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

Completed · Phase 3 · Has a placebo group

Conditions studied: Eosinophilic Asthma

In brief

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.

Key facts

Study ID

NCT01287039

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

489

Starts

2011-04-01

Expected to finish

2014-03-01

Last updated by the study team

2021-11-09

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.
• 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.

You may not qualify if…

• 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.

Where it is running

• Teva Investigational Site 61 — Los Angeles, California, United States
• Teva Investigational Site 37 — Orange, California, United States
• Teva Investigational Site 56 — San Diego, California, United States
• Teva Investigational Site 34 — Colorado Springs, Colorado, United States
• Teva Investigational Site 52 — DeBary, Florida, United States
• Teva Investigational Site 55 — Miami, Florida, United States
• Teva Investigational Site 18 — Valrico, Florida, United States
• Teva Investigational Site 49 — Lexington, Kentucky, United States
• Teva Investigational Site 65 — Louisville, Kentucky, United States
• Teva Investigational Site 51 — Boston, Massachusetts, United States
• Teva Investigational Site 74 — St Louis, Missouri, United States
• Teva Investigational Site 35 — Missoula, Montana, United States
• Teva Investigational Site 64 — Boys Town, Nebraska, United States
• Teva Investigational Site 68 — Rochester, New York, United States
• Teva Investigational Site 60 — The Bronx, New York, United States
• Teva Investigational Site 30 — Winston-Salem, North Carolina, United States
• Teva Investigational Site 31 — Cincinnati, Ohio, United States
• Teva Investigational Site 62 — Columbus, Ohio, United States
• Teva Investigational Site 50 — Oklahoma City, Oklahoma, United States
• Teva Investigational Site 66 — Altoona, Pennsylvania, United States
• Teva Investigational Site 32 — Nashville, Tennessee, United States
• Teva Investigational Site 63 — Boerne, Texas, United States
• Teva Investigational Site 72 — Houston, Texas, United States
• Teva Investigational Site 38 — Richmond, Virginia, United States
• Teva Investigational Site 58 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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