RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
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).
About This Trial
Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.
Who May Be Eligible (Plain English)
Who May Qualify:
- Ability to understand and sign written willing to sign a consent form.
- 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.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
SC1011
Patients receive the dose of SC1011 tablets orally twice daily (b.i.d) for 52 weeks.
DRUG
Placebo comparator
Patients receive the dose of placebo orally twice daily (b.i.d) for 52 weeks.
Locations (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China