A Randomized, Double-Blind, Head-to-Head Phase 3 Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone at 52 Weeks in Adults With Idiopathic Pulmonary Fibrosis (SURPASS-IPF)
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- PureTech
- 入组人数
- 1,100
- 主要终点
- Absolute change in forced vital capacity (FVC) measured in mL
概览
简要总结
This is a study for adults with a lung disease called idiopathic pulmonary fibrosis. The main purpose of this study is to look at how well deupirfenidone improves lung function and how safe it is for people with idiopathic pulmonary fibrosis (IPF) when compared with pirfenidone. Participants may have been treated with an approved antifibrotic drug for up to a year in the past, but they cannot be on background antifibrotic treatment during this study. Participants will be randomly assigned (meaning by chance) to take either deupirfenidone or pirfenidone 3 times a day, and neither a participant nor their study team will know which study drug participants are on. Participants will be in the study for up to approximately 3 years. During the first year, participants visit the study site up to ten times and afterwards they visit the site every three months. All participants will remain on blinded study drug until the last participant has completed Week 52 Visit. They will have lung function tests, a check of their health, and will tell the study team about any unfavorable effects.
详细描述
This is a Phase 3 randomized, double-blind, head-to-head study comparing deupirfenidone 825 mg TID to pirfenidone 801 mg TID over 52 weeks of treatment in participants with IPF who are not on background therapy. This study is designed to demonstrate superior efficacy of deupirfenidone over pirfenidone as well as support the overall safety profile of deupirfenidone. Prospective participants will initially enter the Screening Period to determine study eligibility (Section 5). Eligible participants will be randomized 1:1 to receive either blinded deupirfenidone 825 mg TID or pirfenidone 801 mg TID as part of the Double-Blind Treatment Period for at least 52 weeks (Period 1). Depending on when participants enter the study, they may continue being treated for up to two more years (Period 2).
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)
盲法说明
Study drugs are over-encapsulated
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
- •Is ≥40 years of age at the time of informed consent.
- •Meets the diagnostic criteria of IPF American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) 2022 guidelines.
- •Has a maximum time from initial IPF diagnosis of 7 years.
- •Has no prior exposure to pirfenidone or LYT-100, and has \<12 months of prior exposure to nintedanib or any other approved antifibrotic therapies.
- •Has definite or probable unusual interstitial pneumonia (UIP) on HRCT, performed within 12 months prior to Visit 1 and confirmed by the central reader.
- •Has an FVC ≥45% of predicted normal at Visit 1.
排除标准
- •Has, in the opinion of the Investigator, significant clinical worsening of IPF between Visit 1 and Visit
- •Has been hospitalized within 3 months prior to Visit 1 for acute exacerbation of IPF or other significant respiratory complication.
- •Has prebronchodilator forced expiratory volume in 1 second (FEV1)/FVC \<0.7 at Visit
- •Has a greater extent of emphysema vs fibrosis on the most recent HRCT scan as confirmed by the central reader.
- •Has a diagnosis of any condition that could be an explanation for interstitial lung disease (ILD).
- •Has a major extrapulmonary condition that could affect spirometry.
- •Has a current diagnosis of other relevant respiratory disorders.
- •Has significant pulmonary hypertension (PH).
- •Has had a lung transplant.
- •Has cardiovascular disease.
研究组 & 干预措施
Active
deupirfenidone 825 mg TID
干预措施: Deupirfenidone (Drug)
Active Comparator
pirfenidone 801 mg TID
干预措施: Pirfenidone (PFD) (Drug)
结局指标
主要结局
Absolute change in forced vital capacity (FVC) measured in mL
时间窗: Baseline to Week 52
Evaluate the efficacy of deupirfenidone compared with pirfenidone on reduction in lung function decline in participants with IPF
次要结局
- Absolute change in FVC percent predicted (FVCpp)(Baseline to Week 52)