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BDB-001 Phase III Trial in ANCA-Associated Vasculitis

ConditionANCA Associated Vasculitis (AAV)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorStaidson (Beijing) Biopharmaceuticals Co., Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)；

Disqualifiers

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；

Trial design

Design model

Parallel

Treatments tested in this trial

  • BDB-001 injection

    Drug

    Intravenously administered

  • Cyclophosphamide

    Drug

    Intravenously administered

  • Rituximab

    Drug

    Intravenously administered

  • Azathioprine

    Drug

    Intravenously administered

  • Prednisone

    Drug

    Intravenously administered

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: BDB-001 injection groupExperimental treatment 4 interventions
Group B: Prednisone groupActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Week 24

Secondary outcomes

1

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

Time frame
Week 48
2

Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission in the Study

Time frame
Week 48
3

Percentage of Participants With BVAS of 0 at Week 4

Time frame
Week 4
4

In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Estimated glomerular filtration rate (eGFR)

Time frame
Baseline, Week 24 and Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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