ANCA Associated Vasculitis (AAV)
Conditions
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
Interventions
Intravenously administered
DRUGCyclophosphamide
Intravenously administered
DRUGRituximab
Intravenously administered
DRUGAzathioprine
Intravenously administered
DRUGPrednisone
Intravenously administered
Sponsors
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18 years old≤Age≤75 years old, male or female; 2. Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA)； 3. Newly diagnosed or relapsed GPA or MPA that requires treatment with a full starting dose of prednisone plus cyclophosphamide/azathioprine or rituximab； 4. Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)； 5. Estimated glomerular filtration rate ≥15 mL/minute/1.73 m\^2； 6. At least 1 major item, or at least 3 non-major items, or at least the 2 renal items on BVAS；
Exclusion criteria
1. Active tuberculosis infection; 2. alveolar hemorrhage requiring pulmonary ventilation support； 3. History of any malignancy of any organ system within 5 years prior to the first dose, except for basal cell carcinoma of the skin or carcinoma in situ (e.g., cervical or breast carcinoma in situ) that has been completely resected and shows no evidence of local recurrence or metastasis. 4. 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； 5. HBsAg positive,or HBcAb positive and HBV-DNA positive； 6. Received CYC within 3 months before the first administration or Received rituximab(RTX) or other B-cell antibody within 12 months before the first administration； 7. Received glucocorticoid shock therapy within 4 weeks before the first administration； 8. Received an oral daily dose of a GC of \> 10 mg prednisone-equivalent for more than 6 weeks continuously before the first administration； 9. Received a anti-tumor necrosis factor and other biological agents treatment within 12 weeks before the first administration； 10. Received Continuous dialysis treatment for 12 weeks or more before the first administration; Received Dialysis within 1 week before the first administration; 11. Received intravenous immunoglobulin (Ig) or plasma exchange within 4 weeks before the first administration; 12. Pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS) | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving disease sustained remission assessed by Birmingham Vasculitis Activity Score (BVAS) | Week 48 |
| Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission in the Study | Week 48 |
| Percentage of Participants With BVAS of 0 at Week 4 | Week 4 |
| In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Estimated glomerular filtration rate (eGFR) | Baseline, Week 24 and Week 48 |
| In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Urinary albumin:creatinine ratio (UACR) | Baseline, Week 4, 24 and 48 |
| Glucocorticoid-induced Toxicity as Measured by Change From Baseline in the GTI | Baseline, Week 24 and 48 |
| Cumulative dose of glucocorticoids | Week 24 and 48 |
| Change from baseline in the Vasculitis Damage Index (VDI) | Baseline, Week 24 and 48 |
| Change From Baseline in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36 | Baseline, Week 24 and 48 |
Countries
China
Contacts
CONTACTAiping Sun
PRINCIPAL_INVESTIGATORMinghui Zhao, M.D.
Peking University First Hospital
Outcome results
None listed