Evaluating a new injection for treating ANCA-associated vasculitis

A Multicenter, Randomized, Open-lable, Parallel-controlled, Phase I/II Trial to Study Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With ANCA-associated Vasculitis

This study is testing a new injection called BDB-001 to see if it can safely replace glucocorticoids for people with ANCA-associated vasculitis.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd (Industry-sponsored)
• Drugs / interventions: rituximab, cyclophosphamide, prednisone
• Locations: 22 sites (Hefei, Anhui and 21 other locations)
• Trial ID: NCT05197842 on ClinicalTrials.gov

What this trial studies

This trial investigates the efficacy and safety of BDB-001 injection as a substitute for glucocorticoids in patients diagnosed with ANCA-associated vasculitis, specifically granulomatosis with polyangiitis or microscopic polyangiitis. Participants will receive BDB-001 alongside cyclophosphamide and glucocorticoids to assess its effectiveness in managing their condition. The study aims to determine if this new treatment can provide a safer or more effective alternative to traditional glucocorticoid therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with newly diagnosed or relapsed granulomatosis with polyangiitis or microscopic polyangiitis requiring treatment.

Not a fit: Patients with active tuberculosis, severe disease manifestations, or other multi-system autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a safer and more effective option for patients suffering from ANCA-associated vasculitis.

How similar studies have performed: While this approach is novel, similar studies exploring alternative treatments for ANCA-associated vasculitis have shown promise, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 21 other locations

• The Second hospital Of Anhui Medical University — Hefei, Anhui, China (Not_yet_recruiting)
• Peking Union Medical College Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Peking University First Hospital — Beijing, Beijing, China (Recruiting)
• Peking University International Hospital — Beijing, Beijing, 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)
• The Second hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• The Third hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• The First Affiliated Hospital of Henan University of science and Technology — Luoyang, Henan, China (Active_not_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)
• 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)
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Active_not_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shengyang, Liaoning, China (Not_yet_recruiting)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• General Hospital of Ningxia Medical University — Yinchuan, Ningxia Hui Autonomous Region(NHAR), China (Not_yet_recruiting)
• Zhongshan hospital,Fudan University — Shanghai, Shanghai, China (Not_yet_recruiting)
• Xijing Hospital — Xi'an, Shanxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiao Tong University — Xi'an, Shanxi, China (Not_yet_recruiting)
• Tianjin Medical University General Hospital — Tianjin, Tianjin, China (Active_not_recruiting)
• The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Minghui Zhao, Postdoc — Peking University First Hospital
• Study coordinator: Zheng Xiaohong

Conditions ANCA-associated Vasculitis