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

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.

Study Overview

• Status: Completed
• Conditions: ANCA-associated Vasculitis
• Intervention / Treatment: Drug: BDB-001 injection; Drug: Cyclophosphamide; Drug: Glucocorticoids

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; BDB-001 injection low dose plus reduced dose glucocorticoids in combination with cyclophosphamide	Drug: BDB-001 injection; Intravenously administered; Drug: Cyclophosphamide; Intravenously administered; Drug: Glucocorticoids; Orally administered; Other Names: Prednisone
Experimental: Group B; BDB-001 injection high dose plus reduced dose glucocorticoids in combination with cyclophosphamide	Drug: BDB-001 injection; Intravenously administered; Drug: Cyclophosphamide; Intravenously administered; Drug: Glucocorticoids; Orally administered; Other Names: Prednisone
Active Comparator: Group C; Standard dose glucocorticoids in combination with cyclophosphamide	Drug: Cyclophosphamide; Intravenously administered; Drug: Glucocorticoids; Orally administered; Other Names: Prednisone
Experimental: Group D; BDB-001 injection low dose in combination with cyclophosphamide	Drug: BDB-001 injection; Intravenously administered; Drug: Cyclophosphamide; Intravenously administered
Experimental: Group E; BDB-001 injection high dose in combination with cyclophosphamide	Drug: BDB-001 injection; Intravenously administered; Drug: Cyclophosphamide; Intravenously administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients achieving disease complete remission or partial remission assessed by Birmingham Vasculitis Activity Score (BVAS)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients achieving disease complete remission assessed by Birmingham Vasculitis Activity Score (BVAS)		12 weeks
Change from baseline in the Birmingham Vasculitis Activity Score (BVAS)		4 weeks、8 weeks、12 weeks
Change from baseline in the Vasculitis Damage Index (VDI)		12 weeks
Change from baseline in Estimated glomerular filtration rate (eGFR)、Urinary albumin:creatinine ratio (UACR)、Urine erythrocyte		4 weeks、8 weeks、12 weeks
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	0-24weeks
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	0-24weeks
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.	0-12 weeks
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.	0-12 weeks
Minimal Plasma Concentration (Cmin) of BDB-001.	Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.	0-12 weeks
Terminal phase half-life.	Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.	0-12 weeks
Change from baseline in C5a (mg/dL) concentration.		0-12 weeks

Collaborators and Investigators

• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Investigators: Principal Investigator: Minghui Zhao, Postdoc, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): March 19, 2025
• Study Completion (Actual): March 19, 2025

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Skin Diseases, Vascular; Systemic Vasculitis; Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Prednisone; Cyclophosphamide; Glucocorticoids
• Other Study ID Numbers: STS-BDB001-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No