2023-510525-15-00招募中2 期
A randomized, controlled study to evaluate LNP023 (iptacopan) in patients with active ANCA-associated vasculitis.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 31
- 主要终点
- Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48.
研究概览
简要总结
To assess the effect of iptacopan in achieving sustained remission compared to standard of care (SOC)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent obtained prior to participation in the study.
- •Newly diagnosed or relapsed GPA and MPA (according to the 2022 ACR/EULAR classification criteria for GPA and MPA) requiring treatment with RTX and GC as per investigator's judgement.
- •BVAS assessment with ≥1 major item, or ≥3 minor items, or ≥2 renal items at Screening.
- •Positive antibody test for anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO) antibodies at Screening or with history of documented evidence of a positive antibody test.
- •Male or female subjects ≥18 years at Screening.
排除标准
- •Other systemic disease which constitutes the primary illness, including but not limited to: eosinophilic granulomatosis with polyangiitis (EGPA), moderate to severe systemic lupus erythematosus, IgA vasculitis (Purpura Schönlein-Henoch), rheumatoid vasculitis, Sjögren's syndrome, anti-glomerular basement membrane (GBM) disease, cryoglobulinemic vasculitis, autoimmune hemolytic anemia, autoimmune lymphoproliferative syndrome or mixed connective tissue disease.
- •Alveolar hemorrhage requiring invasive pulmonary ventilation support at Screening.
- •Severe kidney disease defined as estimated glomerular filtration rate <15 mL/min/1.73m2, or kidney failure defined as receiving renal replacement therapy such as hemo(dia)filtration, hemo-/peritoneal dialysis, or having received a kidney transplant.
- •Received plasma exchange/-pheresis within 12 weeks prior to Screening.
- •Received any of the following immunosuppressive, cell depleting or biological therapy (any other immunosuppressive, cell depleting, or biological therapy not listed here must be discussed with the Sponsor): • Received RTX or other B-cell depleting agent within 16 weeks prior to Screening. • Received any of the following biological or alkylating immunosuppressive medications within 12 weeks before screening, including but not limited to: • cyclophosphamide (CYC) • complement inhibitor (such as eculizumab, ravulizumab, avacopan) • anti-tumor necrosis factor • abatacept • tocilizumab • intravenous immunoglobulins • Received any of the following cell depleting agents within 24 weeks before Screening, including but not limited to: • alemtuzumab • antithymocyte globulin • Received azathioprine (AZA), methotrexate (MTX), or mycophenolate (MMF), or any other immunosuppressants with similar half-life within 1 week prior to Day
- •Received leflunomide (LEF) within 6 weeks prior to Day 1.
结局指标
主要结局
Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48.
Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48.
次要结局
- Time to reach BVAS = 0
- Time to major relapse through Week 48
- Estimated glomerular filtration rate (eGFR) using the CKD-EI formula, urinary protein excretion and hematuria over 48 weeks.
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (31)
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