Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis
- Conditions
- ANCA-associated Vasculitis
- Interventions
- Registration Number
- NCT05197842
- Lead Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 18 years old≤Age≤75 years old, male or female;
- Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA)；
- Newly diagnosed or relapsed GPA or MPA that requires treatment with cyclophosphamide(CYC) and glucocorticoids(GCs)；
- Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)；
- Estimated glomerular filtration rate ≥15 mL/minute/1.73 m^2；
- At least 1 major item, or at least 3 non-major items, or at least the 2 renal items on BVAS；
- Active tuberculosis infection;
- Severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage requiring pulmonary ventilation support, rapid-onset mononeuritis multiplex or central nervous system involvement；
- Any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus, IgA vasculitis (Henoch-Schönlein), rheumatoid vasculitis,anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis；
- HBsAg positive,or HBcAb positive and HBV-DNA positive；
- Received CYC within 3 months before the first administration or Received rituximab(RTX) within 12 months before the first administration；
- Received glucocorticoid shock therapy within 4 weeks before the first administration；
- Received an oral daily dose of a GC of > 10 mg prednisone-equivalent for more than 6 weeks continuously before the first administration；
- Received a anti-tumor necrosis factor and other biological agents treatment within 12 weeks before the first administration；
- Received Continuous dialysis treatment for 12 weeks or more before the first administration; Received Dialysis within 1 week before the first administration;
- Received intravenous immunoglobulin (Ig) or plasma exchange within 4 weeks before the first administration;
- Pregnant or lactating.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A BDB-001 injection BDB-001 injection low dose plus reduced dose glucocorticoids in combination with cyclophosphamide Group B BDB-001 injection BDB-001 injection high dose plus reduced dose glucocorticoids in combination with cyclophosphamide Group B Cyclophosphamide BDB-001 injection high dose plus reduced dose glucocorticoids in combination with cyclophosphamide Group B Glucocorticoids BDB-001 injection high dose plus reduced dose glucocorticoids in combination with cyclophosphamide Group A Cyclophosphamide BDB-001 injection low dose plus reduced dose glucocorticoids in combination with cyclophosphamide Group A Glucocorticoids BDB-001 injection low dose plus reduced dose glucocorticoids in combination with cyclophosphamide Group C Cyclophosphamide Standard dose glucocorticoids in combination with cyclophosphamide Group C Glucocorticoids Standard dose glucocorticoids in combination with cyclophosphamide Group D BDB-001 injection BDB-001 injection low dose in combination with cyclophosphamide Group D Cyclophosphamide BDB-001 injection low dose in combination with cyclophosphamide Group E BDB-001 injection BDB-001 injection high dose in combination with cyclophosphamide Group E Cyclophosphamide BDB-001 injection high dose in combination with cyclophosphamide
- Primary Outcome Measures
Name Time Method The proportion of patients achieving disease complete remission or partial remission assessed by Birmingham Vasculitis Activity Score (BVAS) 12 weeks
- Secondary Outcome Measures
Name Time Method The proportion of patients achieving disease complete remission assessed by Birmingham Vasculitis Activity Score (BVAS) 12 weeks Change from baseline in the Birmingham Vasculitis Activity Score (BVAS) 4 weeks、8 weeks、12 weeks Change from baseline in the Vasculitis Damage Index (VDI) 12 weeks Change from baseline in Estimated glomerular filtration rate (eGFR)、Urinary albumin:creatinine ratio (UACR)、Urine erythrocyte 4 weeks、8 weeks、12 weeks Number of Participants developing anti-BDB-001 antibodies. 0-24weeks Safety and tolerability indexes of BDB-001 injection for multiple administration of ANCA-associated vasculitis(AAV) patients
Area under the plasma concentration versus time curve (AUC) of BDB-001. 0-12 weeks Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.
Peak Plasma Concentration (Cmax) of BDB-001 and time to reach Cmax. 0-12 weeks Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. 0-24weeks Safety and tolerability indexes of BDB-001 injection for multiple administration of ANCA-associated vasculitis(AAV) patients
Minimal Plasma Concentration (Cmin) of BDB-001. 0-12 weeks Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.
Terminal phase half-life. 0-12 weeks Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.
Change from baseline in C5a (mg/dL) concentration. 0-12 weeks
Trial Locations
- Locations (22)
The Second hospital Of Anhui Medical University
🇨🇳Hefei, Anhui, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, 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
Peking University International Hospital
🇨🇳Beijing, Beijing, China
Xiangya Hospital Central South University (Nephrology Department)
🇨🇳Changsha, Hunan, China
Xiangya Hospital Central South University(Rheumatism Immunity Branch)
🇨🇳Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Tongji Hospital,Tongji Medical college of Hust
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
🇨🇳Shengyang, Liaoning, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Zhongshan hospital,Fudan University
🇨🇳Shanghai, Shanghai, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia Hui Autonomous Region(NHAR), China
Xijing Hospital
🇨🇳Xi'an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiao Tong University
🇨🇳Xi'an, Shanxi, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China