The aim of the trial is to study the efficacy and safety of treatment with BDB-001 Injection substitution of glucocorticoid in patients with ANCA-associated vasculitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Intravenously administered
Intravenously administered
Orally administered
The Second hospital Of Anhui Medical University
The proportion of patients achieving disease complete remission or partial remission assessed by Birmingham Vasculitis Activity Score (BVAS)
Time frame: 12 weeks
The proportion of patients achieving disease complete remission assessed by Birmingham Vasculitis Activity Score (BVAS)
Time frame: 12 weeks
Change from baseline in the Birmingham Vasculitis Activity Score (BVAS)
Time frame: 4 weeks、8 weeks、12 weeks
Change from baseline in the Vasculitis Damage Index (VDI)
Time frame: 12 weeks
Change from baseline in Estimated glomerular filtration rate (eGFR)、Urinary albumin:creatinine ratio (UACR)、Urine erythrocyte
Time frame: 4 weeks、8 weeks、12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Safety and tolerability indexes of BDB-001 injection for multiple administration of ANCA-associated vasculitis(AAV) patients
Time frame: 0-24weeks
Number of Participants developing anti-BDB-001 antibodies.
Safety and tolerability indexes of BDB-001 injection for multiple administration of ANCA-associated vasculitis(AAV) patients
Time frame: 0-24weeks
Area under the plasma concentration versus time curve (AUC) of BDB-001.
Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.
Time frame: 0-12 weeks
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Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi Zhuang Autonomous Region (gzar), China
The Second hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Third hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital,Tongji Medical college of Hust
Wuhan, Hubei, China
...and 12 more locations
Peak Plasma Concentration (Cmax) of BDB-001 and time to reach Cmax.
Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.
Time frame: 0-12 weeks
Minimal Plasma Concentration (Cmin) of BDB-001.
Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.
Time frame: 0-12 weeks
Terminal phase half-life.
Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.
Time frame: 0-12 weeks
Change from baseline in C5a (mg/dL) concentration.
Time frame: 0-12 weeks