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

August 4, 2025 updated by: Staidson (Beijing) Biopharmaceuticals Co., Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The proportion of patients achieving disease complete remission or partial remission assessed by Birmingham Vasculitis Activity Score (BVAS)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The proportion of patients achieving disease complete remission assessed by Birmingham Vasculitis Activity Score (BVAS)
Time Frame: 12 weeks
12 weeks
Change from baseline in the Birmingham Vasculitis Activity Score (BVAS)
Time Frame: 4 weeks、8 weeks、12 weeks
4 weeks、8 weeks、12 weeks
Change from baseline in the Vasculitis Damage Index (VDI)
Time Frame: 12 weeks
12 weeks
Change from baseline in Estimated glomerular filtration rate (eGFR)、Urinary albumin:creatinine ratio (UACR)、Urine erythrocyte
Time Frame: 4 weeks、8 weeks、12 weeks
4 weeks、8 weeks、12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame: 0-24weeks
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.
Time Frame: 0-24weeks
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.
Time Frame: 0-12 weeks
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.
Time Frame: 0-12 weeks
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.
Time Frame: 0-12 weeks
Pharmacokinetic characteristics of BDB-001 injection in AAV patients were characterized based on population pharmacokinetic (PopPK) analysis.
0-12 weeks
Terminal phase half-life.
Time Frame: 0-12 weeks
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.
Time Frame: 0-12 weeks
0-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Staidson (Beijing) Biopharmaceuticals Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Minghui Zhao, Postdoc, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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