Evaluating the Efficacy and Safety of of HSK50042 in People With Idiopathic Pulmonary Fibrosis

Korábbi kezelés

• Acute IPF exacerbation within 3 months prior to screening and/or during the screening period (investigator-determined).
• History of persistent or active micturition/defecation syncope, known prior history of syncope, or concomitant other diseases increasing the risk of syncope (e.g., symptomatic bradycardia, second- or third-degree atrioventricular block, symptomatic valvular heart disease, etc.).
• Major surgery (major according to the investigator's assessment) performed within 3 months prior to screening or planned during the course of the trial. (Being on a transplant list is allowed).
• Uncontrolled hypertension at screening or prior to randomization/investigational product administration (defined as refractory hypertension as assessed by the investigator, systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg); or hypotension (seated systolic blood pressure <100 mmHg or diastolic blood pressure <60 mmHg).
• Administration of systemic corticosteroids equivalent to >15 mg prednisone per day within 4 weeks prior to screening and/or during the screening period.

Egyéb

• 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.

• Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) prior to screening, patients must meet both of the following criteria:
• IPF based on 2022 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest HRCT scan taken before or during screening period and if available surgical lung biopsy.
• Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by the investigator prior to screening. if indeterminate HRCT finding IPF may be confirmed locally by (historical) biopsy.
• Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 3. Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin [Hb]) ≥ 25% and<90% of predicted normal at screening period.
• Patients have to be either:
• 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 anti fibrotic therapy.
• on stable therapy with nintedanib or pirfenidone or nerandomilast for at least 12 weeks prior to screening and during the screening period.