SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
Recruiting
Phase 2Phase 3Interventional Study
Idiopathic Pulmonary Fibrosis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
210 (estimated)
Sponsor
Guangzhou JOYO Pharma Co., Ltd · Industry
Who this trial is looking for
This trial is looking for people diagnosed with idiopathic pulmonary fibrosis (IPF) for a research study on a new treatment. Participants will need to go through screenings, receive treatment, and attend follow-up health checks.
Are You a Good Fit for This Trial?
You may be able to join if
I can understand and sign written consent.
I have been diagnosed with IPF for less than 5 years.
My lung scan shows patterns consistent with IPF.
My lung function test results are between 30% and 90% of normal.
My lung capacity is at least 50% of normal.
You may not be able to join if
My lung function ratio is less than 0.7 after taking a bronchodilator.
I expect to receive a lung transplant within the next year.
I have a known cause for my lung disease.
I have a history of asthma or chronic lung disease.
I have an active infection.
I am currently being treated for IPF with other therapies.
I have had unstable heart or lung disease in the past 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.
Trial Locations
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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 reviewer…
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
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