Status:
RECRUITING
SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
Guangzhou JOYO Pharma Co., Ltd
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.
Detailed Description
Randomized, double-blind study comparing Sufenidone (SC1011) and placebo in IPF patients, with interim analysis at 26 weeks to select the optimal dose for a 52-week treatment period followed by 4-week...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06125327
Start Date
June 6 2023
End Date
December 31 2027
Last Update
November 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100703