Trial intelligence / Profile preview

MELTEMI: Benralizumab Safety Extension in Asthma

NCT02808819Phase 3

Key facts

Status: Completed
Start: Jun 2016
Primary completion: Jun 2020
Countries: 15
Sponsor: AstraZeneca
Modality: Monoclonal Antibodies

Drugs: benralizumab
Conditions: asthma

Overview

Phase 3, open-label trial of benralizumab in asthma (2 arms), sponsored by AstraZeneca. Primary endpoints: Change From Baseline in Basophils, Change From Baseline in Leukocytes and 10 more. Started Jun 2016; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Benralizumab Q4W
Benralizumab 30 mg SC every 4 weeks
Benralizumab Q8W
Benralizumab 30 mg SC every 8 weeks

Who it enrols

Adults with severe asthma who completed 16-40 weeks in the BORA study (NCT02258542).

Endpoints

Primary

Change From Baseline in BasophilsWeek 0 to End of Treatment
Change From Baseline in LeukocytesWeek 0 to End of Treatment
Change From Baseline in LymphocytesWeek 0 to End of Treatment
Change From Baseline in NeutrophilsWeek 0 to End of Treatment
Change From Baseline in MonocytesWeek 0 to End of Treatment

Secondary

Number of Participants With Asthma ExacerbationsWeek 0 to Week 184
Number of Participants Who Had Health Care EncounterWeek 0 to Week 184
Change of Blood Eosinophils CountWeek 0 to End of Treatment
Number of Participants With Anti-drug Antibodies ResponsesWeek 0 to Week 184
Duration of ExposureWeek 0 to Week 184

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