Anti-nötrofil Sitoplazmik Antikor (ANCA) İlişkili Vaskülitli Hastalarda Glukokortikoid Yerine BDB-001 Enjeksiyonunun Etkililiği ve Güvenliliği

Sade dilde özet

Bu çalışma, ANCA ilişkili vaskülit (ANCA-associated vasculitis; damar iltihabı hastalığı) olan hastalarda, standart glukokortikoid tedavisinin yerine BDB-001 enjeksiyonunun kullanılmasının etkililiğini ve güvenliliğini değerlendirmiştir. Çalışmaya, 18-75 yaş arasında, granülomatöz polianjiit (GPA) veya mikroskopik polianjiit (MPA) tanısı olan ve siklofosfamid ile tedavi gerektiren hastalar alınmıştır. Çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

PHASE1/PHASE2

Durum

Tamamlandı

Sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Müdahale

BDB-001 injection, Cyclophosphamide, Glucocorticoids

Başlangıç

22.02.2022

Tahmini bitiş

19.03.2025

Ülkeler

China

İlgili genler

Merkezler

• Hefei, China
• Beijing, China
• Beijing, China
• Beijing, China
• Nanning, China
• Shijiazhuang, China
• Shijiazhuang, China
• Luoyang, China
• Zhengzhou, China
• Wuhan, China
• Changsha, China
• Changsha, China
• Changsha, China
• Nanchang, China
• Shengyang, China
• Shenyang, China
• Yinchuan, China
• Shanghai, China
• Xi’an, China
• Xi’an, China
• Tianjin, China
• Hangzhou, China

Uygunluk kriterleri

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

Inclusion 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 cyclophosphamide(CYC) and glucocorticoids(GCs)；
* 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；

Exclusion Criteria:

* Active tuberculosis infection;
* Severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage requiring pulmonary ventilation support, rapid-onset mononeuritis multiplex or central nervous system involvement；
* 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；
* HBsAg positive,or HBcAb positive and HBV-DNA positive；
* Received CYC within 3 months before the first administration or Received rituximab(RTX) 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.