NCT05975983招募中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
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 12
- 主要终点
- Percentage of subjects who have at least 1 treatment-emergent adverse event (TEAE)
研究概览
简要总结
The purpose of this revised Phase IIa study is to demonstrate safety of INS018_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).
详细描述
Idiopathic pulmonary fibrosis is a fatal lung disease characterized by reduced quality of life (QoL) and a median survival of 3 to 4 years. While current standard of care (SoC) treatments including pirfenidone and nintedanib slow disease progression, they are not curative and poorly tolerated due to their toxicity profiles. To address the need for new treatments in IPF, InSilico Medicine is developing INS018_055, a potent inhibitor of the serine/threonine kinase Traf2- and Nckinteracting kinase (TNIK).
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
- •Meeting all of the following criteria during the screening period:
- •FVC ≥40% predicted normal
- •DLCO corrected for Hgb ≥25% and <80% predicted 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 Day 1, 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
研究组 & 干预措施
INS018_055
Experimental
INS018_055 is administered once daily up to 12 weeks
干预措施: INS018_055 (Drug)
Placebo
Placebo Comparator
Placebo is administered once daily up to 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects who have at least 1 treatment-emergent adverse event (TEAE)
时间窗: Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))
次要结局
- Time to reach maximum plasma concentration (Tmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095)(Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)))
- Maximum plasma concentration (Cmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095)(Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)))
- Area under the plasma concentration-time curve from time zero to dosing interval τ (AUC0-τ) of INS018_055 and its major metabolites (INS018_063 and INS018_095)(Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)))
- Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of INS018_055 and its major metabolites (INS018_063 and INS018_095)(Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)))
- Area under the plasma concentration-time curve from time zero to infinity (∞) (AUC0-∞) of INS018_055 and its major metabolites (INS018_063 and INS018_095)(Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)))
- Terminal elimination half-life (t1/2) of INS018_055 and its major metabolites (INS018_063 and INS018_095)(Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)))
- Terminal elimination rate constant (λz) of INS018_055 and its major metabolites (INS018_063 and INS018_095)(Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)))
- Apparent clearance (CL/F) of INS018_055 and its major metabolites (INS018_063 and INS018_095)(Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)))
- Apparent volume of distribution (Vz/F) of INS018_055 and its major metabolites (INS018_063 and INS018_095)(Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)))
- Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and its major metabolites (INS018_063 and INS018_095)(Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)))
- Trough plasma concentration (Ctrough) of INS018_055 and its major metabolites (INS018_063 and INS018_095)(Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)))
- Relative change in Forced Vital Capacity (FVC) in mL(Week 0/Visit 2 up to Week 12)
- Percentage change in FVC in mL(Week 0/Visit 2 up to Week 12)
- Absolute and relative change in FVC % predicted(Week 0/Visit 2 up to Week 12)
- Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted(Week 0/Visit 2 to Week 12)
- Change in Leicester Cough Questionnaire (LCQ)(Week 0 to Week 4, 8 and 12)
- Change in 6-Minute Walk Distance (6MWD) in meters(Week 0 to Week 12)
- Number of acute IPF exacerbations(Week 0 up to Week 12)
- Number of days hospitalized for acute IPF exacerbations(Week 0 to up Week 12)
研究者
研究点 (12)
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相关资讯
Insilico Medicine's AI-Driven IPF Candidate Shows Promise in Phase IIa Trial, Plans Pivotal Study• Insilico Medicine's ISM001-055 demonstrated improved forced vital capacity (FVC) in IPF patients after 12 weeks in a Phase IIa trial.
• The drug showed a dose-dependent improvement in lung function, with the highest dose (60 mg QD) resulting in a 98.4 mL mean FVC improvement from baseline.
• Insilico plans to initiate discussions with regulatory bodies to pursue a potentially pivotal global Phase IIb trial enrolling approximately 270 patients.
• A U.S. Phase IIa trial of ISM001-055 is currently enrolling patients, with potential for accelerated enrollment following positive Phase IIa results in China.last yearInsilico Medicine's AI-Designed Drug Shows Promise in Phase IIa IPF Trial- Insilico Medicine's ISM001-055 met its primary safety endpoint and secondary efficacy endpoints in a Phase IIa trial for idiopathic pulmonary fibrosis (IPF).
- The AI-designed drug demonstrated a dose-dependent improvement in forced vital capacity (FVC), a key measure of lung function, in IPF patients.
- The company plans to engage with regulatory authorities to design a Phase IIb study, exploring extended treatment durations and larger patient cohorts.
- ISM001-055 targets TNIK, offering a novel approach to treating IPF by addressing both fibrosis and inflammation, potentially modifying the disease.last year