A Randomized, Double-blind, Placebo-controlled Phase II/III Trial Evaluating the Efficacy and Safety of Sufenidone (SC1011) Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
研究概览
简要总结
Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.
详细描述
Randomized, double-blind study comparing Sufenidone (SC1011) and placebo in IPF patients, with interim analysis at 26 weeks to select the optimal dose for a 52-week treatment period followed by 4-week safety monitoring
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and sign written informed consent.
- •The diagnosis time of IPF before enrollment was less than 5 years.
- •Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF.
- •Dlco (corrected for Hb): 30%-90% predicted of normal.
- •FVC>= 50% predicted of normal.
排除标准
- •Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 after administration of bronchodilator at Screening
- •Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization.
- •Known explanation for interstitial lung disease
- •History of asthma or chronic obstructive pulmonary disease
- •Active infection
- •Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
- •History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
研究组 & 干预措施
Placebo Comparator
Idiopathic pulmonary fibrosis (IPF) patients were administered placebo matching SC1011 taken orally as tablets (matching the respective SC1011 tablets) twice daily, in the morning and in the evening for 52 weeks.
干预措施: Placebo comparator (Drug)
SC1011 200mg
Idiopathic pulmonary fibrosis (IPF) patients were administered SC1011 taken orally as tablets twice daily(200mg daily), in the morning and in the evening for 52 weeks.
干预措施: SC1011 (Drug)
结局指标
主要结局
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
时间窗: Primary Outcome measures will be assessed at baseline and again at 52 weeks.
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.
次要结局
- Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks(Baseline and 52 weeks)
- Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation.(Secondary outcome measures will be assessed at baseline and again at 52 weeks.)