Overview
The goal of this clinical trial is to evaluate the efficacy and safety of Sufenidone (SC1011) in patients with IPF, and to provide a new safe and effective treatment option for patients with IPF. Participants will complete the study including screening period, treating period, and follow-up period. Investigators will compare the annual rate of decline in FVC to see if it is an optional new drug. The participants have lung function tests at study visits. The results of the lung function tests are compared between the SC1011 groups and the placebo group. The doctors also regularly check the general health of the participants.
Description
This is a randomized, double-blind, placebo-controlled study using a phase II/III adaptive seamless design. The study isdivided into three treatment groups: two active treatment groups and one placebo group. An interim analysis will be performed after the completion of 26 weeks of treatment in 75 patients. According to the safety and efficacy results analyzed, the appropriate active dose will be selected. Subjects will be divided into 3 treatment groups in a ratio of 1:1:1; After the interim analysis, if the DMC selected a treatment dose, all new recruits would be randomly assigned to the treatment and placebo groups in a 2:1 ratio. Subjects who were enrolled before the interim analysis will be adjusted to continue treatment at the selected dose up to 52 weeks.
This study includes screening period, treatment period and follow-up period. During the screening period, the subjects' lung imaging examinations performed at different centers required a central imaging diagnosis. The first dose after randomization is D1, and the treatment period for each subject is 52 weeks. All subjects will have a 4-week safety follow-up period after the end of treatment. Subjects who do not complete 52 weeks of treatment will also have a 4-week safety follow-up after the final dosing date.
Eligibility
Inclusion Criteria:
- 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.
- FVC>= 50% predicted of normal.
Exclusion Criteria:
- 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
- Active infection
- Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
- History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months