NCT01270464

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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 as assessed by the overall change from baseline in forced expiratory volume in 1 second (FEV1).

Conditions

• Eosinophilic Asthma

Interventions

Type	Name	Description
DRUG	Reslizumab	3.0 mg/kg or 0.3 mg/kg doses administered intravenously (iv) by qualified site personnel once every 4 weeks, for a total of 4 doses.
DRUG	Placebo	Placebo administered by iv infusion by qualified study personnel every 4 weeks for a total of 4 doses.

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-01-05
• Last updated: 2016-06-06
• Results posted: 2016-06-06

Locations

89 sites across 13 countries: United States, Argentina, Belgium, Brazil, Canada, Colombia, France, Hungary, Israel, Mexico, Netherlands, Poland, Sweden