NCT01285323

A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma

A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 464 (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 is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.

Conditions

• Eosinophilic Asthma

Interventions

Type	Name	Description
DRUG	Reslizumab	Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses.
DRUG	Placebo	Matching placebo (acetate sucrose buffer), administered intravenously (iv) once every 4 weeks for a total of 13 doses.

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2011-01-28
• Last updated: 2021-11-09
• Results posted: 2016-06-27

Locations

104 sites across 15 countries: United States, Argentina, Brazil, Canada, France, Germany, Greece, Mexico, Peru, Romania, Russia, Slovakia, South Korea, Taiwan, Ukraine