NCT07212426进行中（未招募）2 期
A Phase II, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria.
Longbio Pharma1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月14日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline in serum lactate dehydrogenase (LDH) levels.
研究概览
简要总结
This is a multicenter, randomized, open-label, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetics of LP-005 injection 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 65 years.
- •Diagnosis of PNH based on flow cytometry with clone size > 10% by granulocytes.
- •Presence of one or more PNH-related signs or symptoms within 3 months prior to screening or a history of transfusion due to PNH.
- •LDH level ≥2.0×upper limit of the normal range(ULN).
- •Hemoglobin level <100 g/L at screening.
排除标准
- •Active or suspected active viral, bacterial, fungal, or parasitic infection within 14 days prior to screening.
- •History of meningococcal infection.
- •History of splenectomy or congenital asplenia.
- •History of systemic autoimmune disease or known/suspected immunodeficiency.
- •History of hematopoietic stem cell transplantation.
- •Use of any complement inhibitor within 3 months prior to screening or within 5 drug half-lives (whichever is longer).
- •Pregnant or breastfeeding women, or women planning to become pregnant during the study or follow-up period.
研究组 & 干预措施
LP-005 900 mg
Experimental
Patients will receive intravenous infusion of LP-005 Injection at a dose of 900 mg once every 4 weeks.
干预措施: LP-005 Injection (Biological)
LP-005 1200 mg
Experimental
Patients will receive intravenous infusion of LP-005 Injection at a dose of 1200 mg once every 4 weeks.
干预措施: LP-005 Injection (Biological)
LP-005 1500 mg
Experimental
Patients will receive intravenous infusion of LP-005 Injection at a dose of 1500 mg once every 4 weeks.
干预措施: LP-005 Injection (Biological)
结局指标
主要结局
Change from Baseline in serum lactate dehydrogenase (LDH) levels.
时间窗: Baseline and at Week 12.
Proportion of participants with ≥2 g/dL increase in hemoglobin level from Baseline in the absence of transfusion.
时间窗: Baseline and at Week 24.
次要结局
- Changes in serum complement hemolytic activity.(Observation from Predose on Day 1 through 337 days post-administration.)
- Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs).(Baseline up to approximately 13 months.)
- Serum concentrations of LP-005.(Observation from Predose on Day 1 through 337 days post-administration.)
- Number of Participants with Treatment-emergent Anti-Drug Antibodies (ADA) and neutralizing antibodies (Nab) Response to LP-005.(Observation from Predose on Day 1 through 337 days post-administration.)
- Proportion of participants with ≥2 g/dL increase in hemoglobin level from Baseline in the absence of transfusion.(Baseline and at Week 12 and 48)
- Proportion of participants who are transfusion-free.(Baseline to Week 12, 24 and 48)
- Change from Baseline in the number of red blood cell (RBC) transfusions.(Baseline to Week 24 and 48.)
- Change from Baseline in hemoglobin levels.(Baseline, Week 12, 24 and 48)
- Proportion of participants achieving hemoglobin levels ≥100 g/L in the absence of transfusion.(Baseline, Week 12, 24 and 48)
- Proportion of participants with LDH levels normalized.(Baseline, Week 12, 24 and 48)
- Change From Baseline in Fatigue as Measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)(Baseline and at Week 12, 36, and 48.)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Study of YM155 plus docetaxel as the first treatment option for patients with Her2 negative metastatic breast cancerEUCTR2009-012439-14-CZAstellas Pharma Global Development, Inc. (APGD)100
进行中（未招募）
1 期
Study of YM155 plus docetaxel as the first treatment option for patients with Her2 negative metastatic breast cancerAdenocarcinoma of the breast that is HER2 negative.MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-012439-14-BEAstellas Pharma Global Development, Inc. (APGD)100
进行中（未招募）
不适用
Study of YM155 plus docetaxel as the first treatment option for patients with Her2 negative metastatic breast cancerEUCTR2009-012439-14-DEAstellas Pharma Global Development, Inc. (APGD)100
进行中（未招募）
不适用
Study of YM155 plus docetaxel as the first treatment option for patients with Her2 negative metastatic breast cancerEUCTR2009-012439-14-IEAstellas Pharma Global Development, Inc. (APGD)100
进行中（未招募）
1 期
Study of YM155 plus docetaxel as the first treatment option for patients with Her2 negative metastatic breast cancerEUCTR2009-012439-14-GBAstellas Pharma Global Development, Inc. (APGD)100