United States
• Investigational Site 887 — Jasper, Alabama, United States
• Investigational Site 809 — Tucson, Arizona, United States
• Investigational Site 892 — Tucson, Arizona, United States
• Investigational Site 846 — Little Rock, Arkansas, United States
• Investigational Site 828 — Anaheim, California, United States
• Investigational Site 900 — Fresno, California, United States
• Investigational Site 862 — Huntington Beach, California, United States
• Investigational Site 852 — Los Angeles, California, United States
• Investigational Site 909 — Los Angeles, California, United States
• Investigational Site 864 — Newport Beach, California, United States
• Investigational Site 812 — Rancho Mirage, California, United States
• Investigational Site 808 — Riverside, California, United States
• Investigational Site 804 — Sacramento, California, United States
• Investigational Site 837 — Centennial, Colorado, United States
• Investigational Site 851 — Denver, Colorado, United States
• Investigational Site 832 — Wheat Ridge, Colorado, United States
• Investigational Site 855 — Jacksonville, Florida, United States
• Investigational Site 865 — Miami, Florida, United States
• Investigational Site 881 — Miami, Florida, United States
• Investigational Site 805 — Albany, Georgia, United States
• Investigational Site 870 — Stockbridge, Georgia, United States
• Investigational Site 816 — Chicago, Illinois, United States
• Investigational Site 824 — Shiloh, Illinois, United States
• Investigational Site 861 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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