NCT07519070

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of HSK44459 tablets in patients with idiopathic pulmonary fibrosis (IPF).

Conditions

• IPF

Interventions

Type	Name	Description
DRUG	HSK44459	HSK44459 Without IPF background therapy
DRUG	HSK44459	HSK44459 With Nintedanib
DRUG	HSK44459	HSK44459 With Pirfenidone
DRUG	Placebo	Placebo Without IPF background therapy
DRUG	Placebo	Placebo With Nintedanib
DRUG	Placebo	Placebo With Pirfenidone

Timeline

• Start date: 2026-04-05
• Primary completion: 2028-04-05
• Completion: 2028-12-30
• First posted: 2026-04-09
• Last updated: 2026-04-09