BDB-001 for adults with ANCA-associated vasculitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III interventional trial gives BDB-001 injections together with standard induction regimens—either cyclophosphamide followed by azathioprine or rituximab—to adults with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Eligible patients are 18–75 years old, PR3- or MPO-positive, meet defined BVAS activity thresholds, and have an eGFR ≥15 mL/min/1.73 m2. The study is designed to determine whether adding BDB-001 improves rates of remission compared with standard therapy while monitoring safety and tolerability. Trial sites are at three major hospitals in Beijing where participants will attend regular study visits for treatment and follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hunan Provincial People's Hospital
  Changsha, Hunan, China Recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Peking University People's Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Peking University International Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Beijing Tsinghua Changgung Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

+15 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Minghui Zhao, M.D. — Peking University First Hospital
• Study coordinator: Aiping Sun
• Email: sunaiping@staidson.com
• Phone: +86 010-67519614

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.