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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

NCT06750289 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-13

No results posted yet for this 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

Interventions

COMBINATION_PRODUCT

ICS-LABA

ICS-LABA inhalation

COMBINATION_PRODUCT

benralizumab

Benralizumab. SC injection.

COMBINATION_PRODUCT

Placebo for Benralizumab

Placebo for Benralizumab (aka, "placebo"). SC injection.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-28
Primary Completion
2028-11-03
Completion
2028-11-03
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • Ireland
  • Italy
  • Norway
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06750289 on ClinicalTrials.gov