drugset / Trial / NCT01290887

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

NCT01290887

Phase 3 Terminated 1052 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2011-06
Primary completion
2015-01
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Reslizumab Monoclonal antibody 3 mg/kg Intravenous

Indications