NCT07363265尚未招募2 期
A Multicenter, Open-label Phase Ⅱ Study to Evaluate the Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease
Longbio Pharma1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2026年2月2日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change from baseline in 24-hour urinary protein-to-creatinine ratio (UPCR) in Basket 1 cohort
研究概览
简要总结
This is a multicenter, open-label, proof-of-concept, phase Ⅱ adaptive basket clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic profile of LP-005 Injection as add-on therapy to standard treatment in patients with complement-mediated renal diseases.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 to 65 years at screening.
- •Body weight of ≥ 40 kg and a body mass index (BMI) within the range of 15 to 35 kg/m^2 (inclusive).
- •Patients with complement-mediated renal disease.
- •Females and males of childbearing potential (including the participants' partners) must agree to use effective contraceptive measures during the trial and for 3 months after the trial ends.
- •Willing to participate in this clinical trial and voluntarily sign the informed consent form; additionally, be assessed by the investigator as being able to fully understand and comply with all planned study procedures and other requirements.
排除标准
- •Pregnant or lactating female.
- •History of meningococcal infection.
- •Active, uncontrolled acute, chronic, or recurrent infection within 4 weeks prior to screening.
- •Other severe, poorly controlled comorbidities within 3 months prior to screening.
- •Patients with known hypersensitivity to any component of LP-005 or a history of atopic diathesis.
- •History of malignancy within 5 years prior to screening, except for resected cutaneous basal cell carcinoma, resected cutaneous squamous cell carcinoma, and completely resected carcinoma in situ without evidence of local recurrence or metastasis (e.g., cervical carcinoma in situ or breast carcinoma in situ).
- •Prior use of any complement inhibitor within 3 months prior to screening or 5 half-lives of the drug, whichever is longer.
- •Participation in another clinical trial with administration of investigational drug or medical device within 4 weeks prior to screening or 5 half-lives of the administered product, whichever applies.
- •Any condition that, in the investigator's judgment, may impede study participation, pose a safety risk to the participant, or confound the interpretation of study results.
研究组 & 干预措施
LP-005
Experimental
Patients with complement-mediated renal diseases will be treated with predefined dose of LP-005 (1200 mg or 1500 mg).
干预措施: LP-005 Injection (Biological)
结局指标
主要结局
Change from baseline in 24-hour urinary protein-to-creatinine ratio (UPCR) in Basket 1 cohort
时间窗: Week 24
Proportion of patients with a ≥25% reduction in serum creatinine (SCr) from baseline in Basket 2 cohort
时间窗: Week 24
Proportion of patients without dialysis requirement in Basket 3 cohort
时间窗: Week 24
次要结局
- Change from baseline in serum creatinine (SCr)(Up to approximately 64 weeks)
- Change from baseline in estimated glomerular filtration rate (eGFR)(Up to approximately 64 weeks)
- Incidence of AEs(Up to approximately 64 weeks)
- Serum concentrations of LP-005(Up to approximately 64 weeks)
- Number of patients with anti-drug antibodies (ADA)(Up to approximately 64 weeks)
研究者
研究点 (1)
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