Efficacy and Safety of Partial Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the trial is to study the efficacy and safety of treatment with BDB-001 Injection partial substitution of glucocorticoid in patients with ANCA-associated vasculitis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Collaborator: Beijing Defengrei Biotechnology Co.,Ltd
• Treatments: Cyclophosphamide; Glucocorticoids; Prednisone

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 cyclophosphamide(CYC) and glucocorticoids(GCs)；

• Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)；

• Estimated glomerular filtration rate ≥20 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 or latent 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 multi-system autoimmune disease；

• Positive test for HBsAg or HBcAb；

• Received CYC within 6 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 treatment, any other experimental or biological therapy, intravenous immunoglobulin (Ig) or plasma exchange, antithymocyte globulin, required renal dialysis or kidney transplant within 12 weeks before the first administration；

• Pregnant or lactating.