Tests SC1011 tablets against placebo in people with idiopathic pulmonary fibrosis
Tests SC1011 tablets against a placebo in adults with lung scarring called IPF.
Plain-language title generated from the registry record
Registry title: SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT06125327, who can take part
Where in China
- Peking Union Medical College HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Guangzhou JOYO Pharma Co., Ltd
- Trial code
- NCT06125327
- Record updated
- 19 November 2024
- Original description
Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.Read full original descriptionShow less
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).
Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.
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: 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; 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; Known explanation for interstitial lung disease; History of asthma or chronic obstructive pulmonary disease; Active infection; Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 after administration of bronchodilator at Screening.