MedTrace Logo

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

NCT07519070 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2026-04-09

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-05
Primary Completion
2028-04-05
Completion
2028-12-30

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07519070 on ClinicalTrials.gov