NCT07160608招募中2 期
Phase 2, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (I TRANSCEND)
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 78
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of tarperprumig in participants with newly diagnosed or relapsing anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed or relapsing ANCA-associated vasculitis, GPA and MPA subtypes consistent with the 2022 ACR/EULAR classification criteria for GPA and MPA for whom treatment with rituximab or cyclophosphamide is considered.
- •Positive test for antibodies to either PR3-ANCA or MPO-ANCA at Screening or in the past by a quantitative assay (for example, ELISA, bead assay).
- •At least one major item, or at least 3 minor items, or at least 2 renal items in the BVAS.
排除标准
- •Other systemic diseases that, in the judgment of the Investigator, constitute the primary illness, including but not limited to: eosinophilic granulomatosis with polyangiitis (EGPA), systemic lupus erythematosus, IgA nephropathy and/or IgA associated vasculitis with or without Henoch-Schonlein purpura, rheumatoid vasculitis, Sjogren's syndrome, anti-GBM disease, cryoglobulinemic vasculitis, autoimmune hemolytic anemia, or mixed connective tissue disease.
- •Alveolar hemorrhage requiring invasive pulmonary ventilation support at Screening.
- •Any diseases or conditions that, in the judgment of the Investigator, present a substantial clinical risk to participate in this study.
- •For patients with a previous diagnosis of CKD, patients known to have a stable eGFR for greater than 3 months prior to Screening and a decline less than 25% of previous eGFR at Screening will be excluded.
研究组 & 干预措施
Tarperprumig Group 2
Experimental
Participants will be administered tarperprumig dose regimen #1 or dose regimen #2.
干预措施: Tarperprumig (Drug)
Tarperprumig Group 2
Experimental
Participants will be administered tarperprumig dose regimen #1 or dose regimen #2.
干预措施: Placebo (Drug)
Placebo Group 3
Experimental
Participants will be administered placebo.
干预措施: Placebo (Drug)
Tarperprumig Group 1
Experimental
Participants will be administered tarperprumig dose regimen #1 or dose regimen #2.
干预措施: Tarperprumig (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Baseline through Week 70
次要结局
- Number of Participants Achieving Disease Remission at Week 26(Week 26)
- Number of Participants Achieving Sustained Remission at Week 52(Week 52)
- Number of Participants Achieving a Birmingham Vasculitis Activity Score (BVAS) of 0(Baseline through Week 52)
- Number of Participants Experiencing a Relapse After Previously Achieving Disease Remission at Week 26(Week 26 through Week 70)
- Time to First Relapse After Having Achieved Disease Remission at Week 26(Week 26 through Week 70)
- Change from Baseline in Vasculitis Damage Index(Baseline, Weeks 26, and 52)
- Time to First Occurrence of BVAS of 0(Baseline through Week 52)
- Change from Baseline in BVAS(Baseline, Weeks 26, and 52)
- Change from Baseline in Estimated Glomerular Filtration Rate(Baseline, Weeks 26, and 52)
- Change from Baseline in Proteinuria Based on Spot Urine Protein-Creatinine Ratio(Baseline, Weeks 26, and 52)
- Change from Baseline in Proteinuria Based on Spot Urine Albumin-Creatinine Ratio(Baseline, Weeks 26, and 52)
- Change from Baseline in Hematuria(Baseline, Weeks 26, and 52)
研究者
研究点 (78)
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