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
- Registration Number
- NCT05197842
- Lead Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria:<br><br> - 18 years old=Age=75 years old, male or female;<br><br> - Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA);<br><br> - Newly diagnosed or relapsed GPA or MPA that requires treatment with<br> cyclophosphamide(CYC) and glucocorticoids(GCs);<br><br> - Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO);<br><br> - Estimated glomerular filtration rate =15 mL/minute/1.73 m^2;<br><br> - At least 1 major item, or at least 3 non-major items, or at least the 2 renal items<br> on BVAS;<br><br>Exclusion Criteria:<br><br> - Active tuberculosis infection;<br><br> - Severe disease as determined by rapidly progressive glomerulonephritis, alveolar<br> hemorrhage requiring pulmonary ventilation support, rapid-onset mononeuritis<br> multiplex or central nervous system involvement;<br><br> - Any other known multi-system autoimmune disease including eosinophilic<br> granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus, IgA<br> vasculitis (Henoch-Schönlein), rheumatoid vasculitis,anti-glomerular basement<br> membrane disease, or cryoglobulinemic vasculitis;<br><br> - HBsAg positive,or HBcAb positive and HBV-DNA positive;<br><br> - Received CYC within 3 months before the first administration or Received<br> rituximab(RTX) within 12 months before the first administration;<br><br> - Received glucocorticoid shock therapy within 4 weeks before the first<br> administration;<br><br> - Received an oral daily dose of a GC of > 10 mg prednisone-equivalent for more than 6<br> weeks continuously before the first administration;<br><br> - Received a anti-tumor necrosis factor and other biological agents treatment within<br> 12 weeks before the first administration;<br><br> - Received Continuous dialysis treatment for 12 weeks or more before the first<br> administration; Received Dialysis within 1 week before the first administration;<br><br> - Received intravenous immunoglobulin (Ig) or plasma exchange within 4 weeks before<br> the first administration;<br><br> - Pregnant or lactating.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients achieving disease complete remission or partial remission assessed by Birmingham Vasculitis Activity Score (BVAS)
- Secondary Outcome Measures
Name Time Method The proportion of patients achieving disease complete remission assessed by Birmingham Vasculitis Activity Score (BVAS);Change from baseline in the Birmingham Vasculitis Activity Score (BVAS);Change from baseline in the Vasculitis Damage Index (VDI);Change from baseline in Estimated glomerular filtration rate (eGFR)?Urinary albumin:creatinine ratio (UACR)?Urine erythrocyte;Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.;Number of Participants developing anti-BDB-001 antibodies.;Area under the plasma concentration versus time curve (AUC) of BDB-001.;Peak Plasma Concentration (Cmax) of BDB-001 and time to reach Cmax.;Minimal Plasma Concentration (Cmin) of BDB-001.;Terminal phase half-life.;Change from baseline in C5a (mg/dL) concentration.