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

An Open-label Extension Trial of the Long-term Safety and Efficacy of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07019090

Acronym

IPF

Enrollment

120

Registered

2025-06-13

Start date

2025-06-27

Completion date

2027-01-19

Last updated

2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

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.

Interventions

DRUGHSK44459

HSK44459

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Contacts

Primary ContactCao yong

caoyong@haisco.com18036618841

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026