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SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)

Study Purpose

Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06125327
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Guangzhou JOYO Pharma Co., Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Additional Details

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

Arms & Interventions

Arms

Placebo Comparator: Placebo Comparator

Idiopathic pulmonary fibrosis (IPF) patients were administered placebo matching SC1011 taken orally as tablets (matching the respective SC1011 tablets) twice daily, in the morning and in the evening for 52 weeks.

Experimental: SC1011 200mg

Idiopathic pulmonary fibrosis (IPF) patients were administered SC1011 taken orally as tablets twice daily(200mg daily), in the morning and in the evening for 52 weeks.

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.

Contact a Trial Team

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