Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01290887
First received: February 4, 2011
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.


Condition Intervention Phase
Eosinophilic Asthma
Drug: Reslizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Teva-Sponsored Study in Eosinophilic Asthma

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Summary of participants with adverse events [ Time Frame: up to 104 weeks of treatment and a 90-day follow-up evaluation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lung function as measured by Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Lung function as measured by percent predicted Forced Expiratory Volume in 1 second (%FEV1) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Lung function as measured by Forced Vital Capacity (FVC) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Lung function as measured by Forced Expiratory Flow at 25% to 75% FVC (FEF25-75%) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Short-acting Beta-agonist usage [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Asthma symptoms as measured by the Asthma Symptom Utility Index (ASUI) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Asthma control as measured by the Asthma Control Questionnaire (ACQ) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: 116 weeks ] [ Designated as safety issue: No ]

Enrollment: 1052
Study Start Date: June 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reslizumab Drug: Reslizumab
Reslizumab (3.0 mg/kg) will be administered intravenously by infusion every 28 days (±7 days), for approximately 24 months

  Eligibility

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

Inclusion Criteria:

  • Written informed consent is obtained.
  • Patient must have completed treatment in a previous Cephalon-sponsored double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
  • 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 willing to return to the clinic for the follow-up evaluation as specified in this protocol.
  • other criteria may apply; please contact the investigator for more information.

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 another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
  • The patient is a current smoker.
  • 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 (e.g., gastroesophageal reflux disease [GERD]).
  • Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (eg, spermicide, abstinence, intrauterine device [IUD], or steroidal contraceptive [oral, transdermal, implanted, and injected] in conjunction with a barrier method) are excluded from this study.
  • The patient has a current infection or disease that may preclude assessment of asthma.
  • other criteria may apply; please contact the investigator for more information.
  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: NCT01290887

  Show 258 Study Locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Sponsor's Medical Expert, Senior Director - Worldwide Clinical Research Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01290887     History of Changes
Other Study ID Numbers: C38072/3085, 2010-024540-15
Study First Received: February 4, 2011
Last Updated: August 27, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belarus: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Canada: Health Canada
Chile: Ministry of Health
Colombia: National Institutes of Health
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Greece: Ministry of Health and Welfare
Hungary: National Institute of Pharmacy
India: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Malaysia: Ministry of Health
Mexico: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
New Zealand: Ministry of Health
Norway: Norwegian Medicines Agency
Peru: Ministry of Health
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Sweden: Medical Products Agency
Thailand: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health

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