Long-term Safety and Efficacy Study of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2

Not yet recruiting

• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Interventions: Drug: HSK44459

• Registration Number: NCT07019090
• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Brief Summary

This study is open to people with idiopathic pulmonary fibrosis (IPF) . They can only take part if they have completed treatment in a previous study with a medicine called HSK44459.

The primary object of this study is to find out how well people with idiopathic pulmonary fibrosis (IPF) tolerate long- term treatment with HSK44459.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Start: 2025-06-27
• Primary Completion: 2026-10-31
• Study Completion: 2027-01-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.IPF patients who completed the last dose treatment of HSK44459 in previous trials without prematurely discontinuing treatment permanently according to protocol , and have been evaluated by the researchers to have greater benefits than risks, and may benefit from continued treatment with HSK44459

Exclusion Criteria

1. Patient will plan to undergo lung transplantation.
2. Patients with a Body Mass index (BMI) <18.5 kg/m² that experienced an unexplained and clinically significant (>10%) weight loss during the previous trials.
3. History of malignancy within 5 years prior to screening.
4. History of depression or anxiety disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HSK44459	HSK44459	-

Primary Outcome Measures

Name	Time	Method
The incidence and severity of adverse events during the study period	Up to 52 weeks