NCT05389215进行中（未招募）2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis
Daewoong Pharmaceutical Co. LTD.59 个研究点 分布在 3 个国家目标入组 102 人开始时间: 2022年7月29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
- 进行中（未招募）
- 发起方
- 入组人数
- 102
- 试验地点
- 59
- 主要终点
- Rate of decline of FVC
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
详细描述
This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥40 years based on the date of the written informed consent form
- •Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
- •In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
- •Patients receiving local standard-of-care for IPF, defined as either pirfenidone or nintedanib, at a stable dose for at least 3 months prior to screening, or neither pirfenidone nor nintedanib. If the patients were on pirfenidone or nintedanib previously and have been off for at least 3 months prior to screening, they will be considered as not on any treatment for IPF
- •Meeting all of the following criteria during the screening period:
- •FVC ≥40% predicted of normal
- •DLCO corrected for Hgb ≥25% and ≤80% predicted of normal.
- •forced expiratory volume in the first second/FVC (FEV1/FVC) ratio ≥0.7 based on pre-bronchodilator value
排除标准
- •Acute IPF exacerbation within 6 months prior to screening and/or during the screening period
- •Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
- •Female patients who are pregnant or nursing
- •Abnormal ECG findings
- •Use of any investigational drugs for IPF within 4 weeks prior to screening
研究组 & 干预措施
DWN12088 Xmg Tablet (BID)
Experimental
PRS inhibitor
干预措施: DWN12088 (Drug)
Placebo 0mg Tablet (BID)
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of decline of FVC
时间窗: From Day 1 through Week 24
To investigate the efficacy of DWN12088 on pulmonary function
Incidents of treatment-emergent adverse events
时间窗: From Day 1 through Week 24
To evaluate the safety and tolerability of DWN12088 compared with placebo
次要结局
- Time to progression of IPF(From Day 1 through Week 24)
- Quantitative high-resolution computed tomography(From Day 1 through Week 24)
- Functional exercise capacity, assessed by the 6-minute walk test (6MWT) distance(From Day 1 through Week 24)
- Diffusing capacity of lung for carbon monoxide (DLCO) corrected for Hgb(From Day 1 through Week 24)
研究者
研究点 (59)
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