[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614823":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":30,"collaborators":26,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":26,"enrollmentInfo":42,"targetDuration":26,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":57,"whyStopped":26,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":26},{"fullName":5,"class":6},"PureTech","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active","EXPERIMENTAL","deupirfenidone 825 mg TID",[13],"Drug: Deupirfenidone",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator","ACTIVE_COMPARATOR","pirfenidone 801 mg TID",[19],"Drug: Pirfenidone (PFD)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Deupirfenidone","size AA Swedish orange capsule",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Pirfenidone (PFD)",[15],{"type":31,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100614823","phase-3-trial-to-evaluate-the-efficacy-and-safety-of-lyt-100-deupirfenidone-compared-to-pirfenidone-in-adults-with-idiopathic-pulmonary-fibrosis-ipf-100614823",false,"NCT07284602","Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)","A Randomized, Double-Blind, Head-to-Head Phase 3 Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone at 52 Weeks in Adults With Idiopathic Pulmonary Fibrosis (SURPASS-IPF)","SURPASS-IPF","Inclusion Criteria:\n\n* Is ≥40 years of age at the time of informed consent.\n* Meets the diagnostic criteria of IPF American Thoracic Society (ATS)\u002FEuropean Respiratory Society (ERS)\u002FJapanese Respiratory Society (JRS)\u002FLatin American Thoracic Society (ALAT) 2022 guidelines.\n* Has a maximum time from initial IPF diagnosis of 7 years.\n* Has no prior exposure to pirfenidone or LYT-100, and has \\\u003C12 months of prior exposure to nintedanib or any other approved antifibrotic therapies.\n* Has definite or probable unusual interstitial pneumonia (UIP) on HRCT, performed within 12 months prior to Visit 1 and confirmed by the central reader.\n* Has an FVC ≥45% of predicted normal at Visit 1.\n\nExclusion Criteria:\n\n* Has, in the opinion of the Investigator, significant clinical worsening of IPF between Visit 1 and Visit 2.\n* Has been hospitalized within 3 months prior to Visit 1 for acute exacerbation of IPF or other significant respiratory complication.\n* Has prebronchodilator forced expiratory volume in 1 second (FEV1)\u002FFVC \\\u003C0.7 at Visit 1.\n* Has a greater extent of emphysema vs fibrosis on the most recent HRCT scan as confirmed by the central reader.\n* Has a diagnosis of any condition that could be an explanation for interstitial lung disease (ILD).\n* Has a major extrapulmonary condition that could affect spirometry.\n* Has a current diagnosis of other relevant respiratory disorders.\n* Has significant pulmonary hypertension (PH).\n* Has had a lung transplant.\n* Has cardiovascular disease.\n* Has underlying chronic liver disease\u002Fimpairment.\n* Has relevant chronic or acute infections including active viral hepatitis or poorly controlled HIV.\n* Has had any major surgical procedures performed within 6 weeks prior to Visit 1 or is planning to have a major surgical procedure during the study.\n* Has any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1.\n* Has any of the following laboratory abnormalities at Visit 1:\n\n  * Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\>1.5 × upper limit of normal (ULN).\n  * Total bilirubin \\>1.5 × ULN. Exceptions may be made on a case-by-case basis for participants with Gilbert's syndrome in consultation with the Medical Monitor.\n  * Creatinine clearance \\\u003C30 mL\u002Fmin calculated by Cockcroft-Gault formula.\n* Is currently taking prednisone at a steady dose \\>10 mg\u002Fday or equivalent (a steady dose ≤10 mg\u002Fday is not exclusionary but the individual must be on a stable dose for at least 30 days prior to Visit 2).\n* Use of any tobacco or combustible cannabis products within 3 months prior to Visit 1 or is unable to refrain from use during the trial.\n* Has known symptoms of dysphagia, difficulty in swallowing capsules or tablets, or has had a total gastrectomy.\n* Is currently enrolled in another clinical study (except observational\u002Fregistry or biobank studies) or has used any investigational drug or device within 90 days prior to Visit 1.\n* Has ever received stem cell therapy for the treatment of pulmonary fibrosis.\n* Is currently pregnant, breastfeeding, or is planning to become pregnant during the study.\n* Has had any prior exposure to LYT-100 or pirfenidone (even one dose).","ALL","40 Years",{"count":43,"type":44},1100,"ESTIMATED","INTERVENTIONAL",[47],"PHASE3","This is a study for adults with a lung disease called idiopathic pulmonary fibrosis. The main purpose of this study is to look at how well deupirfenidone improves lung function and how safe it is for people with idiopathic pulmonary fibrosis (IPF) when compared with pirfenidone. Participants may have been treated with an approved antifibrotic drug for up to a year in the past, but they cannot be on background antifibrotic treatment during this study. Participants will be randomly assigned (meaning by chance) to take either deupirfenidone or pirfenidone 3 times a day, and neither a participant nor their study team will know which study drug participants are on. Participants will be in the study for up to approximately 3 years. During the first year, participants visit the study site up to ten times and afterwards they visit the site every three months. All participants will remain on blinded study drug until the last participant has completed Week 52 Visit. They will have lung function tests, a check of their health, and will tell the study team about any unfavorable effects.",[50],"Idiopathic Pulmonary Fibrosis (IPF)",[52,53,54,23,55,56],"Idiopathic Pulmonary Fibrosis","IPF","Pulmonary Fibrosis","Pirfenidone","Lung Disease","NOT_YET_RECRUITING","2025-12-18",{"date":60,"type":61},"2025-12-22","ACTUAL",{"date":63,"type":44},"2026-04",{"date":65,"type":44},"2029-07",{"name":5,"class":6}]