A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
First received: January 25, 2011
Last updated: March 3, 2014
Last verified: March 2014
This study is being conducted to evaluate the efficacy, safety and immunogenicity of reslizumab treatment for adolescent and adult patients with eosinophilic asthma whose symptoms are inadequately controlled with inhaled corticosteroids. The primary objective of this study is to determine whether reslizumab, at a dose of 3 mg/kg administered intravenously (iv) every 4 weeks over 12 months, is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Frequency of clinical asthma exacerbations (CAEs) [ Time Frame: During the entire 52 week double-blind treatment period ] [ Designated as safety issue: No ]
A CAE is defined by 1 of the following: 1) a hospitalization because of asthma, 2) emergency treatment because of asthma, 3) a decrease in FEV1 by 20% or more from baseline, or 4) if the peak expiratory flow rate (PEFR) drops below 30% from baseline on 2 consecutive days.
Secondary Outcome Measures:
- Forced Expiratory Volume (FEV) [ Time Frame: At baseline and at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 or early withdrawal, or at time of first CAE ] [ Designated as safety issue: No ]
Lung function as measured by Forced Expiratory Volume (FEV) and percent predicted Forced Expiratory Volume in 1 second (%FEV1)
- Forced Vital Capacity (FVC) [ Time Frame: At baseline and at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 or early withdrawal, or at time of first CAE ] [ Designated as safety issue: No ]
- Forced Expiratory Flow at 25% to 75% of FVC (FEF25-75%) [ Time Frame: At baseline and at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 or early withdrawal, or at time of first CAE ] [ Designated as safety issue: No ]
- Time to first clinical asthma exacerbation (CAE) [ Time Frame: During the entire 52 week double-blind treatment period ] [ Designated as safety issue: No ]
- Number of courses of Oral Corticosteroids [ Time Frame: During the entire 52 week double-blind treatment period ] [ 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)
- Short-acting Beta-agonist usage [ Time Frame: during the entire 52 week treatment period ] [ Designated as safety issue: No ]
- Blood eosinophil count [ Time Frame: At baseline and at Weeks 4,8,12,16,20,24,28,32,36,40,44,48, and 52, or early withdrawal, or at time of first CAE ] [ Designated as safety issue: No ]
- Asthma Symptoms [ Time Frame: At baseline and at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 or early withdrawal, or at time of first CAE ] [ Designated as safety issue: No ]
Asthma symptoms will be measured by the Asthma Symptom Utility Index (ASUI)
- Asthma Control [ Time Frame: At baseline and at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 or early withdrawal, or at time of first CAE ] [ Designated as safety issue: No ]
Asthma control will be measured by the Asthma Control Questionnaire (ACQ).
- Quality of Life [ Time Frame: At baseline and at Weeks 16, 32, and 52 or early withdrawal, or at time of first CAE. ] [ Designated as safety issue: No ]
Quality of life will be measured by the Asthma Quality of Life Questionnaire (AQLQ).
- Occurrence of 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 ]
Safety will be assessed by evaluating the following: reported adverse events, clinical laboratory test results, vital signs measurements, ECG findings, physical examination findings (including body weight measurements), and concomitant medication usage.
- Immunogenicity [ Time Frame: At Baseline and at weeks 16, 32, 48, and 52 or early withdrawal ] [ Designated as safety issue: No ]
The immunogenicity of reslizumab will be evaluated by measurement of anti-reslizumab antibodies.
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2014 (Final data collection date for primary outcome measure)
3.0 mg/kg, administered intravenously (iv) once every 4 weeks over 52 weeks (a total of 13 doses administered).
Placebo Comparator: Placebo
Matching placebo (acetate sucrose buffer), administered intravenously (iv) once every 4 weeks over 52 weeks, for a total of 13 doses administered.
|Ages Eligible for Study:
||12 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 Germany, India, Argentina, and Korea; patients 66 through 75 years of age are excluded from participating in India and Korea.
- 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 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 dose of 10 mg prednisone daily or equivalent, leukotriene antagonists, 5-lipoxygenase inhibitors, or cromolyn) must be stable for 30 days prior to screening and baseline and must continue without dosage changes throughout the 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. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected). NOTE: Partner sterility alone is not acceptable for inclusion in the study.
- Written informed consent is obtained. Patients 12 through 17 years old, where participating, 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.
- The patient must be willing and able to understand and comply with study restrictions, requirements, and procedures, as specified by the study center, and to remain at the study center for the required duration during the study period, and willing to return to the study center for the follow-up evaluation as specified in this protocol.
- Patients who experience an asthma exacerbation during the screening period will be considered to have failed screening and cannot be randomly assigned to study drug. Patients may be rescreened 1 time only.
- 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, immunomodulating, or other biologic agents (including, but not limited to, anti-immunoglobulin E (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.
- Other exclusion criteria apply.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285323
Teva Pharmaceutical Industries
||Sponsor's Medical Expert, Senior Director - Worldwide Clinical Research
No publications provided
||Teva Pharmaceutical Industries
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 25, 2011
||March 3, 2014
||United States: Food and Drug Administration
Argentina: Ministry of Health
Brazil: Ministry of Health
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Greece: Ministry of Health and Welfare
Mexico: Ministry of Health
Peru: Ministry of Health
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Korea: Korea Food and Drug Administration (KFDA)
Ukraine: State Pharmacological Center - Ministry of Health
Taiwan : Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases