Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis

A Randomised, Double-blind, Placebo-controlled Parallel Group Phase III Clinical Study Evaluating the Efficacy and Safety of HSK44459 Tablets in Subjects With Progressive Pulmonary Fibrosis

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07503587

Acronym

PPF

Enrollment

378

Registered

2026-03-31

Start date

2026-04-05

Completion date

2029-03-01

Last updated

2026-03-31

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

Conditions

Progressive Pulmonary Fibrosis

Brief summary

This study is open to adults with PPF . The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.

Interventions

DRUGHSK44459

HSK44459 taken orally twice daily in the morning and in the evening for 52weeks.

DRUGPlacebo

Placebo matching HSK44459 taken orally twice daily in the morning and in the evening for 52 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Adults aged ≥18 year. 2. Diagnosis of PPF other than IPF prior to screening or during the screening period. 3. Patients must meet either of the following conditions: 1\. not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period, and not planning to start or restart antiibrotic therapy. 2.on stable therapy with nintedanib or pirfenidone for at least 12 weeks prior to screening and during the screening period. 4.Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 5.Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin \[Hb\]) ≥ 25% and \<90% of predicted normal at screening period .

Exclusion criteria

1. Clinically significant airways obstruction (Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) \< 0.7) at screening. 2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities. 3. Acute ILD exacerbation within 3 months prior to screening and/or during the screening period. 4. History of malignancy within 5 years prior to screening. 5. History of vasculitis.

Design outcomes

Primary

Measure	Time frame	Description
The change from baseline in forced vital capacity (FVC) at week 52	day 1 and week 52	FVC is a standard pulmonary function test used to quantify respiratory muscle weakness

Contacts

CONTACTSun luyin

sunluyin@haisco.com028-67258779

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026