Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2026-01-11 @ 5:22 AM
Study NCT ID:
NCT07168161
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BDB-001 Phase III Trial in ANCA-Associated Vasculitis
Sponsor:
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Blind, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BDB-001 Injection in Patients With ANCA-Associated Vasculitis
Status:
RECRUITING
Status Verified Date:
2025-11
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:
None
Brief Summary:
The primary aim is to study the efficacy of treatment with BDB-001 Injection to induce remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: