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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01287039
First received: January 28, 2011
Last updated: August 20, 2014
Last verified: August 2014

January 28, 2011
August 20, 2014
March 2011
December 2013   (final data collection date for primary outcome measure)
Frequency of clinical asthma exacerbations (CAE) [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Overall change in forced expiratory volume in 1 second (FEV1) [ Time Frame: From baseline to Week 16, or the onset of first CAE, whichever occurs first ] [ Designated as safety issue: No ]
  • A reduction in the frequency (i.e., number) of clinical asthma exacerbations (CAEs) [ Time Frame: during the full treatment period of 52 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01287039 on ClinicalTrials.gov Archive Site
  • Lung function as measured by Forced Expiratory Volume (FEV1) [ Time Frame: Baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52, or early withdrawal ] [ Designated as safety issue: No ]
  • Time to first clinical asthma exacerbation (CAE) [ Time Frame: Baseline through week 52 or early withdrawal ] [ Designated as safety issue: No ]
  • Short-acting Beta-agonist usage [ Time Frame: Baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32,36, 40,44,48, and 52, or early withdrawal ] [ Designated as safety issue: No ]
  • Blood eosinophil count [ Time Frame: Baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52, or early withdrawal ] [ Designated as safety issue: No ]
  • Asthma Symptom Utility Index (ASUI) [ Time Frame: Baseline to weeks 4, 8, 12, 16, 20, 24, 28 , 32, 36, 40, 44, 48, and 52 or early withdrawal ] [ Designated as safety issue: No ]
  • Asthma Control Questionnaire (ACQ) [ Time Frame: Baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 or early withdrawal ] [ Designated as safety issue: No ]
  • Asthma Quality of Life Questionnaire [ Time Frame: Baseline to weeks 16, 32, and 52, or early withdrawal ] [ Designated as safety issue: No ]
    Quality of life will be measured by the Asthma Quality of Life Questionnaire (AQLQ).
  • Summary of Participants with Adverse Events [ Time Frame: From signing of the informed consent form (ICF) through the end of the follow-up period. (approximately 64 weeks) ] [ Designated as safety issue: Yes ]
  • Lung function as measured by Forced Expiratory Volume (FEV1) [ Designated as safety issue: No ]
  • Lung function as measured by percent predicted Forced Expiratory Volume in 1 second (%FEV1) [ Designated as safety issue: No ]
  • Lung function as measured by Forced Vital Capacity (FVC) [ Designated as safety issue: No ]
  • Lung function as measured by Forced Expiratory Flow at 25% to 75% of FVC (FEF25-75%) [ Designated as safety issue: No ]
  • Measurement of time to first clinical asthma exacerbation (CAE) [ Designated as safety issue: No ]
  • Document the courses of oral corticosteroids prescribed for asthma worsening (3 or more days of administration or doubling of current dose) [ Designated as safety issue: No ]
  • Short-acting Beta-agonist usage [ Time Frame: during the entire 52 week treatment period ] [ Designated as safety issue: No ]
  • Blood eosinophil count [ Designated as safety issue: No ]
  • Asthma symptoms as measured by the Asthma Symptom Utility Index (ASUI) [ Designated as safety issue: No ]
  • Asthma control as measured by the Asthma Control Questionnaire (ACQ) [ Designated as safety issue: No ]
  • Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) [ Designated as safety issue: No ]
  • Safety and tolerability of reslizumab treatment in patients with eosinophilic asthma [ Time Frame: during the entire 52 week treatment period ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group 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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Eosinophilic Asthma
  • Drug: Reslizumab
    3.0 mg/kg, administered intravenously (iv) once every 4 weeks over 52 weeks (a total of 13 doses administered)
  • Drug: Placebo
    Matching placebo (20 mM sodium acetate, 7% sucrose), administered intravenously (iv) once every 4 weeks over 52 weeks, for a total of 13 doses administered
  • Experimental: Reslizumab
    Intervention: Drug: Reslizumab
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
489
April 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
12 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Chile,   United States,   Colombia,   Belgium,   Czech Republic,   Denmark,   Hungary,   Israel,   Poland,   Russian Federation,   South Africa,   Sweden,   Australia,   Malaysia,   New Zealand,   Philippines,   Thailand
 
NCT01287039
C38072/3082
Not Provided
Teva Pharmaceutical Industries ( Cephalon )
Cephalon
Not Provided
Study Director: Medical Expert, MD TEVA
Teva Pharmaceutical Industries
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP