STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma

Phase 3

Active, not recruiting

• Conditions: Severe Eosinophilic Asthma
• Interventions: Drug: Benralizumab

• Registration Number: NCT06465485
• Lead Sponsor: AstraZeneca

Brief Summary

This is a prospective, multi-center, single-arm Phase 3b study designed to evaluate the potential benefit to patients if benralizumab treatment could enable reduction in asthma maintenance controllers while allowing patients to maintain asthma control in Chinese patients.

Detailed Description

The study population will be approximately 200 patients on MD/HD ICS/LABA with and without LTRA or LAMA or theophylline and meeting study inclusion and exclusion criteria in China. After patients sign the informed consent, they will undergo a screening visit (Visit 1, Week -1 to Week 0) to assess eligibility criteria. Patients who meet eligibility criteria and complete study baseline assessments will enter the study and receive the first dose of benralizumab at visit 2 (Week 0).

The benralizumab treatment includes 4 phases: Induction Phase (16 weeks), Reduction Phase (24 weeks), Maintenance Phase (16 weeks) and Follow-up Phase (4 weeks). After initiation of benralizumab 30 mg administered subcutaneously every 4 weeks (Q4W) for the first 3 doses (Visits 2 to 4), then every 8 weeks (Q8W) thereafter.

Study Timeline

• Study First Submitted: 2024-02-01
• Study Start: 2024-02-28
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-18
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-09
• Last Update Posted: 2025-10-10
• Primary Completion: 2025-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Benralizumab	Benralizumab	Severe eosinophilic asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs will be all treated by study Drug.

Primary Outcome Measures

Name	Time	Method
To assess the potential for benralizumab treated patients to reduce their standard of care asthma controller regimen in the overall patient population and by subgroups of baseline background therapy Subgroups of background therapy	within 40 weeks after the first administration	Main outcomes: Proportion of patients with at least one controller medication category reduction at end of reduction phase; * discontinuation of LTRA, or; * discontinuation of LAMA, or; * getting to MD ICS/LABA or; * getting to LD ICS/LABA

Secondary Outcome Measures

Name	Time	Method
To assess standard asthma efficacy measures for benralizumab treated patients when reducing their standard of care asthma controller regimen for pulmonary function measured by pre-BD FEV1	From 16~40 weeks	Change in pre-BD FEV1 measured in litres from beginning of reduction phase to end of reduction phase \& FEV1 \< -100mL compared to beginning of reduction phase
To assess standard asthma efficacy measures for benralizumab treated patients when reducing their standard of care asthma controller regimen for asthma symptoms control measured by ACQ-5 & SGRQ Score	From 16~40 weeks	* Change in measured by ACQ-5 score \& SGRQ score from beginning of reduction phase to end of reduction phase; * Measured by Proportion of patients with no deterioration (defined as ACQ-5 score change \<0.5 score since last visit) during reduction phase
To assess standard asthma efficacy measures for benralizumab treated patients at induction phase in the overall patient population and by subgroups of baseline background therapy	within 0-16 weeks after first administration	* Change in measured by ACQ-IA score from beginning of induction phase to end of induction phase; * Measured by Proportion of patients achieving ACQ-IA score MCID improvement (defined as change in ACQ-IA score ≤-0.5 compared to beginning of induction phase) at end of induction phase
To assess overall asthma exacerbation rate during the study of severe eosinophilic asthma patients treated with benralizumab in the overall patient population and by subgroups of baseline background therapy	within 56 weeks after first administration	* Annualized asthma exacerbation rate during the study (from first dose to EOT) and 1-year baseline period; * Change in annualized asthma exacerbation rate during study phase vs. 1-year baseline period; Annualized asthma exacerbation rate Defined as Number of exacerbations×365.25/(Follow-Up Date-First Benralizumab dose date+1)
To assess biomarkers of severe eosinophilic asthma patients treated with benralizumab in the overall patient population and by subgroups of baseline background therapy	from -1 week to 56 week	Baseline and follow-up visits, and change from baseline:· IgE measured as per
To assess the safety and tolerability of benralizumab during the study in patients with severe eosinophilic asthma, while reducing their standard of care asthma controller regimen and maintaining asthma symptom control.	from -1 week to 60 week	* Frequency of Adverse Events/Serious Adverse Events; * Vital Signsa; * Laboratory variables (chemistry and hematology)

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhengzhou, China