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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01270464
First received: December 29, 2010
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Eosinophilic Asthma
Drug: Reslizumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Overall change from baseline as assessed by Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    baseline to week 16 (or early withdrawal)


Secondary Outcome Measures:
  • Lung function as measured by percent predicted Forced Expiratory Volume in 1 second (% predicted FEV1) [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    from baseline to weeks 4, 8, 12, 16 or early withdrawal

  • Lung function as measured by Forced Vital Capacity (FVC) [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    from baseline to weeks 4, 8, 12, 16 or early withdrawal

  • Lung function as measured by Forced Expiratory Flow at 25% to 75% of FVC (FEF25-75%) [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    from baseline to weeks 4, 8, 12, 16 or early withdrawal

  • Short-acting beta-agonist use [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    from baseline to weeks 4, 8, 12, 16 or early withdrawal

  • Blood eosinophil count [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    from baseline to weeks 4, 8, 12, 16 and follow-up or early withdrawal

  • Asthma symptoms as measured by the Asthma Symptom Utility Index (ASUI) [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    from baseline to weeks 4, 8, 12, 16 or early withdrawal

  • Asthma control as measured by the Asthma Control Questionnaire (ACQ) [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    from baseline to weeks 4, 8, 12, 16 or early withdrawal

  • Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    from baseline to week 16 or early withdrawal

  • Evaluate the safety and tolerability of reslizumab treatment [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

    16 weeks + 90 day follow-up:

    • occurrence of adverse events
    • clinical laboratory test results
    • vital signs (blood pressures, pulse, body temperature, and respiratory rate) measurements at weeks 4, 8, 12, and 16 or early withdrawal and 90 (±7) days after the end-of treatment evaluation.
    • physical examination findings, including body weight measurements, at weeks 4, 8, 12, and 16 or early withdrawal
    • 12-lead electrocardiography (ECG) findings at week 16 or early withdrawal
    • concomitant medication usage throughout the study


Enrollment: 315
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reslizumab - 0.3 mg/kg
0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
Drug: Reslizumab
0.3 mg/kg, 3.0 mg/kg
Experimental: Reslizumab - 3.0 mg/kg
3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
Drug: Reslizumab
0.3 mg/kg, 3.0 mg/kg
Placebo Comparator: Placebo Drug: Placebo
Matching placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270464

  Show 89 Study Locations
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Sponsor's Medical Expert, Senior Director - Worldwide Clinical Research, MD Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01270464     History of Changes
Other Study ID Numbers: C38072/3081, 2010-023342-67
Study First Received: December 29, 2010
Last Updated: May 23, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Brazil: Ministry of Health
Canada: Health Canada
Colombia: National Institutes of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Mexico: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ministry of Health
Romania: National Medicines Agency
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Asthma
Pulmonary Eosinophilia
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014