CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 964 enrolled
Drug / intervention
Benralizumab 2 mg +3 morebiological
Likely dose
Benralizumab 2 mgfrom 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/NCT01238861
NCT01238861Phase 2Completed
CompareCT.gov

A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

MedImmune LLC·interventional·Posted Nov 11, 2010·Updated Nov 17, 2016

In Brief

A Phase 2 clinical trial evaluating Benralizumab 2 mg, Benralizumab 20 mg, and 2 other interventions for Asthma. Completed, enrolled 964 participants across 74 sites in 10 countries.

Detailed Summary

The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Brazil, Bulgaria, Canada, Colombia, Mexico, Peru, Poland, Russia, United States
CollaboratorsMedImmune Ltd

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2010
Enrollment StartDec 1, 2010
Primary CompletionMar 1, 2013
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.6 years ago

Interventions

Benralizumab 2 mgbiological

EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.

Benralizumab 20 mgbiological

EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.

Benralizumab 100 mgbiological

EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.

Placeboother

EOS+ and EOS- participants received two placebo injections subcutaneously.