Evaluating Sufenidone for Idiopathic Pulmonary Fibrosis
A Randomized, Double-blind, Placebo-controlled Phase II/III Trial Evaluating the Efficacy and Safety of Sufenidone (SC1011) Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF).
This study is testing a new medication called Sufenidone to see if it can help people with Idiopathic Pulmonary Fibrosis breathe better and stay healthier compared to a placebo.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Guangzhou JOYO Pharma Co., Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06125327 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blind study that compares the efficacy and safety of Sufenidone (SC1011) against a placebo in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF). Participants will undergo screening, treatment, and follow-up assessments, with a focus on measuring forced vital capacity (FVC) decline and overall health checks. The study includes an interim analysis at 26 weeks to determine the optimal dose for a 52-week treatment period, followed by a 4-week safety monitoring phase.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Idiopathic Pulmonary Fibrosis within the last 5 years, with specific lung function criteria.
Not a fit: Patients with a known cause of interstitial lung disease or those on a lung transplant waiting list may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from Idiopathic Pulmonary Fibrosis.
How similar studies have performed: Other studies have explored treatments for Idiopathic Pulmonary Fibrosis, but the specific approach of using Sufenidone is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: zuojun xu
- Email: Xuzj@hotmail.com
- Phone: +86 010-69156114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.