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

Study Purpose

The goal of this clinical trial is to evaluate the efficacy and safety of Sufenidone (SC1011) in patients with IPF, and to provide a new safe and effective treatment option for patients with IPF. Participants will complete the study including screening period, treating period, and follow-up period. Investigators will compare the annual rate of decline in FVC to see if it is an optional new drug. The participants have lung function tests at study visits. The results of the lung function tests are compared between the SC1011 groups and the placebo group. The doctors also regularly check the general health of the participants.

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

This is a randomized, double-blind, placebo-controlled study using a phase II/III adaptive seamless design. The study isdivided into three treatment groups: two active treatment groups and one placebo group. An interim analysis will be performed after the completion of 26 weeks of treatment in 75 patients. According to the safety and efficacy results analyzed, the appropriate active dose will be selected. Subjects will be divided into 3 treatment groups in a ratio of 1:1:1; After the interim analysis, if the DMC selected a treatment dose, all new recruits would be randomly assigned to the treatment and placebo groups in a 2:1 ratio. Subjects who were enrolled before the interim analysis will be adjusted to continue treatment at the selected dose up to 52 weeks. This study includes screening period, treatment period and follow-up period. During the screening period, the subjects' lung imaging examinations performed at different centers required a central imaging diagnosis. The first dose after randomization is D1, and the treatment period for each subject is 52 weeks. All subjects will have a 4-week safety follow-up period after the end of treatment. Subjects who do not complete 52 weeks of treatment will also have a 4-week safety follow-up after the final dosing date.

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

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.