About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥18 year.
Diagnosis of PPF other than IPF prior to screening or during the screening period.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
HSK44459
DrugHSK44459 taken orally twice daily in the morning and in the evening for 52weeks.
Placebo
DrugPlacebo matching HSK44459 taken orally twice daily in the morning and in the evening for 52 weeks
Treatment groups
Trial outcomes
Primary outcomes
The change from baseline in forced vital capacity (FVC) at week 52
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: