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

Staidson Biopharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: ANCA-associated Vasculitis

Treatments: Drug: Glucocorticoids; Drug: Cyclophosphamide; Drug: BDB-001 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05197842

STS-BDB001-07

Details and patient eligibility

About

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

Enrollment: 93 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 ≥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;
• 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 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) 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 5 patient groups

Group A

Experimental group

Description:

BDB-001 injection low dose plus reduced dose glucocorticoids in combination with cyclophosphamide

Treatment:

Drug: BDB-001 injection

Drug: Cyclophosphamide

Drug: Glucocorticoids

Group B

Experimental group

Description:

BDB-001 injection high dose plus reduced dose glucocorticoids in combination with cyclophosphamide

Treatment:

Drug: BDB-001 injection

Drug: Cyclophosphamide

Drug: Glucocorticoids

Group C

Active Comparator group

Description:

Standard dose glucocorticoids in combination with cyclophosphamide

Treatment:

Drug: Cyclophosphamide

Drug: Glucocorticoids

Group D

Experimental group

Description:

BDB-001 injection low dose in combination with cyclophosphamide

Treatment:

Drug: BDB-001 injection

Drug: Cyclophosphamide

Group E

Experimental group

Description:

BDB-001 injection high dose in combination with cyclophosphamide

Treatment:

Drug: BDB-001 injection

Drug: Cyclophosphamide