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

Stopped early · Phase 3

Conditions studied: Eosinophilic Asthma

In brief

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.

Key facts

Study ID

NCT01290887

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

1052

Starts

2011-06-01

Expected to finish

2015-01-01

Last updated by the study team

2016-06-06

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Teva Investigational Site 12 — Anaheim, California, United States
• Teva Investigational Site 11 — Fountain Valley, California, United States
• Teva Investigational Site 41 — Fresno, California, United States
• Teva Investigational Site 59 — Long Beach, California, United States
• Teva Investigational Site 43 — Los Angeles, California, United States
• Teva Investigational Site 4 — Orange, California, United States
• Teva Investigational Site 15 — Walnut Creek, California, United States
• Teva Investigational Site 2 — Colorado Springs, Colorado, United States
• Teva Investigational Site 34 — Colorado Springs, Colorado, United States
• Teva Investigational Site 47 — Denver, Colorado, United States
• Teva Investigational Site 28 — Waterbury, Connecticut, United States
• Teva Investigational Site 53 — Clearwater, Florida, United States
• Teva Investigational Site 24 — Largo, Florida, United States
• Teva Investigational Site 27 — Miami, Florida, United States
• Teva Investigational Site 55 — Miami, Florida, United States
• Teva Investigational Site 5 — Miami, Florida, United States
• Teva Investigational Site 52 — Orlando, Florida, United States
• Teva Investigational Site 19 — Tallahassee, Florida, United States
• Teva Investigational Site 17 — Trinity, Florida, United States
• Teva Investigational Site 18 — Valrico, Florida, United States
• Teva Investigational Site 25 — Lawrenceville, Georgia, United States
• Teva Investigational Site 6 — Lilburn, Georgia, United States
• Teva Investigational Site 3 — Savannah, Georgia, United States
• Teva Investigational Site 49 — Lexington, Kentucky, United States
• Teva Investigational Site 58 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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