BDB-001 Phase III Trial in ANCA-Associated Vasculitis

Official title

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

Overview

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

• Drug BDB-001 injection
  Intravenously administered
• Drug Cyclophosphamide
  Intravenously administered
• Biological Rituximab
  Intravenously administered
• Drug Azathioprine
  Intravenously administered
• Drug Prednisone
  Intravenously administered

Primary outcome measures

• The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS) [Time frame: Week 24]

Secondary outcome measures (9)

• The proportion of patients achieving disease sustained remission assessed by Birmingham Vasculitis Activity Score (BVAS) [Time frame: Week 48]
• Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission in the Study [Time frame: Week 48]
• Percentage of Participants With BVAS of 0 at Week 4 [Time frame: Week 4]
• In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Estimated glomerular filtration rate (eGFR) [Time frame: 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) [Time frame: Baseline, Week 4, 24 and 48]
• Glucocorticoid-induced Toxicity as Measured by Change From Baseline in the GTI [Time frame: Baseline, Week 24 and 48]
• Cumulative dose of glucocorticoids [Time frame: Week 24 and 48]
• Change from baseline in the Vasculitis Damage Index (VDI) [Time frame: 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 [Time frame: Baseline, Week 24 and 48]

Eligibility criteria

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 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；

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 65 centers

• Peking Union Medical College Hospital — Beijing
• Peking University People's Hospital — Beijing
• Peking University Third Hospital — Beijing
• Peking University International Hospital — Beijing
• Beijing Tsinghua Changgung Hospital — Beijing
• Peking University First Hospital — Beijing
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing
• The First Affiliated Hospital of Chongqing Medical University — Chongqing
• … and 57 more centers

Identifiers

NCT: NCT07168161 · STS-BDB001-10

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗