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ANCA-associated VasculitisPhase 1/2NCT05197842

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 study testing BDB-001 injection, Cyclophosphamide and Glucocorticoids in people with ANCA-associated Vasculitis, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 22 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
ANCA-associated Vasculitis
What is being tested?
BDB-001 injection, Cyclophosphamide and Glucocorticoids
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
22 sitesChina
Study dates
22 Feb 2022to 19 Mar 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；

Who cannot join

  • 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；
Show all 11Show fewer
  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

China22 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100005

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University International Hospital

    Beijing, Beijing Municipality, 102206

  • Xiangya Hospital Central South University (Nephrology Department)

    Changsha, Hunan, 410008

  • Xiangya Hospital Central South University(Rheumatism Immunity Branch)

    Changsha, Hunan, 410008

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410205

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • The Second hospital Of Anhui Medical University

    Hefei, Anhui, 230601

  • The First Affiliated Hospital of Henan University of science and Technology

    Luoyang, Henan, 471003

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi Zhuang Autonomous Region (gzar), 530016

  • Zhongshan hospital,Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shengjing Hospital of China Medical University

    Shengyang, Liaoning, 110004

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • The Second hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050004

  • The Third hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tongji Hospital,Tongji Medical college of Hust

    Wuhan, Hubei, 100005

  • Xijing Hospital

    Xi’an, Shanxi, 710032

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi’an, Shanxi, 710061

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia Hui Autonomous Region(NHAR), 750003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: 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.

Being tested
BDB-001 injection, Cyclophosphamide, Glucocorticoids
Medical subject headings
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BDB-001 injectionDrug

    Intravenously administered

  • CyclophosphamideDrug

    Intravenously administered

  • GlucocorticoidsDrug

    Also called Prednisone

    Orally administered

Study groups in NCT05197842
Study groupRoleWhat they receive
Group AExperimentalBDB-001 injection low dose plus reduced dose glucocorticoids in combination with cyclophosphamide
Receives: Drug: BDB-001 injection; Drug: Cyclophosphamide; Drug: Glucocorticoids
Group BExperimentalBDB-001 injection high dose plus reduced dose glucocorticoids in combination with cyclophosphamide
Receives: Drug: BDB-001 injection; Drug: Cyclophosphamide; Drug: Glucocorticoids
Group CActive comparatorStandard dose glucocorticoids in combination with cyclophosphamide
Receives: Drug: Cyclophosphamide; Drug: Glucocorticoids
Group DExperimentalBDB-001 injection low dose in combination with cyclophosphamide
Receives: Drug: BDB-001 injection; Drug: Cyclophosphamide
Group EExperimentalBDB-001 injection high dose in combination with cyclophosphamide
Receives: Drug: BDB-001 injection; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 weeks

Secondary outcomes (11)

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

    Measured: 12 weeks

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

    Measured: 4 weeks、8 weeks、12 weeks

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

    Measured: 12 weeks

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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 0-12 weeks

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

    Measured: 0-12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2022
  2. Study start22 Feb 2022
  3. Primary completion19 Mar 2025
  4. Study completion19 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05197842
Sponsor's protocol ID
STS-BDB001-07
Status last verified
Aug 2025
First submitted
2 Dec 2021
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BDB-001 injection, Cyclophosphamide and Glucocorticoids in people with ANCA-associated Vasculitis, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 22 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients achieving disease complete remission or partial remission assessed by Birmingham Vasculitis Activity Score (BVAS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05197842.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.

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