NCT03538301已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 33
- 主要终点
- Number of Participants Discontinuing Study Treatment Due to TEAEs
研究概览
简要总结
A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.
详细描述
All subjects were treated with ND-L02-s0201 or placebo for 24 weeks (a total of 12 doses). Subject's participation in the study was approximately 40 weeks including a Screening and Baseline period of up to 6 weeks, a treatment period of 24 weeks (including the 2 weeks after the last study treatment), and a follow-up period of 10 weeks after End-of-Treatment (EOT).
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Forced vital capacity (FVC) ≥ 45% of predicted.
- •Diffusion capacity of the lung for carbon monoxide (DLco) corrected for hemoglobin ≥ 30% of predicted value
- •Ratio of forced expiratory volume in 1 second (FEV1) to FVC ≥ 0.70.
排除标准
- •Best, acceptable FVC from separate screening spirometry that differ by ≥ 200 mL.
- •Respiratory exacerbation(s) or hospitalization for IPF exacerbation within 3 months before screening.
- •Anticipated to receive a lung transplant during the subject's participation in the study.
- •Active smoker or smoking cessation within 12 weeks before screening.
- •Malignancy within the last 5 years, with the exception of curable cancer that has received adequate treatment.
- •Evidence of any unstable or untreated, clinically significant disease or condition that, in the opinion of the Investigator, might confound the interpretation of the study or place the subject at increased risk.
- •Treatment with high dose corticosteroids, cytotoxic agents, unapproved IPF targeted therapy, and cytokine modulating agents within 8 weeks or 5 half-lives (whichever is longer) before screening
- •Participation in an investigational study with the last dose of investigational product occurring within 8 weeks or 5 half-lives (whichever is longer) before screening.
- •Pregnant or breastfeeding.
- •Medical history of infection with HIV, hepatitis B, or hepatitis C.
- •History of alcohol abuse and/or dependence within the last 2 years.
- •History within the last 2 years of significant mental illness, or physical dependence on any opioid or illicit drugs.
- •Other protocol defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
Dose Level 1
Experimental
ND-L02-s0201 45mg
干预措施: ND-L02-s0201 (Low Dose) (Drug)
Dose Level 2
Experimental
ND-L02-s0201 90mg
干预措施: ND-L02-s0201 (High Dose) (Drug)
结局指标
主要结局
Number of Participants Discontinuing Study Treatment Due to TEAEs
时间窗: Change in the incidence and severity of adverse events related to study treatment from baseline to 24 weeks
The number of participants with TEAEs leading to discontinuation from the study treatment. The Safety Population (including all participants who received at least one dose of study treatment) is presented. TEAE = treatment-emergent adverse event
次要结局
- Rate of Decline in FVC From Baseline to Week 24(Baseline to Week 24)
- Events of Deterioration of IPF Resulting in Lung Transplantation or Death and Rate of Deterioration of IPF Resulting in Lung Transplantation(Baseline to 12 weeks after end of study treatment)
- Percent Change in FVC From Baseline to Week 24(Baseline to Week 24)
- Summary of Study Treatment Response of FVC(Baseline to Visit 14 (Day 169))
- Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT(Baseline to Week 24)
- Rate of Decline in ppFVC From Baseline to Week 24(Baseline to Week 24)
- Absolute and Relative Change in FVC (L) From Baseline to Week 24(Baseline to Week 24)
- Absolute and Relative Change in ppFVC (%) From Baseline to Week 24(Baseline to Week 24)
- Events of Hospitalization for Respiratory Ailments or Death(up to 12 weeks after the end of study treatment)
- Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24(Baseline to Week 24)
- Qualitative Changes of Interstitial Lung Abnormalities as Measured by HRCT(Baseline to Visit 14 (Day 169))
- Total Events of Death Due to All Causes(up to 12 weeks after the end of study treatment)
- Percent Change in ppFVC From Baseline to Week 24(Baseline to Week 24)
- Summary of Study Treatment Response of ppFVC(Baseline to Visit 14 (Day 169))
- Events of IPF Exacerbation or Death and Rate of First IPF Exacerbation(Baseline to study completion, up to Day 239)
研究者
研究点 (33)
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