About this trial
Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- SC1011
- Placebo comparator