BDB-001 Phase III Trial in ANCA-Associated Vasculitis

Staidson Biopharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: ANCA Associated Vasculitis (AAV)

Treatments: Drug: BDB-001 injection; Drug: Cyclophosphamide; Drug: Prednisone; Drug: Azathioprine; Biological: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07168161

STS-BDB001-10

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years old≤Age≤75 years old, male or female;
2. Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA)；
3. Newly diagnosed or relapsed GPA or MPA that requires treatment with a full starting dose of prednisone plus cyclophosphamide/azathioprine or rituximab；
4. Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)；
5. Estimated glomerular filtration rate ≥15 mL/minute/1.73 m^2；
6. At least 1 major item, or at least 3 non-major items, or at least the 2 renal items on BVAS；

Exclusion criteria

1. Active tuberculosis infection;
2. alveolar hemorrhage requiring pulmonary ventilation support；
3. 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；
4. HBsAg positive,or HBcAb positive and HBV-DNA positive；
5. Received CYC within 3 months before the first administration or Received rituximab(RTX) within 12 months before the first administration；
6. Received glucocorticoid shock therapy within 4 weeks before the first administration；
7. Received an oral daily dose of a GC of > 10 mg prednisone-equivalent for more than 6 weeks continuously before the first administration；
8. Received a anti-tumor necrosis factor and other biological agents treatment within 12 weeks before the first administration；
9. Received Continuous dialysis treatment for 12 weeks or more before the first administration; Received Dialysis within 1 week before the first administration;
10. Received intravenous immunoglobulin (Ig) or plasma exchange within 4 weeks before the first administration;
11. Pregnant or lactating.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

BDB-001 injection group

Experimental group

Description:

BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.

Treatment:

Biological: Rituximab

Drug: Azathioprine

Drug: Cyclophosphamide

Drug: BDB-001 injection

Prednisone group

Active Comparator group

Description:

BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.

Treatment:

Biological: Rituximab

Drug: Azathioprine

Drug: Prednisone

Drug: Cyclophosphamide