Idiopathic Pulmonary Fibrosis
Conditions
Keywords
Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Lung Diseases, Respiratory Tract Diseases
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 safety monitoring
Interventions
DRUGSC1011
Patients receive the dose of SC1011 tablets orally twice daily (b.i.d) for 52 weeks.
DRUGPlacebo comparator
Patients receive the dose of placebo orally twice daily (b.i.d) for 52 weeks.
Sponsors
Guangzhou JOYO Pharma Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks | Primary Outcome measures will be assessed at baseline and again at 52 weeks. | Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks | Baseline and 52 weeks | SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status. Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52) |
| Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation. | Secondary outcome measures will be assessed at baseline and again at 52 weeks. | Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. |
Countries
China
Contacts
Primary Contactzuojun xu
Outcome results
None listed