NCT06125327 SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
| NCT ID | NCT06125327 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Guangzhou JOYO Pharma Co., Ltd |
| Condition | Idiopathic Pulmonary Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2023-06-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 210 participants in total. It began in 2023-06-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06125327 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Idiopathic Pulmonary Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06125327 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06125327 currently recruiting?
Yes, NCT06125327 is actively recruiting participants. Contact the research team at Xuzj@hotmail.com for enrollment information.
Where is the NCT06125327 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06125327 clinical trial?
NCT06125327 is sponsored by Guangzhou JOYO Pharma Co., Ltd. The trial plans to enroll 210 participants.