Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis

Plain-language summary

This study evaluated the efficacy and safety of using BDB-001 injection in place of standard glucocorticoid treatment in patients with ANCA-associated vasculitis (an inflammatory blood-vessel disease). It enrolled patients aged 18-75 with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) who required treatment with cyclophosphamide. The study was carried out in Phase 1/Phase 2 and has been completed.

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

Trial details

Phase

PHASE1/PHASE2

Status

Completed

Sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Intervention

BDB-001 injection, Cyclophosphamide, Glucocorticoids

Start date

2/22/2022

Estimated completion

3/19/2025

Countries

China

Related genes

Locations

• Hefei, China
• Beijing, China
• Beijing, China
• Beijing, China
• Nanning, China
• Shijiazhuang, China
• Shijiazhuang, China
• Luoyang, China
• Zhengzhou, China
• Wuhan, China
• Changsha, China
• Changsha, China
• Changsha, China
• Nanchang, China
• Shengyang, China
• Shenyang, China
• Yinchuan, China
• Shanghai, China
• Xi’an, China
• Xi’an, China
• Tianjin, China
• Hangzhou, China

Eligibility criteria

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

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.