BDB-001 Phase III Trial in ANCA-Associated Vasculitis

Not Applicable

Not yet recruiting

• Conditions: ANCA Associated Vasculitis (AAV)
• Interventions: Drug: BDB-001 injection; Drug: Cyclophosphamide; Biological: Rituximab; Drug: Azathioprine; Drug: Prednisone

• Registration Number: NCT07168161
• Lead Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-09-04
• Study First Submitted QC: 2025-09-04
• Study First Posted: 2025-09-11
• Study Start: 2025-09-29
• Last Update Submitted: 2025-09-29
• Last Update Posted: 2025-09-30
• Primary Completion: 2027-04-16
• Study Completion: 2028-02-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. 18 years old≤Age≤75 years old, male or female;
2. Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA)；
3. Newly diagnosed or relapsed GPA or MPA that requires treatment with a full starting dose of prednisone plus cyclophosphamide/azathioprine or rituximab；
4. Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)；
5. Estimated glomerular filtration rate ≥15 mL/minute/1.73 m^2；
6. At least 1 major item, or at least 3 non-major items, or at least the 2 renal items on BVAS；

Exclusion Criteria

1. Active tuberculosis infection;
2. alveolar hemorrhage requiring pulmonary ventilation support；
3. 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；
4. HBsAg positive,or HBcAb positive and HBV-DNA positive；
5. Received CYC within 3 months before the first administration or Received rituximab(RTX) within 12 months before the first administration；
6. Received glucocorticoid shock therapy within 4 weeks before the first administration；
7. Received an oral daily dose of a GC of > 10 mg prednisone-equivalent for more than 6 weeks continuously before the first administration；
8. Received a anti-tumor necrosis factor and other biological agents treatment within 12 weeks before the first administration；
9. Received Continuous dialysis treatment for 12 weeks or more before the first administration; Received Dialysis within 1 week before the first administration;
10. Received intravenous immunoglobulin (Ig) or plasma exchange within 4 weeks before the first administration;
11. Pregnant or lactating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BDB-001 injection group	BDB-001 injection	BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
BDB-001 injection group	Cyclophosphamide	BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
BDB-001 injection group	Rituximab	BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
BDB-001 injection group	Azathioprine	BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
Prednisone group	Cyclophosphamide	BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.
Prednisone group	Rituximab	BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.
Prednisone group	Azathioprine	BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.
Prednisone group	Prednisone	BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.

Primary Outcome Measures

Name	Time	Method
The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS)	Week 24

Secondary Outcome Measures

Name	Time	Method
Cumulative dose of glucocorticoids	Week 24 and 48
The proportion of patients achieving disease sustained remission assessed by Birmingham Vasculitis Activity Score (BVAS)	Week 48
Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission in the Study	Week 48
Percentage of Participants With BVAS of 0 at Week 4	Week 4
In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Estimated glomerular filtration rate (eGFR)	Baseline, Week 24 and Week 48
In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Urinary albumin:creatinine ratio (UACR)	Baseline, Week 4, 24 and 48
Glucocorticoid-induced Toxicity as Measured by Change From Baseline in the GTI	Baseline, Week 24 and 48
Change from baseline in the Vasculitis Damage Index (VDI)	Baseline, Week 24 and 48
Change From Baseline in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36	Baseline, Week 24 and 48

Trial Locations

Locations (49)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing Municipality, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing Municipality, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing Municipality, China

Peking University International Hospital; 🇨🇳 Beijing, Beijing Municipality, China

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing Municipality, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

The First Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Sun Yat-sen Memorial Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

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