NL-OMON55928招募中2 期
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis - CADPT09A12201
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Male and female participants at least 40 years of age
- •-IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guidelines
- •-FVC >=45% predicted
- •-DLCO, corrected for hemoglobin, >=25% predicted (inclusive)
- •-Unlikely to undergo lung transplantation during this trial in the opinion of
- •the investigator
- •-If a participant is taking nintedanib or pirfenidone, they must be on a stable
- •regimen for at least 8 weeks prior to randomization
- •Additional protocol-defined inclusion criteria may apply.
排除标准
- •-Airway obstruction (i.e. prebronchodilator FEV1/ FVC < 0.7) or evidence of a bronchodilator response at screening -Emphysema >20% on screening HRCT -Fibrosis <10% on screening HRCT -Clinical diagnosis of any connective tissue disease -Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization Additional protocol-defined exclusion criteria may apply.
研究者
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