SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou JOYO Pharma Co., Ltd

Criteria

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