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 - Full Text View

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 (12 Through 75 Years of Age) With Eosinophilic Asthma Who Completed a Prior Cephalon-Sponsored Study in Eosinophilic Asthma

Resource links provided by NLM:

Genetics Home Reference related topics: PDGFRA-associated chronic eosinophilic leukemia PDGFRB-associated chronic eosinophilic leukemia

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Evaluate the Long-Term Safety of Reslizumab administration [ Time Frame: up to 104 weeks of treatment and a 90-day follow-up evaluation ] [ Designated as safety issue: Yes ]
- as assessed by adverse events, physical examination findings, vital sign measurements, concomitant medication usage, clinical laboratory test results, and measurement of antidrug antibodies

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 ]

Estimated Enrollment:	740
Study Start Date:	June 2011
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	November 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:

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 India and Argentina; patients 66 through 75 years of age are excluded from participating in India.
Written informed consent is obtained. Patients 12 through 17 years old, where participating, need to provide assent in accordance with local standards.
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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290887

Show 248 Study Locations

Sponsors and Collaborators

Cephalon

Investigators

Study Director:

Sponsor's Medical Expert, Senior Director - Worldwide Clinical Research

Cephalon

More Information

No publications provided

Responsible Party:	Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:	NCT01290887 History of Changes
Other Study ID Numbers:	C38072/3085
Study First Received:	February 4, 2011
Last Updated:	March 19, 2013
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 May 16, 2013