ANCA-associated Vasculitis
Conditions
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.
Interventions
Intravenously administered
DRUGCyclophosphamide
Intravenously administered
DRUGGlucocorticoids
Orally administered
Sponsors
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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；
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving disease complete remission or partial remission assessed by Birmingham Vasculitis Activity Score (BVAS) | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| The proportion of patients achieving disease complete remission assessed by Birmingham Vasculitis Activity Score (BVAS) | 12 weeks | — |
| 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. |
| 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 | — |
| 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. |
Countries
China
Outcome results
None listed