NCT05828953

Anlotinib Capsules in the Treatment for IPF/PF-ILDs

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Anlotinib Capsules for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)/Progressive Fibrosis-interstitial Lung Disease (PF-ILDs)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The use of Anlotinib hydrochloride capsules for the treatment of IPF/PF-ILDs, with FVC as the primary efficacy endpoint to evaluate its effectivenes

Detailed description

Drug: Anlotinib The dose of nintedanib 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 dose is due within 12 hours, it should not be made up. Drug: Placebo Placebo, taken orally once daily before breakfast. 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 dose is due within 12 hours, it should not be made up. 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.The change in FVC from baseline at week 52 after administration.

Conditions

• Interstitial Lung Diseases

Interventions

Type	Name	Description
DRUG	Anlotinib	Drug: Anlotinib The dose of nintedanib 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 dose is due within 12 hours, it should not be made up.
DRUG	Placebo	Placebo, taken orally once daily before breakfast. 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 dose is due within 12 hours, it should not be made up.

Timeline

• Start date: 2021-09-28
• Primary completion: 2026-03-04
• Completion: 2026-09-09
• First posted: 2023-04-25
• Last updated: 2026-02-17

Locations

1 site across 1 country: China