This is an exploratory Phase 2 study evaluating the use of Anlotinib hydrochloride capsules for the treatment of IPF/PF-ILDs, with forced vital capacity (FVC) as the primary efficacy endpoint.
Drug: Anlotinib The dose of anlotinib hydrochloride is 8 mg per dose, taken orally once daily before breakfast. The treatment schedule is 2 consecutive weeks of dosing followed by a 1-week break. The primary endpoint of this study is the change from baseline in forced vital capacity (FVC) at Week 24. Blinded treatment continues through Week 52 to evaluate longer-term efficacy and safety of anlotinib in the treatment of IPF/PF-ILDs, including the change from baseline in FVC at Week 52 as a secondary/supportive endpoint. After Week 52, all subjects may enter an extension period if they wish. If a dose is missed and the next scheduled dose is due within 12 hours, the missed dose should not be taken. Drug: Placebo Placebo is taken orally once daily before breakfast, following the same schedule: 2 consecutive weeks of dosing followed by a 1-week break. Consistent with the study design, the primary endpoint is the change from baseline in FVC at Week 24. Blinded placebo administration continues through Week 52 to support the evaluation of longer-term efficacy and safety, with the change from baseline in FVC at Week 52 as a secondary/supportive endpoint. After Week 52, all subjects may enter an extension period if they wish. If a dose is missed and the next scheduled dose is due within 12 hours, the missed dose should not be taken. FVC stands for forced vital capacity, which is the maximum amount of air that can be forcefully exhaled after a deep inspiration, performed as quickly and completely as possible. This measure assesses lung function and is the core endpoint for evaluating treatment effects in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Drug: Anlotinib The dose of anlotinib hydrochloride is 8mg per dose, taken orally once daily before breakfast. The drug is taken continuously for 2 weeks, followed by a 1-week break, until 24 weeks as the primary endpoint, to observe the long-term efficacy and safety of anlotinib in the treatment of IPF/PF-ILDs. After 24 weeks, the blinded administration was continued until 52 weeks. After 52 weeks, all subjects could enter the extension period if they wished. If a dose is missed and the next scheduled dose is due within 12 hours, the missed dose should be skipped and not made up.
Matching placebo, taken orally once daily before breakfast, administered on the same 2-weeks-on/1-week-off schedule as the experimental arm. The placebo group serves as the comparator for evaluating the efficacy and safety of anlotinib.
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Change from baseline in forced vital capacity (FVC) at Week 24, measured in mL
FVC stands for forced vital capacity, which is typically the maximum amount of air that can be forcefully exhaled after taking a deep breath as quickly and completely as possible. This measure primarily assesses the ability to exhale as much air as possible in the shortest amount of time, and is used as an indicator of lung function.
Time frame: 24weeks
Change from baseline in FVC at Week 52, measured in mL
FVC stands for forced vital capacity, which is typically the maximum amount of air that can be forcefully exhaled after taking a deep breath as quickly and completely as possible. This measure primarily assesses the ability to exhale as much air as possible in the shortest amount of time, and is used as an indicator of lung function.ients with IPF/PF-ILDs.
Time frame: 52weeks
Change from baseline in FVC % predicted at Weeks 24 and 52
FVC (% predicted) was defined as forced vital capacity as a percentage of the predicted value.
Time frame: 24weeks、52weeks
Change from baseline in FEV1 at Weeks 24 and 52, measured in mL/s
FEV1 (ml/s)was defined as forced expiratory volume in one second.
Time frame: 24weeks、52weeks
Change from baseline in FEV1 %predicted at Weeks 24 and 52
FEV1 (% predicted)was forced expiratory volume in one second as a percentage of the predicted value .
Time frame: 24weeks、52weeks
Change from baseline in TLC at Weeks 24 and 52, measured in mL
TLC(ml) was defined as Total Lung Capacity.
Time frame: 24weeks、52weeks
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Change from baseline in TLC % predicted at Weeks 24 and 52
TLC (% predicted) was defined as total lung capacity as a percentage of the predicted value.
Time frame: 24weeks、52weeks
Change from baseline in DLco%predicted at Weeks 24 and 52
DLco%predicted was diffusing capacity of the lung for carbon monoxide as a percentage of the predicted value.
Time frame: 24weeks、52weeks
Change from baseline in 6-minute walk test at Weeks 24 and 52, measured in meters
6-minute walk test is a commonly used method to evaluate physical function and cardiorespiratory health status. The walk distance, usually measured in feet or meters, is an important indicator of the test. It refers to the total distance covered by the subject within 6 minutes, which can reflect their endurance and exercise capacity.
Time frame: 24weeks、52weeks
Change from baseline in HRCT-based fibrosis score at Weeks 24 and 52, as assessed by a prespecified imaging review method.
Relative change from baseline in HRCT.
Time frame: 24weeks、52weeks