BDB-001 Phase III Trial in ANCA-Associated Vasculitis

Официальное название

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

Обзор

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

Вмешательства

• Препарат BDB-001 injection
  Intravenously administered
• Препарат Cyclophosphamide
  Intravenously administered
• Биопрепарат Rituximab
  Intravenously administered
• Препарат Azathioprine
  Intravenously administered
• Препарат Prednisone
  Intravenously administered

Первичные конечные точки

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

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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；

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 65 центров

• Peking Union Medical College Hospital — Пекин
• Peking University People's Hospital — Пекин
• Peking University Third Hospital — Пекин
• Peking University International Hospital — Пекин
• Beijing Tsinghua Changgung Hospital — Пекин
• Peking University First Hospital — Пекин
• The Second Affiliated Hospital of Chongqing Medical University — Чунцин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• … и ещё 57 центров

Идентификаторы

NCT: NCT07168161 · STS-BDB001-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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