Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.
Ability to understand and sign written informed consent.
The diagnosis time of IPF before enrollment was less than 5 years.
Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF.
Dlco (corrected for Hb): 30%-90% predicted of normal.
Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 after administration of bronchodilator at Screening
Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization.
Known explanation for interstitial lung disease
History of asthma or chronic obstructive pulmonary disease
Parallel
SC1011
DrugPatients receive the dose of SC1011 tablets orally twice daily (b.i.d) for 52 weeks.
Placebo comparator
DrugPatients receive the dose of placebo orally twice daily (b.i.d) for 52 weeks.
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.
Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks
SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status. Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation.
Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint.
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