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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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