Ignite Creation Date:
2024-07-17 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465485
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-02-01
Brief Title:
STEP Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP
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 480 patients on MDHD ICSLABA 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None