A Multicenter, Randomized, Double-Blind, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BDB-001 Injection in Patients With ANCA-Associated Vasculitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 64
- 主要终点
- The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 a full starting dose of prednisone plus cyclophosphamide/azathioprine or rituximab；
- •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；
排除标准
- •Active tuberculosis infection;
- •alveolar hemorrhage requiring pulmonary ventilation support；
- •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.
- •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) or other B-cell antibody 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.
研究组 & 干预措施
BDB-001 injection group
BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
干预措施: BDB-001 injection (Drug)
Prednisone group
BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.
干预措施: Prednisone (Drug)
BDB-001 injection group
BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
干预措施: Cyclophosphamide (Drug)
BDB-001 injection group
BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
干预措施: Rituximab (Drug)
BDB-001 injection group
BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
干预措施: Azathioprine (Drug)
Prednisone group
BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.
干预措施: Cyclophosphamide (Drug)
Prednisone group
BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.
干预措施: Rituximab (Drug)
Prednisone group
BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.
干预措施: Azathioprine (Drug)
结局指标
主要结局
The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS)
时间窗: Week 24
The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS)
时间窗: Week 24
次要结局
- 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)
- Cumulative dose of glucocorticoids(Week 24 and 48)
- 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)
- 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)