A Phase II, Multi-center, Randomized, Double-blinded, Placebo-controlled Clinical Study Evaluating the Efficacy and Safety of TDI01 Suspension for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Change From Baseline in Forced Vital Capacity (FVC) (mL) at Week 24
研究概览
简要总结
This trial was performed in patients with idiopathic pulmonary fibrosis (IPF) to evaluate the clinical efficacy and safety of different doses of TDI01 Suspension, compared with control, for the treatment of patients with IPF.
详细描述
This is a Phase II, multi-center, randomized, double-blinded, placebo-controlled clinical study to evaluate the efficacy and safety of TDI01 Suspension for the treatment of IPF. The study consists of a 4-week screening period, a 24-week treatment period, a 28-week extension period, and a 2-week safety follow-up period.
It is planned to include 120 IPF patients. All subjects will be randomized in a 1:1:1 ratio to receive a 24-week treatment with TDI01 Suspension dosage A, TDI01 Suspension dosage B, or the placebo. At Week 24, the subjects will be evaluated for the primary efficacy endpoints and subsequently enter the extension period. Subjects may continue receiving the investigational product until Week 52 at their voluntary consent.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental group 1
TDI01 dose A, once daily
干预措施: TDI01 suspension (Drug)
Experimental group 2
TDI01 dose B, once daily
干预措施: TDI01 suspension (Drug)
Control group
Placebo, once daily
干预措施: TDI01 suspension (Drug)
结局指标
主要结局
Change From Baseline in Forced Vital Capacity (FVC) (mL) at Week 24
时间窗: At 24 week
The mean change in FVC (ml) from baseline at week 24, measured by spirometer
次要结局
- Change From Baseline in FVC% Predicted(From baseline up to week 52)
- Change From Baseline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) %(From baseline up to week 24)
- Mean Change in Distance Walked in the 6-minute Walk Test (6MWT)(From baseline up to week 24)
- Proportion of Subjects with an Absolute Decrease of FVC% Predicted Greater than 10%(From baseline up to week 52)
- Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation(From baseline up to week 52)
- Time to Disease Progression(From baseline up to week 52)
- The change in St.George's respiratory questionnaire（SGRQ）(From baseline up to week 24)