SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
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).
Guangzhou JOYO Pharma Co., Ltd
210 participants
Jun 6, 2023
INTERVENTIONAL
Conditions
Summary
Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.
Eligibility
Inclusion Criteria5
- 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 Criteria7
- 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
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Interventions
Patients receive the dose of SC1011 tablets orally twice daily (b.i.d) for 52 weeks.
Patients receive the dose of placebo orally twice daily (b.i.d) for 52 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06125327