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CompletedNCT05197842Updated Aug 7, 2025

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

A Phase 1/2 interventional study of BDB-001 injection and Cyclophosphamide in ANCA-associated Vasculitis, sponsored by Staidson (Beijing) Biopharmaceuticals Co., Ltd. Completed at 22 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-07.

Sponsored by Staidson (Beijing) Biopharmaceuticals Co., Ltd · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The aim of the trial is to study the efficacy and safety of treatment with BDB-001 Injection substitution of glucocorticoid in patients with ANCA-associated vasculitis.

02

Conditions studied

  • ANCA-associated Vasculitis
03

In context

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

139 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 71 are open to participants now.

This study's enrollment of 93 is above the median of 32 across 103 interventional studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.

Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →

Lead sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    Group A

    BDB-001 injection low dose plus reduced dose glucocorticoids in combination with cyclophosphamide

    Drug: BDB-001 injection · Drug: Cyclophosphamide · Drug: Glucocorticoids

  • Experimental
    Group B

    BDB-001 injection high dose plus reduced dose glucocorticoids in combination with cyclophosphamide

    Drug: BDB-001 injection · Drug: Cyclophosphamide · Drug: Glucocorticoids

  • Active comparator
    Group C

    Standard dose glucocorticoids in combination with cyclophosphamide

    Drug: Cyclophosphamide · Drug: Glucocorticoids

  • Experimental
    Group D

    BDB-001 injection low dose in combination with cyclophosphamide

    Drug: BDB-001 injection · Drug: Cyclophosphamide

  • Experimental
    Group E

    BDB-001 injection high dose in combination with cyclophosphamide

    Drug: BDB-001 injection · Drug: Cyclophosphamide

Interventions

  • DrugBDB-001 injection

    Intravenously administered

  • DrugCyclophosphamide

    Intravenously administered

  • DrugGlucocorticoids

    Orally administered

    Also known as: Prednisone

06

What researchers measure

Primary outcomes

  1. The proportion of patients achieving disease complete remission or partial remission assessed by Birmingham Vasculitis Activity Score (BVAS)

    Time frame: 12 weeks

Secondary outcomes

  1. The proportion of patients achieving disease complete remission assessed by Birmingham Vasculitis Activity Score (BVAS)

    Time frame: 12 weeks

  2. Change from baseline in the Birmingham Vasculitis Activity Score (BVAS)

    Time frame: 4 weeks、8 weeks、12 weeks

  3. Change from baseline in the Vasculitis Damage Index (VDI)

    Time frame: 12 weeks

  4. Change from baseline in Estimated glomerular filtration rate (eGFR)、Urinary albumin:creatinine ratio (UACR)、Urine erythrocyte

    Time frame: 4 weeks、8 weeks、12 weeks

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

    Safety and tolerability indexes of BDB-001 injection for multiple administration of ANCA-associated vasculitis(AAV) patients

    Time frame: 0-24weeks

  6. Number of Participants developing anti-BDB-001 antibodies.

    Safety and tolerability indexes of BDB-001 injection for multiple administration of ANCA-associated vasculitis(AAV) patients

    Time frame: 0-24weeks

  7. Area under the plasma concentration versus time curve (AUC) of BDB-001.

    Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.

    Time frame: 0-12 weeks

  8. Peak Plasma Concentration (Cmax) of BDB-001 and time to reach Cmax.

    Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.

    Time frame: 0-12 weeks

  9. Minimal Plasma Concentration (Cmin) of BDB-001.

    Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.

    Time frame: 0-12 weeks

  10. Terminal phase half-life.

    Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.

    Time frame: 0-12 weeks

  11. Change from baseline in C5a (mg/dL) concentration.

    Time frame: 0-12 weeks

07

Study locations

22 sites
  • The Second hospital Of Anhui Medical University
    Hefei, Anhui 230601, China
  • Peking Union Medical College Hospital
    Beijing, Beijing Municipality 100005, China
  • Peking University First Hospital
    Beijing, Beijing Municipality 100034, China
  • Peking University International Hospital
    Beijing, Beijing Municipality 102206, China
  • Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region
    Nanning, Guangxi Zhuang Autonomous Region (gzar) 530016, China
  • The Second hospital of Hebei Medical University
    Shijiazhuang, Hebei 050004, China
  • The Third hospital of Hebei Medical University
    Shijiazhuang, Hebei 050051, China
  • The First Affiliated Hospital of Henan University of science and Technology
    Luoyang, Henan 471003, China
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450052, China
  • Tongji Hospital,Tongji Medical college of Hust
    Wuhan, Hubei 100005, China
  • Xiangya Hospital Central South University (Nephrology Department)
    Changsha, Hunan 410008, China
  • Xiangya Hospital Central South University(Rheumatism Immunity Branch)
    Changsha, Hunan 410008, China
  • The Third Xiangya Hospital of Central South University
    Changsha, Hunan 410205, China
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330006, China
  • Shengjing Hospital of China Medical University
    Shengyang, Liaoning 110004, China
  • The First Hospital of China Medical University
    Shenyang, Liaoning 110001, China
  • General Hospital of Ningxia Medical University
    Yinchuan, Ningxia Hui Autonomous Region(NHAR) 750003, China
  • Zhongshan hospital,Fudan University
    Shanghai, Shanghai Municipality 200032, China
  • Xijing Hospital
    Xi’an, Shanxi 710032, China
  • The First Affiliated Hospital of Xi'an Jiao Tong University
    Xi’an, Shanxi 710061, China
  • Tianjin Medical University General Hospital
    Tianjin, Tianjin Municipality 300052, China
  • The First Affiliated Hospital, College of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310003, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05197842
Lead sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Responsible party
Sponsor
First posted
Jan 20, 2022
Start date
Feb 22, 2022
Primary completion
Mar 19, 2025
Completion
Mar 19, 2025
Last update
Aug 7, 2025

Study contacts

Minghui Zhao, Postdoc
principal investigator · Peking University First Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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