CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 489 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/NCT01287039
NCT01287039Phase 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 Feb 1, 2011·Updated Nov 9, 2021

In Brief

A Phase 3 clinical trial evaluating Reslizumab and Placebo for Eosinophilic Asthma. Completed, enrolled 489 participants across 128 sites in 17 countries.

Detailed Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in patients with eosinophilic asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEosinophilic Asthma
CountriesAustralia, Belgium, Chile, Colombia, Czechia, Denmark, Hungary, Israel, Malaysia, New Zealand, Philippines, Poland, Russia, South Africa, Sweden, Thailand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2011
Enrollment StartApr 1, 2011
Primary CompletionDec 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 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 (20 mM sodium acetate, 7% sucrose), administered intravenously (iv) once every 4 weeks over 52 weeks, for a total of 13 doses administered. Each patient received a specific volume of placebo to match the volume of reslizumab on the basis of the patient's body weight.