SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SC1011, Placebo comparator.
- Who it may be relevant to
- Registry conditions: Idiopathic Pulmonary Fibrosis. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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).
Overview
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
- 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.
Primary outcome measures
- Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks [Time frame: Primary Outcome measures will be assessed at baseline and again at 52 weeks.]
Secondary outcome measures (2)
- Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks [Time frame: Baseline and 52 weeks]
- Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation. [Time frame: Secondary outcome measures will be assessed at baseline and again at 52 weeks.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT06125327 · JYP1011M201