NCT07541287招募中2 期
A Phase 2, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of JADE101 in Participants With Immunoglobulin A Nephropathy (JUNIPER)
Jade Biosciences, Inc.20 个研究点 分布在 5 个国家目标入组 30 人开始时间: 2026年5月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 20
- 主要终点
- Incidence of treatment-emergent adverse events (safety and tolerability)
研究概览
简要总结
This open-label Phase 2 study will characterize the safety and efficacy of JADE101 in participants with IgA nephropathy, and the results will contribute to the overall clinical characterization of JADE101 in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants 18-60 years of age, inclusive, and of local legal consenting age at the time of signing the informed consent
- •eGFR ≥ 30 mL/min/1.73 m2
- •Biopsy-confirmed primary IgAN
- •Receiving stable and maximally tolerated doses of either ACEi or ARB as per standard of care (SoC) and applicable guidelines for at least 12 weeks prior to the initial screening visit, with no intention to alter the dose or discontinue treatment, unless medically necessary
- •UPCR ≥ 0.75 g/g
- •Willing to provide written informed consent
- •Willing and able to comply with scheduled study visits, treatment plans, laboratory tests, and other study procedures
- •Willing and able to comply with contraceptive and lifestyle requirements
排除标准
- •Secondary forms of IgAN
- •Known or suspected coexisting Chronic Kidney Disease (CKD) other than IgAN
- •Known or suspected rapidly progressive glomerulonephritis (RPGN)
- •Evidence of pathological findings in the kidney biopsy in addition to IgAN (eg, minimal change disease, diabetic kidney disease, membranous nephropathy, focal segmental glomerulosclerosis, or lupus nephritis); hypertensive vascular changes are acceptable
- •Known or suspected primary or secondary immunodeficiency disorder
- •Evidence of tuberculosis infection at screening
- •Any chronic infectious disease
- •Any acute infectious disease at time of screening
- •Received bone marrow, hematologic stem cell transplantation, or a solid organ transplant, including kidney
- •Known or suspected alcohol or drug abuse
- •Any clinically significant and/or unstable or uncontrolled medical condition as assessed by the investigator
- •Malignancy within the past 5 years; nonmelanoma skin cancer and curatively treated cervical carcinoma in situ are allowed
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
JADE101
Experimental
Subcutaneous (SC) injection of JADE101
干预措施: JADE101 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (safety and tolerability)
时间窗: Day 1 through 100 weeks
The proportion of participants who experience one or more adverse events that begin or worsen after the first dose of study drug
次要结局
- Effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy(Day 1 through 100 weeks)
研究者
研究点 (20)
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