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
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
Treatments tested in this trial
- BDB-001 injection
- Cyclophosphamide
- Rituximab
- Azathioprine
- Prednisone
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov