BDB-001 Phase III Trial in ANCA-Associated Vasculitis

Plain-language summary

This study evaluates BDB-001 injection together with standard treatments (corticosteroids and immunosuppressive drugs) in patients with ANCA-associated vasculitis, an autoimmune disease involving inflammation of blood vessels. Patients aged 18 to 75 diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) may take part. The study is being conducted in Phase 3 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Recruiting

Sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Intervention

BDB-001 injection, Cyclophosphamide, Rituximab, Azathioprine, Prednisone

Start date

11/10/2025

Estimated completion

2/29/2028

Countries

China

Related genes

Locations

• Beijing, China
• Beijing, China
• Beijing, China
• Beijing, China
• Beijing, China
• Beijing, China
• Chongqing, China
• Chongqing, China
• Xiamen, China
• Lanzhou, China
• Guangzhou, China
• Guangzhou, China
• Meizhou, China
• Shaoguan, China
• Shenzhen, China
• Shenzhen, China
• Liuzhou, China
• Nanning, China
• Nanning, China
• Guiyang, China
• Cangzhou, China
• Shijiazhuang, China
• Tangshan, China
• Harbin, China
• Luoyang, China
• Zhengzhou, China
• Wuhan, China
• Yichang, China
• Changde, China
• Changsha, China
• Changsha, China
• Changsha, China
• Huaihua, China
• Zhuzhou, China
• Nanjing, China
• Nanjing, China
• Xuzhou, China
• Nanchang, China
• Nanchang, China
• Changchun, China

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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