Not Yet RecruitingPhase 3

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

378 participantsStarted 2026-04-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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:
✓.on stable therapy with nintedanib or pirfenidone for at least 12 weeks prior to screening and during the screening period.
✓.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.

What they're measuring

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

Timeframe: day 1 and week 52

Trial details

NCT IDNCT07503587

SponsorHaisco Pharmaceutical Group Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12-30

Contact for this trial

Sun luyin

028-67258779 sunluyin@haisco.com

View on ClinicalTrials.gov More Progressive Pulmonary Fibrosis trials