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NCT06750289Phase 3RECRUITING

Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment

Study Summary

This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.

Conditions
Eosinophilic Asthma
Interventions / Drugs
ICS-LABAbenralizumabPlacebo for Benralizumab
View on ClinicalTrials.gov ↗
Sponsor
AZN
AstraZeneca
Oncology/Respiratory
F16/100
Study Details
Enrollment400 participants
Primary Completion—
Lead SponsorAstraZeneca
Data Retrieved2026-04-11 02:55:19.909325+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 400 participants
Sponsor Catalyst Profile

AstraZeneca (AZN) is the sponsoring company for this trial. BiotechSign currently grades this company F (16/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

AZN Full Pipeline →All Companies →
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