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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06465485
Other study ID # D3250L00046
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 28, 2024
Est. completion date July 31, 2026

Study information

Verified date June 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Benralizumab
Severe eosinophilic asthma taking medium-high dose ICS/LABA with/without LTRAs, LAMAs or theophylline will be enrolled into this single arm treatment.

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Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the potential for benralizumab treated patients to reduce their standard of care asthma controller regimen 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
discontinuation of theophylline, or
getting to MD ICS/LABA, or
getting to LD ICS/LABA
Supportive outcomes:
Proportion of patients with individual category reduction at end of reduction phase
Proportion of patients with =2 category reductions in controller medication
In sub-group of patients who meet reduction criteria
proportion of patients with at least one controller medication category reduction,
proportion of patients with individual category reduction
proportion of patients with =2 reductions in controller medication at end of reduction phase
within 40 weeks after the first administration
Secondary 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 in litres Change in pre-BD FEV1 measured in litres from beginning of reduction phase to end of reduction phase From 16~40 weeks
Secondary 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-IA Score Change in measured by ACQ-IA score from beginning of reduction phase to end of reduction phase
Measured by Proportion of patients with no deterioration (defined as ACQ-IA score change <0.5 score since last visit) during reduction phase
From 16~40 weeks
Secondary To assess if reductions in background therapies achieved at end of reduction phase are maintained until end of maintenance phase Measured by Proportion of patients at the end of the maintenance phase who use the same background therapy that they achieved at the end of the reduction phase from 40-56 weeks
Secondary To assess if reductions in background therapies achieved at end of reduction phase are maintained until end of maintenance phase Change in measured by ACQ-IA score from the end of the reduction phase to the end of the maintenance phase from 40-56 weeks
Secondary To assess if reductions in background therapies achieved at end of reduction phase are maintained until end of maintenance phase Change in measured by FEV1 in litres from the end of the reduction phase to the end of the maintenance phase from 40-56 weeks
Secondary To assess standard asthma efficacy measures for benralizumab treated patients at induction phase Change in measured by FEV1 in litres from beginning of induction phase to end of induction phase within 0-16 weeks after first administration
Secondary To assess standard asthma efficacy measures for benralizumab treated patients at induction phase 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
within 0-16 weeks after first administration
Secondary To assess overall asthma exacerbation rate during the study of severe eosinophilic asthma patients treated with benralizumab 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)
within 56 weeks after first administration
Secondary To assess biomarkers of severe eosinophilic asthma patients treated with benralizumab Baseline and follow-up visits, and change from baseline:
Blood EOS measured as cells per litre
from -1 week to 56 week
Secondary To assess biomarkers of severe eosinophilic asthma patients treated with benralizumab Baseline and follow-up visits, and change from baseline:· FeNO measured as parts per billion from -1 week to 56 week
Secondary To assess the safety and tolerability of benralizumab.Number of participants with treatment-related adverse events as asessed by CTCAEV5.0. The number of patients experiencing any Treatment related AEs/SAEs from -1 week to 60 week
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