NCT05938920已完成2 期
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 22
- 主要终点
- Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic Pulmonary Fibrosis (IPF).
The primary objective is to evaluate the safety and tolerability of INS018_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.
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
- Double (Participant, Investigator)
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
- •Subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for > 8 weeks prior to Visit 1
- •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 4 months prior to Visit 1 and/or during the screening period, as determined by the investigator
- •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
- •Other protocol inclusion and exclusion criteria may apply.
研究组 & 干预措施
INS018_055 30 mg QD
Experimental
Group 1: INS018_055 once daily up to 12 weeks, low dose
干预措施: INS018_055 (Drug)
INS018_055 30 mg BID
Experimental
Group 2: INS018_055 twice daily up to 12 weeks, low dose
干预措施: INS018_055 (Drug)
INS018_055 60 mg QD
Experimental
Group 3: INS018_055 once daily up to 12 weeks, high dose
干预措施: INS018_055 (Drug)
Placebo
Placebo Comparator
Group 4: Placebo once or twice daily up to 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)
时间窗: From first dose of study drug until end of study (EOS) visit i.e. up to 13 weeks (+10 days)
TEAEs were either events with start date on or after the start of the Treatment Period and up to 17 days after EOT (end of treatment), or events with start date prior to the start of the Treatment Period whose severity worsened on or after the start of the Treatment Period and up to 17 days after EOT. CTCAE=Common Terminology Criteria for Adverse Events
次要结局
- Relative Change From Baseline in Forced Vital Capacity (FVC)(Week 0/Visit 2 up to Week 12)
- Absolute Change From Baseline in FVC in L(Week 0/Visit 2 up to Week 12)
- Absolute Change in FVC % Predicted(Week 0/Visit 2 up to Week 12)
- Relative Change in FVC % Predicted(Week 0/Visit 2 up to Week 12)
研究者
研究点 (22)
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