Status:
COMPLETED
Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis
Lead Sponsor:
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Conditions:
ANCA-associated Vasculitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2025
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT05197842
Start Date
February 22 2022
End Date
March 19 2025
Last Update
August 7 2025
Active Locations (22)
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1
The Second hospital Of Anhui Medical University
Hefei, Anhui, China, 230601
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
3
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
4
Peking University International Hospital
Beijing, Beijing Municipality, China, 102206