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New treatment option for ANCA Associated Vasculitis (AAV)
Official title BDB-001 Phase III Trial in ANCA-Associated Vasculitis
ClinicalTrials.gov ID: NCT07168161
What this study is testing
What is BDB-001 injection?
BDB-001 injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anca associated vasculitis (aav).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)；
- Estimated glomerular filtration rate ≥15 mL/minute/1.73 m\^2；
You likely can't join if
- 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...
- Any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus...
- HBsAg positive,or HBcAb positive and HBV-DNA positive；
- Received CYC within 3 months before the first administration or Received rituximab(RTX) or other B-cell antibody within 12 months before the first...
See the full eligibility 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；
- 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...
- Any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus, IgA vasculitis (Henoch-Schönlein), rheumatoid...
- HBsAg positive,or HBcAb positive and HBV-DNA positive；
- Received CYC within 3 months before the first administration or Received rituximab(RTX) or other B-cell antibody within 12 months before the first administration；
- Received glucocorticoid shock therapy within 4 weeks before the first administration；
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Xiamen, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Meizhou, Guangdong, China
- Shaoguan, Guangdong, China
- Shenzhen, Guangdong, China
- Liuzhou, Guangxi, China
- Nanning, Guangxi, China
- Nanning, Guangxi Zhuang Autonomous Region (gzar), China
- Guiyang, Guizhou, China
- Cangzhou, Hebei, China
- Shijiazhuang, Hebei, China
- Tangshan, Hebei, China
- Harbin, Heilongjiang, China
- Luoyang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Yichang, Hubei, China
+ 22 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Xiamen, Fujian, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Meizhou, Guangdong, China and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.