RecruitingPhase 3

BDB-001 Phase III Trial in ANCA-Associated Vasculitis

China300 participantsStarted 2025-11-10

Plain-language summary

The primary aim is to study the efficacy of treatment with BDB-001 Injection to induce remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 a full starting dose of prednisone plus cyclophosphamide/azathioprine or rituximab；
. 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;
. alveolar hemorrhage requiring pulmonary ventilation support；
. History of any malignancy of any organ system within 5 years prior to the first dose, except for basal cell carcinoma of the skin or carcinoma in situ (e.g., cervical or breast carcinoma in situ) that has been completely resected and shows no evidence of local recurrence or metastasis.
. 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；

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Week 24

Trial details

NCT IDNCT07168161

SponsorStaidson (Beijing) Biopharmaceuticals Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-16

Contact for this trial

Aiping Sun

+86 010-67519614 sunaiping@staidson.com

View on ClinicalTrials.gov More ANCA Associated Vasculitis (AAV) trials