CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 464 enrolled
Drug / intervention
Reslizumab +1 moredrug
Likely dose
Reslizumab 3.0 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01285323
NCT01285323Phase 3Completed
CompareCT.gov

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

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Jan 28, 2011·Updated Nov 9, 2021

In Brief

A Phase 3 clinical trial evaluating Reslizumab and Placebo for Eosinophilic Asthma. Completed, enrolled 464 participants across 104 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEosinophilic Asthma
CountriesArgentina, Brazil, Canada, France, Germany, Greece, Mexico, Peru, Romania, Russia, Slovakia, South Korea, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 28, 2011
Enrollment StartMar 1, 2011
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.4 years ago

Interventions

Reslizumabdrug

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.

Placebodrug

Matching placebo (acetate sucrose buffer), administered intravenously (iv) once every 4 weeks for a total of 13 doses.