STEP: Phase IIIb study of benralizumab to step-down maintenance therapy in patients with severe eosinophilic asthma - STEP

Study identifier:D3250L00046

ClinicalTrials.gov identifier:NCT06465485

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

STEP: A Prospective, Interventional, Multicenter, Single-Arm Phase 3b Study to Evaluate the Step-Down of Maintenance Therapy in Patients with Severe Eosinophilic Asthma Treated with Benralizumab

Medical condition

Severe Eosinophilic Asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

Benralizumab

Sex

All

Estimated Enrollment

500

Study type

Interventional

Age

12 Years - 75 Years

Date

Study Start Date: 28 Feb 2024
Estimated Primary Completion Date: 31 Oct 2025
Estimated Study Completion Date: 31 Aug 2026

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria