BDB-001 for adults with ANCA-associated vasculitis

A Multicenter, Randomized, Double-Blind, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BDB-001 Injection in Patients With ANCA-Associated Vasculitis

This trial will test whether adding the experimental drug BDB-001 to standard induction therapy (cyclophosphamide then azathioprine, or rituximab) helps adults with active ANCA-associated vasculitis achieve remission.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd (Industry-sponsored)
• Drugs / interventions: rituximab, cyclophosphamide, prednisone
• Locations: 60 sites (Beijing, Beijing Municipality and 59 other locations)
• Trial ID: NCT07168161 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with newly diagnosed or relapsed GPA or MPA who are PR3- or MPO-positive, require full-dose induction with prednisone plus cyclophosphamide/azathioprine or rituximab, have eGFR ≥15, and meet the trial's BVAS activity criteria.

Not a fit: Patients with active tuberculosis, alveolar hemorrhage requiring ventilatory support, recent malignancy within five years, or other major exclusionary conditions are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, BDB-001 could help more patients achieve remission and may reduce the need for prolonged high-dose steroids.

How similar studies have performed: Earlier-phase studies of BDB-001 or similar biologic approaches have suggested potential benefit, but this Phase III trial is needed to confirm efficacy and safety.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 59 other locations

• 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)
• Peking University First Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Not_yet_recruiting)
• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Not_yet_recruiting)
• Guangdong General Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Meizhou People's Hospital — Meizhou, Guangdong, China (Not_yet_recruiting)
• Yuebei People's Hospital — Shaoguan, Guangdong, China (Not_yet_recruiting)
• Guangdong Provincial People's Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• Peking university Shenzhen Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• Liuzhou People's Hospital — Liuzhou, Guangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Not_yet_recruiting)
• Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi Zhuang Autonomous Region (gzar), China (Not_yet_recruiting)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (Not_yet_recruiting)
• Cangzhou City People's Hospital — Cangzhou, Hebei, China (Not_yet_recruiting)
• The Second Hospital of Hebei Medical University City:Shijiazhuang — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Kailuan General Hospital — Tangshan, Hebei, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Harbin — Harbin, Heilongjiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Henan University of science and Technology — Luoyang, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Tongji Hospital,Tongji Medical college of Hust — Wuhan, Hubei, China (Not_yet_recruiting)
• Yichang Central People's Hospital — Yichang, Hubei, China (Not_yet_recruiting)
• General Hospital of Hunan University of Medicine — Changde, Hunan, China (Not_yet_recruiting)
• Hunan Provincial People's Hospital — Changsha, Hunan, China (Recruiting)
• Xiangya Hospital Central South University (Nephrology Department) — Changsha, Hunan, China (Not_yet_recruiting)
• Xiangya Hospital Central South University(Rheumatism Immunity Branch) — Changsha, Hunan, China (Not_yet_recruiting)
• General Hospital of Hunan University of Medicine — Huaihua, Hunan, China (Not_yet_recruiting)
• Zhuzhou Central Hospital — Zhuzhou, Hunan, China (Not_yet_recruiting)
• Nanjing Gulou Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Nanjing University School of Medicine Affiliated Gulou Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• Jiangxi Provincial People's Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The Second Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Affiliated Hospital of Yanbian University (Yanbian Hospital) — Yanbian, Jilin, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shengyang, Liaoning, China (Not_yet_recruiting)
• Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Neimenggu, China (Not_yet_recruiting)
• Shandong Provincial Hospital — Jinan, Shandong, China (Not_yet_recruiting)
• Weifang People's Hospital — Weifang, Shandong, China (Not_yet_recruiting)
• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Zhongshan hospital,Fudan University — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)
• The Second Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Not_yet_recruiting)
• Xijing Hospital — Xi’an, Shanxi, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Minghui Zhao, M.D. — Peking University First Hospital
• Study coordinator: Aiping Sun

Conditions ANCA Associated Vasculitis