CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 233 enrolled
Drug / intervention
Benralizumab +1 moredrug
Likely dose
Not stated in 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/NCT02869438
NCT02869438Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation

AstraZeneca·interventional·Posted Aug 17, 2016·Updated Oct 29, 2019

In Brief

A Phase 3 clinical trial evaluating Benralizumab and Placebo for Asthma. Completed, enrolled 233 participants across 54 sites in 6 countries.

Detailed Summary

The purpose of this study is to investigate the onset and maintenance of effect of benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients will take part in body plethysmography substudy to further investigate the effect on lung function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesChile, Germany, Hungary, Philippines, South Korea, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 17, 2016
Enrollment StartNov 9, 2016
Primary CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.9 years ago

Interventions

Benralizumabdrug

Benralizumab administered subcutaneously at Visit 1 (Day 0), Visit 8 (Day28 +/- 3 days) and Visit 9 (Day 56 +/- 3 days)

Placeboother

Placebo administered subcutaneously at Visit 1 (Day 0), Visit 8 (Day28 +/- 3 days) and Visit 9 (Day 56 +/- 3 days)