A Randomized, Controlled Study to Evaluate LNP023 (Iptacopan) in Patients With Active ANCA-associated Vasculitis
概览
- 阶段
- 2 期
- 干预措施
- Placebo
- 疾病 / 适应症
- Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis
- 发起方
- Novartis Pharmaceuticals
- 入组人数
- 84
- 试验地点
- 58
- 主要终点
- Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48.
- 状态
- 进行中（未招募）
- 最后更新
- 8天前
概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), when used in combination with rituximab (RTX) induction. The trial will also assess the impact of iptacopan on disease relapses, evolution of renal function and proteinuria, GC side effects, patients' immune status, and QoL.
详细描述
This is a randomized, controlled study to evaluate the efficacy and safety of iptacopan in combination with RTX induction therapy for the treatment of newly diagnosed or relapsed patients with active GPA or MPA.
研究者
入排标准
入选标准
- •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.
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 (eGFR) \<15 mL/minute/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.
研究组 & 干预措施
Control
Matching placebo
干预措施: Placebo
Control
Matching placebo
干预措施: Rituximab
Iptacopan
LNP023 administered orally
干预措施: Rituximab
Iptacopan
LNP023 administered orally
干预措施: Iptacopan
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.
时间窗: At Week 48
To assess the effect of iptacopan in achieving sustained remission compared to standard of care (SOC)
次要结局
- B cell counts(At Week 48)
- Total IgG levels(At Week 48)
- Complete remission at week 24(At week 24)
- Time to reach BVAS=0(At Week 24)
- Time to major relapse(At Week 48)
- Estimated glomerular filtration rate (eGFR) using the CKD-EPI formula, urinary protein excretion and hematuria over 48 weeks(At Week 48)
- Cumulative dose of glucocorticoid (GC)(At Week 48)