[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525714":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":34,"studyPopulation":22,"armGroups":35,"interventions":48,"overallOfficials":22,"centralContacts":62,"locations":68,"responsibleParty":86,"collaborators":22,"id":88,"slug":22,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":22,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":22,"studyType":100,"phases":101,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":71,"whyStopped":22,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Guangzhou JOYO Pharma Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks","Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.","Primary Outcome measures will be assessed at baseline and again at 52 weeks.",[14,18],{"measure":15,"description":16,"timeFrame":17},"Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks","SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status. Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)","Baseline and 52 weeks",{"measure":19,"description":20,"timeFrame":21},"Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation.","Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint.","Secondary outcome measures will be assessed at baseline and again at 52 weeks.",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":29},"QUADRUPLE",[30,31,32,33],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"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.",[41],"Drug: Placebo comparator",{"label":43,"type":44,"description":45,"interventionNames":46},"SC1011 200mg","EXPERIMENTAL","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.",[47],"Drug: SC1011",[49,56],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DRUG","SC1011","Patients receive the dose of SC1011 tablets orally twice daily (b.i.d) for 52 weeks.",[43],[55],"Active Drug",{"type":50,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Placebo comparator","Patients receive the dose of placebo orally twice daily (b.i.d) for 52 weeks.",[37],[61],"comparator",[63],{"name":64,"role":65,"phone":66,"phoneExt":22,"email":67},"zuojun xu","CONTACT","+86 010-69156114","Xuzj@hotmail.com",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Peking Union Medical College Hospital","RECRUITING","Beijing","Beijing Municipality","100703","China","CN",{"type":78,"coordinates":79},"Point",[80,81],116.39723,39.9075,{"lat":81,"lon":80},[84],{"name":85,"role":65,"phone":66,"phoneExt":22,"email":67},"Zuojun Xu, Medical Doctor",{"type":87,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100525714",false,"NCT06125327","SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)","A Randomized, Double-blind, Placebo-controlled Phase II\u002FIII Trial Evaluating the Efficacy and Safety of Sufenidone (SC1011) Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF).","Inclusion Criteria:\n\n* Ability to understand and sign written informed consent.\n* The diagnosis time of IPF before enrollment was less than 5 years.\n* 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.\n* Dlco (corrected for Hb): 30%-90% predicted of normal.\n* FVC\\>= 50% predicted of normal.\n\nExclusion Criteria:\n\n* Forced expiratory volume in one second (FEV1)\u002FFVC ratio \\\u003C0.7 after administration of bronchodilator at Screening\n* 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.\n* Known explanation for interstitial lung disease\n* History of asthma or chronic obstructive pulmonary disease\n* Active infection\n* Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents\n* History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months","ALL","40 Years","80 Years",{"count":98,"type":99},210,"ESTIMATED","INTERVENTIONAL",[102,103],"PHASE2","PHASE3","Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.",[106],"Idiopathic Pulmonary Fibrosis",[108,106,109,110],"Pulmonary Fibrosis","Lung Diseases","Respiratory Tract Diseases","2024-11-15",{"date":113,"type":114},"2024-11-19","ACTUAL",{"date":116,"type":114},"2023-06-06",{"date":118,"type":99},"2027-12-31",{"name":5,"class":6},1]