ANCA İlişkili Vaskülitte BDB-001 Faz III Çalışması

Sade dilde özet

Bu çalışma, ANCA ilişkili vaskülit (ANCA-associated vasculitis; damar iltihabıyla seyreden bir otoimmün hastalık) olan hastalarda BDB-001 enjeksiyonunu, standart tedavilerle (kortikosteroid ve immünosupresan ilaçlar) birlikte değerlendiriyor. Çalışmaya, granülomatöz polianjiit (GPA) veya mikroskopik polianjiit (MPA) tanılı, 18-75 yaş arası hastalar katılabiliyor. Çalışma Faz 3 aşamasında yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Katılımcı alıyor

Sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Müdahale

BDB-001 injection, Cyclophosphamide, Rituximab, Azathioprine, Prednisone

Başlangıç

10.11.2025

Tahmini bitiş

29.02.2028

Ülkeler

China

İlgili genler

Merkezler

• Beijing, China
• Beijing, China
• Beijing, China
• Beijing, China
• Beijing, China
• Beijing, China
• Chongqing, China
• Chongqing, China
• Xiamen, China
• Lanzhou, China
• Guangzhou, China
• Guangzhou, China
• Meizhou, China
• Shaoguan, China
• Shenzhen, China
• Shenzhen, China
• Liuzhou, China
• Nanning, China
• Nanning, China
• Guiyang, China
• Cangzhou, China
• Shijiazhuang, China
• Tangshan, China
• Harbin, China
• Luoyang, China
• Zhengzhou, China
• Wuhan, China
• Yichang, China
• Changde, China
• Changsha, China
• Changsha, China
• Changsha, China
• Huaihua, China
• Zhuzhou, China
• Nanjing, China
• Nanjing, China
• Xuzhou, China
• Nanchang, China
• Nanchang, China
• Changchun, China

+20

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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