Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Progressive Pulmonary Fibrosis
In brief
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.
Key facts
- Study ID
- NCT07503587
- Run by
- Haisco Pharmaceutical Group Co., Ltd.
- People needed
- 378
- Starts
- 2026-04-05
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-03-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- 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 .
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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