Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT05321420
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-16
First Post:
2022-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D012120', 'term': 'Respiration Disorders'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093844', 'term': 'pirfenidone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'dispFirstSubmitDate': '2025-10-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2022-04-02', 'studyFirstSubmitQcDate': '2022-04-02', 'dispFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of decline in Forced Vital Capacity over 26 weeks (Part A)', 'timeFrame': '26 weeks', 'description': 'Rate of decline in Forced Vital Capacity (FVC; in mL)'}], 'secondaryOutcomes': [{'measure': 'Forced Vital Capacity (FVC) percent predicted change (Part A)', 'timeFrame': 'Baseline to Week 26', 'description': 'FVC percent predicted (FVCpp) change from baseline to Week 26'}, {'measure': 'Time to hospitalization or mortality (Part A)', 'timeFrame': '26 weeks', 'description': 'Time to hospitalization or mortality due to respiratory cause through 26 weeks'}, {'measure': 'Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part A)', 'timeFrame': '26 weeks', 'description': 'Time to IPF progression through 26 weeks, as defined by a decline in FVC% of 5% or greater or death'}, {'measure': 'Forced Vital Capacity (FVC) percent predicted change (Part B)', 'timeFrame': '26 Weeks', 'description': 'FVC percent predicted (FVCpp) change from Week 26 to Week 52'}, {'measure': 'Rate of decline in Forced Vital Capacity over 26 weeks (Part B)', 'timeFrame': '26 Weeks', 'description': 'Rate of decline in Forced Vital Capacity (FVC; in mL) from Week 26 to Week 52'}, {'measure': 'Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part B)', 'timeFrame': '26 Weeks', 'description': 'Time to IPF progression from Week 26 to Week 52, as defined by a decline in FVC% of 5% or greater or death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IPF', 'lung fibrosis', 'respiratory disease'], 'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.elevateipf.com', 'label': 'Recruiting website for patients in the United States'}]}, 'descriptionModule': {'briefSummary': 'This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.', 'detailedDescription': 'This study is a randomized, double-blind, being conducted at centers globally to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in 240 treatment naïve adult patients with IPF ≥ 40 years in age. Patients will be randomized in a ratio of 1:1:1:1 to receive treatment of LYT-100, pirfenidone, or placebo to be taken daily for up to 183 days (26 week treatment period) with the primary outcome of Rate of decline in Forced Vital Capacity (FVC; in mL) over 26 weeks. Secondary endpoints, including spirometry, inflammatory biomarkers, and patient-reported outcomes will also be evaluated.\n\nAfter completion of the double-blind period of the study, patients may participate in a long-term extension to evaluate tolerability and long-term safety. Patients receiving LYT-100 in the double-blind period will continue the dose throughout the long-term extension. Patients receiving pirfenidone or placebo in the double-blind period will be re-randomized in a 1:1 ratio to receive LYT-100 550mg or 825mg TID dose throughout the long-term extension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Treatment naïve patients or those with \\<6 months of exposure to nintedanib with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines\n* Idiopathic Pulmonary Fibrosis on HRCT, performed within 12 months of Visit 1 as confirmed by central readers\n* DLCO corrected for Hemoglobin (Hb) \\[visit 1\\] ≥ 30% and ≤90% of predicted of normal\n* FVC ≥ 45% of predicted normal\n\nKey Exclusion Criteria:\n\n* Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC \\< 0.7 at Visit 1)\n* Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer\n* Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis\n* Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion)\n* Cardiovascular diseases, any of the following:\n\n * Uncontrolled hypertension, within 3 months of Visit 1\n * Myocardial infarction within 6 months of Visit 1\n * Unstable cardiac angina within 6 months of Visit 1\n* Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection within 3-months of Visit 1'}, 'identificationModule': {'nctId': 'NCT05321420', 'acronym': 'ELEVATE', 'briefTitle': 'LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'PureTech'}, 'officialTitle': 'A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)', 'orgStudyIdInfo': {'id': 'LYT-100-2022-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo oral administration', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pirfenidone 801 mg TID', 'description': 'pirfenidone 801 mg TID oral administration', 'interventionNames': ['Drug: Pirfenidone']}, {'type': 'EXPERIMENTAL', 'label': 'LYT-100 550 mg TID', 'description': 'LYT-100 (Deupirfenidone) 550 mg TID oral administration', 'interventionNames': ['Drug: Deupirfenidone']}, {'type': 'EXPERIMENTAL', 'label': 'LYT-100 825 mg TID', 'description': 'LYT-100 (Deupirfenidone) 825 mg TID oral administration', 'interventionNames': ['Drug: Deupirfenidone']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Placebo']}, {'name': 'Pirfenidone', 'type': 'DRUG', 'description': 'pirfenidone 801 mg TID', 'armGroupLabels': ['pirfenidone 801 mg TID']}, {'name': 'Deupirfenidone', 'type': 'DRUG', 'description': 'Deupirfenidone', 'armGroupLabels': ['LYT-100 550 mg TID', 'LYT-100 825 mg TID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90230', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Science 37', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'NewportNativeMD, Inc.', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '96001', 'city': 'Redding', 'state': 'California', 'country': 'United States', 'facility': 'Paradigm Clinical Research Centers, Inc.', 'geoPoint': {'lat': 40.58654, 'lon': -122.39168}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Accel Research Sites Network', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Harmony Medical Research Institute, Inc', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Healthcare, Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Investments', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '27403', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pulmonix', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Southeastern Research Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37067', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Trials Center of Middle Tennessee', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '37204', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75204', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77380', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Renovatio Clinical - The Woodlands Research Center', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '23230', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Pulmonary Associates of Richmond', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23188', 'city': 'Williamsburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'TPMG Clinical Research', 'geoPoint': {'lat': 37.2707, 'lon': -76.70746}}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Instituto Médico de la Fundación de Estudios Clinicos / Fundación Estudios', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '1406', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Aprillus Asistencia e Investigación', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1602', 'city': 'Buenos Aires', 'country': 'Argentina', 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'country': 'Argentina', 'facility': 'INSARES - Instituto de Salud Respiratoria', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': 'M5500', 'city': 'Mendoza', 'country': 'Argentina', 'facility': 'Centro Médico Dharma', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': '1888', 'city': 'San Juan Bautista', 'country': 'Argentina', 'facility': 'Instituto de Enfermedades Respiratorias e Investigación Clínica', 'geoPoint': {'lat': -34.80896, 'lon': -58.27623}}, {'zip': '4000', 'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'Investigaciones en Patologías Respiratorias', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '3000', 'city': 'Santa Fe', 'country': 'Argentina', 'facility': 'Instituto del Buen Aire', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'zip': '8336', 'city': 'Villa Regina', 'country': 'Argentina', 'facility': 'Clinica Central S.A.', 'geoPoint': {'lat': -39.09631, 'lon': -67.08374}}, {'zip': '3530000', 'city': 'Maule', 'country': 'Chile', 'facility': 'Clinica Maule', 'geoPoint': {'lat': -35.52249, 'lon': -71.68891}}, {'zip': '7550000', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Centro de Estudios Clinicos', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7550000', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Clinica Universidad de Los Andes', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Valparaíso', 'country': 'Chile', 'facility': 'Centro Respiratorio Integral', 'geoPoint': {'lat': -33.036, 'lon': -71.62963}}, {'city': 'Armenia', 'country': 'Colombia', 'facility': 'Fundacion Cardiomet CEQUIN', 'geoPoint': {'lat': 4.53656, 'lon': -75.67263}}, {'city': 'Bucaramanga', 'country': 'Colombia', 'facility': 'Instituto Neumologico del Oriente S.A.', 'geoPoint': {'lat': 7.125, 'lon': -73.11895}}, {'zip': '760036', 'city': 'Cali', 'country': 'Colombia', 'facility': 'Centro de Investigaciones Clinicas S.A.S', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'zip': '0101', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'National Ceneter for Tuberculosis and Lung Diseases JSC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0144', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0159', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Emergency Cardiology Center by Academician G. Chapidze LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0160', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LTD Aversi Clinic', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0180', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LTD The First Medical Center', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '68100', 'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'University Hospital Alexandroupolis', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': '"Sotiria" Chest Diseases Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '12462', 'city': 'Athens', 'country': 'Greece', 'facility': 'University General Hospital "Attikon"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '15125', 'city': 'Athens', 'country': 'Greece', 'facility': 'Athens Medical Center', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '26504', 'city': 'Pátrai', 'country': 'Greece', 'facility': 'University General Hospital of Patras', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'zip': '57010', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'General Hospital of Thessaloniki "G. 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