NCT07796256尚未招募2 期
A Multicenter, Randomized, Open-Label Phase II Study to Evaluate the Efficacy and Safety of Multiple Doses of SGB-9768 in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Suzhou Sanegene Bio Inc.2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年10月31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
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Mean LDH change from baseline
研究概览
简要总结
This is a multicenter, randomized, open-Label Phase II study to evaluate the efficacy and safety of multiple doses of SGB-9768 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants ≥ 18 years of age;
- •Diagnosis of PNH confirmed by flow cytometry, with a PNH clone size >10% in granulocytes and/or monocytes;
- •Mean hemoglobin level <100 g/L at screening.
- •Lactate Dehydrogenase (LDH) > 1.5 x Upper Limit of Normal (ULN) at screening.
- •Complement inhibitor-naïve, or previous complement inhibitor therapy discontinued for more than 5 drug half-lives or 3 months before randomization.
- •Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given.
排除标准
- •Patients with reticulocytes <100x10⁹/L; platelets <30x10⁹/L; neutrophils <0.5x10⁹/L.
- •History of congenital asplenia or splenectomy.
- •Known or suspected hereditary or acquired complement deficiencies/abnormalities.
- •Active or recurrent invasive infections caused by encapsulated bacteria (e.g., Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae).
- •Active systemic bacterial, viral, or fungal infection within 14 days before randomization.
- •Evidence or history of tuberculosis infection (except adequately treated inactive tuberculosis with negative screening results).
- •Recurrent chronic infections within 1 year before screening.
- •Positive virology tests indicating active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), or syphilis infection.
研究组 & 干预措施
Arm 3
Experimental
Participants will receive multiple doses of SGB-9768.
干预措施: SGB-9768 (Drug)
Arm 2
Experimental
Participants will receive multiple doses of SGB-9768.
干预措施: SGB-9768 (Drug)
Arm 1
Experimental
Participants will receive multiple doses of SGB-9768.
干预措施: SGB-9768 (Drug)
结局指标
主要结局
Mean LDH change from baseline
时间窗: weeks 18-24
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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