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Clinical Trials in China / NCT06125327
Recruiting Phase 2/3

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

NCT06125327 · tracked via the Priya Life Science China tracker
Sponsor
Guangzhou JOYO Pharma Co., Ltd
Phase
Phase 2/3
Started
2023-06-06
Last updated
2024-11-19

Condition(s) studied

Idiopathic Pulmonary Fibrosis

Investigational drug(s) / intervention(s)

SC1011Placebo comparator

SC1011: Patients receive the dose of SC1011 tablets orally twice daily (b.i.d) for 52 weeks.

Placebo comparator: Patients receive the dose of placebo orally twice daily (b.i.d) for 52 weeks.

Study summary

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

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing Beijing Municipality Recruiting

More Guangzhou JOYO Pharma Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06125327 on ClinicalTrials.gov ↗ ← All trials in China