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NCT Number: NCT07503587

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged ≥18 year.
  • Diagnosis of PPF other than IPF prior to screening or during the screening period.
  • Patients must meet either of the following conditions:
  • 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

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

Treatment and study plan

HSK44459

Drug

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

Placebo

Drug

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

Primary outcomes

  1. The change from baseline in forced vital capacity (FVC) at week 52

    Time frame: day 1 and week 52

    FVC is a standard pulmonary function test used to quantify respiratory muscle weakness

Study contacts

Contact information is provided by the study sponsor or research team.

Sun luyin

CONTACT

[email protected]

028-67258779

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: PPF

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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