Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.
Randomized, double-blind study comparing Sufenidone (SC1011) and placebo in IPF patients, with interim analysis at 26 weeks to select the optimal dose for a 52-week treatment period followed by 4-week safety monitoring
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
Patients receive the dose of SC1011 tablets orally twice daily (b.i.d) for 52 weeks.
Patients receive the dose of placebo orally twice daily (b.i.d) for 52 weeks.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGAnnual 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.
Time frame: Primary Outcome measures will be assessed at baseline and again at 52 weeks.
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 frame: Baseline and 52 weeks
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.
Time frame: Secondary outcome measures will be assessed at baseline and again at 52 weeks.
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