Actively Recruiting
SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
Led by Guangzhou JOYO Pharma Co., Ltd · Updated on 2024-11-19
210
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.
CONDITIONS
Official Title
SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) less than 5 years before enrollment
- Diagnosis confirmed by HRCT pattern and, if available, surgical lung biopsy assessed by central reviewers
- Diffusing capacity for carbon monoxide (Dlco), corrected for hemoglobin, between 30% and 90% of predicted normal
- Forced vital capacity (FVC) 50% or more of predicted normal
You will not qualify if you...
- Forced expiratory volume in one second (FEV1)/FVC ratio less than 0.7 after bronchodilator at screening
- Expected lung transplant within 1 year or on lung transplant waiting list (for US sites) at randomization
- Known cause of interstitial lung disease other than IPF
- History of asthma or chronic obstructive pulmonary disease
- Active infection at screening
- Current use of IPF treatments including investigational therapy, immunosuppressants, or cytokine modulating agents
- History of unstable or worsening cardiac or pulmonary disease (other than IPF) within past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100703
Actively Recruiting
Research Team
Z
zuojun xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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