Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:15 PM
Study NCT ID:
NCT07222332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596027', 'term': 'baricitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-10-27', 'studyFirstSubmitQcDate': '2025-10-27', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in C-peptide Area Under the Curve (AUC)', 'timeFrame': 'Baseline, Week 52'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change from Baseline in Number of Manual Insulin Boluses', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Rate of Clinically Significant Hypoglycemic Events', 'timeFrame': 'Baseline through Week 52', 'description': 'Measured by continuous glucose monitoring and serious adverse event reporting'}, {'measure': 'Change from Baseline in Fasting C-Peptide', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change from Baseline in Height', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change from Baseline in Mean Total Daily Insulin Dose', 'timeFrame': 'Baseline, Week 52', 'description': 'Measured during the two weeks prior to the assessment'}, {'measure': 'Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2)', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change from Baseline in Matsuda Index', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib', 'timeFrame': 'Predose through Week 16'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T1DM', 'Children', 'New-onset', 'Beta-cell Function'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/662877', 'label': 'A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention\n* Have at least one diabetes-related autoantibody found at screening\n* Show signs of remaining beta-cell function\n\n * stimulated (peak or 90 min) C-peptide ≥0.2 nmol/L (0.6 ng/mL) at screening, or\n * random C-peptide result \\>0.3 nmol/L (0.9 ng/mL) during the screening period\n* Weigh at least 8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes including gestational\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious medical condition or infection'}, 'identificationModule': {'nctId': 'NCT07222332', 'briefTitle': 'A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years', 'orgStudyIdInfo': {'id': '27405'}, 'secondaryIdInfos': [{'id': '2025-522170-36-00', 'type': 'CTIS'}, {'id': 'I4V-MC-JAJK', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baricitinib', 'description': 'Participants will receive baricitinib orally', 'interventionNames': ['Drug: Baricitinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo orally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Baricitinib', 'type': 'DRUG', 'otherNames': ['LY3009104'], 'description': 'Administered orally', 'armGroupLabels': ['Baricitinib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '303-724-3861'}, {'name': 'Andrea Steck', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Barbara Davis Center for Childhood Diabetes', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '267-426-7037'}, {'name': 'Steven Willi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Philadelphia (CHOP)", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78411', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '361-739-7250'}, {'name': 'Ana Paez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Driscoll Children's Hospital", 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '434-924-5956'}, {'name': 'Christine Burt Solorzano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '5006', 'city': 'Adelaide', 'country': 'Australia', 'contacts': [{'name': 'Jennifer Couper', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Women's and Children's Hospital", 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '4101', 'city': 'Brisbane', 'country': 'Australia', 'contacts': [{'name': 'Tony Huynh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Centre for Children's Health Research", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '3081', 'city': 'Heidelberg West', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '0394962160'}, {'name': 'Elif Ekinci', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Austin Health - Repatriation Hospital', 'geoPoint': {'lat': -37.73922, 'lon': 145.04034}}, {'zip': '4305', 'city': 'Ipswich', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '0402112100'}, {'name': 'Thomas Dover', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ipswich Hospital', 'geoPoint': {'lat': -27.62343, 'lon': 152.76067}}, {'zip': '3052', 'city': 'Melbourne', 'country': 'Australia', 'contacts': [{'name': 'Fergus Cameron', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Royal Children's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '5046', 'city': 'Oaklands Park', 'country': 'Australia', 'contacts': [{'name': 'Natalie Giles', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Adelaide Diabetes & Endocrine Services', 'geoPoint': {'lat': -35.00671, 'lon': 138.54457}}, {'zip': '3050', 'city': 'Parkville', 'country': 'Australia', 'contacts': [{'name': 'John Wentworth', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6009', 'city': 'Perth', 'country': 'Australia', 'contacts': [{'name': 'Elizabeth Davis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Perth Children's Hospital", 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '2031', 'city': 'Randwick', 'country': 'Australia', 'contacts': [{'name': 'Kristen Neville', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Sydney Children's Hospital", 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2145', 'city': 'Westmead', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '02 9845 3171'}, {'name': 'Ann Maguire', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '3225556305'}, {'name': 'Miriam Cnop', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Université Libre de Bruxelles - Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '0475956681'}, {'name': 'Willem Staels', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '3227647052'}, {'name': 'Philippe Lysy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '0032 8214364'}, {'name': 'Christophe De Block', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'contacts': [{'name': 'Imke Matthys', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '+3216346994'}, {'name': 'Chantal Mathieu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '00 32 4 323 34 13'}, {'name': 'jean-christophe philips', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '5000', 'city': 'Namur', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '+32-81-720505'}, {'name': 'Dominique Beckers', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU UCL Namur/Site Sainte Elisabeth', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'zip': '5530', 'city': 'Yvoir', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '+32-81-720505'}, {'name': 'Dominique Beckers', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': '79080-190', 'city': 'Campo Grande', 'country': 'Brazil', 'contacts': [{'name': 'Delcio da Silva Junior', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitário Maria Aparecida Pedrossian', 'geoPoint': {'lat': -20.44278, 'lon': -54.64639}}, {'zip': '80045170', 'city': 'Curitiba', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'phone': '5541999736442'}, {'name': 'Rosangela Rea', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Quanta Diagnóstico e Terapia', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '80810-040', 'city': 'Curitiba', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'phone': '554130231252'}, {'name': 'André Vianna', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Diabetes Curitiba', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '60175-047', 'city': 'Fortaleza', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'phone': '5585996190895'}, {'name': 'ADRIANA FORTI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro De Diabetes Metabolismo E Endocrinologia', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '74230-035', 'city': 'Goiânia', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'phone': '5562992240229'}, {'name': 'Nelson Rassi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cendi - Endocrinologia e Diabetes', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '17504-072', 'city': 'Marília', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'phone': '55 14 21051477'}, {'name': 'José Sgarbi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Pesquisa Clínica de Marília - CPCLIM', 'geoPoint': {'lat': -22.21389, 'lon': -49.94583}}, {'zip': '91350-250', 'city': 'Porto Alegre', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'phone': '55133372215'}, {'name': 'Balduino Tschiedel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto da Crianca com Diabetes', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '14051-140', 'city': 'Ribeirão Preto', 'country': 'Brazil', 'contacts': [{'name': 'Raphael Liberatore', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '21941-590', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'contacts': [{'name': 'Melanie Rodacki', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universidade Federal do Rio de Janeiro', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '01223-001', 'city': 'São Paulo', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'phone': '551127370277'}, {'name': 'Joao Salles', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto de Pesquisa Clinica', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '01228-200', 'city': 'São Paulo', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'phone': '551126303777'}, {'name': 'Denise Franco', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CPCLIN', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04038-032', 'city': 'São Paulo', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'phone': '551197116-9844'}, {'name': 'Monica Gabbay', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IBTED - 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'country': 'United Kingdom', 'contacts': [{'name': 'Sam Philip', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'country': 'United Kingdom', 'contacts': [{'name': 'Renuka Dias', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Birmingham Children's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BS10 5NB', 'city': 'Bristol', 'country': 'United Kingdom', 'contacts': [{'role': 'CONTACT', 'phone': '01174148125'}, {'name': 'Danijela Tatovic', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southmead Hospital', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'contacts': [{'name': 'Loredana Marcovecchio', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'country': 'United Kingdom', 'contacts': [{'name': 'Colin Dayan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'country': 'United Kingdom', 'contacts': [{'role': 'CONTACT', 'phone': '01865857226'}, {'name': 'Katharine Owen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'contacts': [{'role': 'CONTACT', 'phone': '02381208518'}, {'name': 'Nicola Trevelyan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'centralContacts': [{'name': 'There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or', 'role': 'CONTACT', 'email': 'clinical_inquiry_hub@lilly.com', 'phone': '317-615-4559'}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY 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