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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.

Key facts

Study ID

NCT06125327

Run by

Guangzhou JOYO Pharma Co., Ltd

People needed

210

Starts

2023-06-06

Expected to finish

2027-12-31

Last updated by the study team

2024-11-19

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.