Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-02 @ 8:20 AM
Study NCT ID:
NCT06869551
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-03-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first flare during the withdrawal period', 'timeFrame': 'From week 16 up to week 42'}], 'secondaryOutcomes': [{'measure': 'Trough concentration at steady state (Cminss)', 'timeFrame': 'At week 16'}, {'measure': 'Time-averaged steady-state concentration (Cavgss)', 'timeFrame': 'At week 16'}, {'measure': 'Steady-state maximum observed concentration (Cmaxss)', 'timeFrame': 'At week 16'}, {'measure': 'Number of participants with flare during the withdrawal period', 'timeFrame': 'From week 16 up to week 42'}, {'measure': 'Number of participants achieving each of American College of Rheumatology (ACR) Pedi (30/50/70/90)', 'timeFrame': 'At week 16 and week 42'}, {'measure': 'Change from baseline in juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) Pedi Core Criteria', 'timeFrame': 'At week 16 and week 42'}, {'measure': 'Number of participants achieving low disease activity (Juvenile arthritis disease activity 71-joint score based on C-reactive protein (JADAS71-CRP) score: for oligoarthritis 1.1 to 2; for polyarthritis 1.1 to 3.8)', 'timeFrame': 'At week 16 and week 42'}, {'measure': 'Number of participants achieving inactive disease (JADAS71-CRP score ≤ 1)', 'timeFrame': 'At week 16 and week 42'}, {'measure': 'Number of participants attaining clinical remission for at least 6 consecutive months', 'timeFrame': 'At week 42'}, {'measure': 'Number of participants achieving psoriasis area and severity index (PASI) 75', 'timeFrame': 'At week 42'}, {'measure': 'Number of participants for each assessment who evaluate palatability scale as ≥ 3 (good or better), swallowability scale as ≤ 4 (neutral or easier), and taste scales (Sweetness, Bitterness, Flavor, and Overall Taste) as "None" or "Weak"', 'timeFrame': 'At week 16'}, {'measure': 'Assessment of exposure-response (E-R) utilizing steady-state exposure of deucravacitinib from the pharmacokinetic (PK) analysis and efficacy results using ACR Pedi 30', 'timeFrame': 'At week 16'}, {'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to week 42'}, {'measure': 'Number of participants with adverse event of special interest (AESIs)', 'timeFrame': 'Up to week 42'}, {'measure': 'Number of participants with AEs leading to discontinuation', 'timeFrame': 'Up to week 42'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'Up to week 42'}, {'measure': 'Number of participants with Uveitis', 'timeFrame': 'Up to week 42'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Juvenile Psoriatic Arthritis (JPsA)', 'Juvenile Idiopathic Arthritis (JIA)', 'Pediatric PsA', 'Deucravacitinib', 'BMS-986165'], 'conditions': ['Juvenile Psoriatic Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06869551.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the drug levels, efficacy, and safety of Deucravacitinib (BMS-986165) in pediatric participants with juvenile psoriatic arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Participants must have been diagnosed with Juvenile Psoriatic Arthritis (JPsA).\n* Participants must have at least three joints that are affected by arthritis.\n* Participants must have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems.\n\nExclusion Criteria\n\n* Participants must not have been diagnosed with JPsA before 5 years of age.\n* Participants must not have other types of Juvenile Idiopathic Arthritis (JIA) that aren't JPsA,\n* Participants must not have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months.\n* Other protocol-defined Inclusion/Exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT06869551', 'briefTitle': 'A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Children and Adolescents From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis', 'orgStudyIdInfo': {'id': 'IM011-1071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'interventionNames': ['Drug: Deucravacitinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm B', 'interventionNames': ['Drug: Deucravacitinib', 'Other: Placebo']}], 'interventions': [{'name': 'Deucravacitinib', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0038', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0038', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0020', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0020', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0023', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0023', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '11040', 'city': 'North New Hyde Park', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0059', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0059', 'geoPoint': {'lat': 40.74316, 'lon': -73.69319}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0065', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0065', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0066', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0066', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '78723', 'city': 'Austin', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0036', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0036', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '60140-025', 'city': 'Fortaleza', 'state': 'Ceará', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Site 0068', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0068', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '78020-500', 'city': 'Cuiabá', 'state': 'Mato Grosso', 'status': 'WITHDRAWN', 'country': 'Brazil', 'facility': 'Local Institution - 0032', 'geoPoint': {'lat': -15.59611, 'lon': -56.09667}}, {'zip': '30150-221', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Site 0030', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0030', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '80250-060', 'city': 'Curitiba', 'state': 'Paraná', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Site 0013', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0013', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '80250-060', 'city': 'Curitiba', 'state': 'Paraná', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Site 0072', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0072', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '50670-420', 'city': 'Recife', 'state': 'Pernambuco', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Site 0007', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0007', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '90020-090', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'WITHDRAWN', 'country': 'Brazil', 'facility': 'Local Institution - 0033', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90480-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Site 0008', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0008', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '95588-000', 'city': 'Xangri-lá', 'state': 'Rio Grande do Sul', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Site 0069', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0069', 'geoPoint': {'lat': -29.80083, 'lon': -50.04361}}, {'zip': '04038-002', 'city': 'Vila Clementino', 'state': 'São Paulo-SP', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Site 0073', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0073', 'geoPoint': {'lat': -23.59818, 'lon': -46.64393}}, {'zip': '21941-612', 'city': 'Rio de Janeiro', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Site 0027', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0027', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '01223-001', 'city': 'São Paulo', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Site 0047', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0047', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04022-001', 'city': 'São Paulo', 'status': 'WITHDRAWN', 'country': 'Brazil', 'facility': 'Local Institution - 0010', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '4002', 'city': 'Plovdiv', 'status': 'RECRUITING', 'country': 'Bulgaria', 'contacts': [{'name': 'Krastina Stefanova-Kelly, Site 0054', 'role': 'CONTACT', 'phone': '+359876324578'}], 'facility': 'University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1797', 'city': 'Sofia', 'status': 'NOT_YET_RECRUITING', 'country': 'Bulgaria', 'contacts': [{'name': 'Site 0062', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0062', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '100045', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 0049', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0049', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400065', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuemei Tang, Site 0056', 'role': 'CONTACT', 'phone': '13012352441'}], 'facility': "The Children's Hospital of Chongqing Medical University", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '510620', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 0060', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0060', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haiguo Yu, Site 0052', 'role': 'CONTACT', 'phone': '13770757631'}], 'facility': 'Childrens Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site 0053', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0053', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '310057', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Meiping Lu, Site 0051', 'role': 'CONTACT', 'phone': '13685773988'}], 'facility': "The Children's Hospital of Zhejiang University School of Medicine", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '201102', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Sun, Site 0050', 'role': 'CONTACT', 'phone': '862164931122'}], 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '779 00', 'city': 'Olomouc', 'state': 'Olomoucký kraj', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Katerina Bouchalova, Site 0003', 'role': 'CONTACT', 'phone': '+420602668887'}], 'facility': 'Fakultni nemocnice Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '150 06', 'city': 'Prague', 'state': 'Praha 5', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Rudolf Horvath, Site 0002', 'role': 'CONTACT', 'phone': '420727812317'}], 'facility': 'Fakultni nemocnice v Motole', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '91054', 'city': 'Erlangen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tobias Krickau, Site 0063', 'role': 'CONTACT', 'phone': '091318533118'}], 'facility': 'Kinderklinik des Uni-Klinikums Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '22081', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ivan Foeldvari, Site 0026', 'role': 'CONTACT', 'phone': '00494020923698'}], 'facility': 'Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Site 0025', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0025', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Campania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberta Naddei, Site 0005', 'role': 'CONTACT', 'phone': '00393272022085'}], 'facility': 'University of Naples Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '50139', 'city': 'Florence', 'state': 'Tuscany', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gabriele Simonini, Site 0004', 'role': 'CONTACT', 'phone': '+393297973141'}], 'facility': 'Azienda Ospedaliera Universitaria Meyer IRCCS', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '00917', 'city': 'San Juan', 'status': 'NOT_YET_RECRUITING', 'country': 'Puerto Rico', 'contacts': [{'name': 'Site 0017', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0017', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '400177', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Mihaela Sparchez, Site 0067', 'role': 'CONTACT', 'phone': '+40723400453'}], 'facility': 'Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '700135', 'city': 'Iași', 'state': 'Iaşi', 'status': 'WITHDRAWN', 'country': 'Romania', 'facility': 'Local Institution - 0048', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '247065', 'city': 'Râmnicu Vâlcea', 'state': 'Vâlcea County', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'RAZVAN IONITESCU, Site 0040', 'role': 'CONTACT', 'phone': '0040722557297'}], 'facility': 'Sc Medaudio-Optica Srl', 'geoPoint': {'lat': 45.1, 'lon': 24.36667}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona [Barcelona]', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mireia Corbeto, Site 0046', 'role': 'CONTACT', 'phone': '667517630'}], 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'state': 'Madrid, Comunidad de', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alina Lucica Boteanu, Site 0041', 'role': 'CONTACT', 'phone': '+34913368571'}], 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'LUCIA LACRUZ PEREZ, Site 0042', 'role': 'CONTACT', 'phone': '+34961244792'}], 'facility': 'Hospital Universitari i Politecnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '34098', 'city': 'Istanbul- Fatih', 'state': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ozgur Kasapcopur, Site 0043', 'role': 'CONTACT', 'phone': '+905322129111'}], 'facility': 'Istanbul Universitesi Cerrahpasa'}, {'zip': '06170', 'city': 'Ankara', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Site 0061', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0061', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06230', 'city': 'Ankara', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Site 0044', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0044', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '34766', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Betul Sozeri, Site 0045', 'role': 'CONTACT', 'phone': '+905327629003'}], 'facility': 'Umraniye Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'BMS Clinical Trials Contact Center www.BMSClinicalTrials.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '8559073286'}, {'name': 'First line of the email MUST contain the NCT# and Site#', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'See plan description', 'ipdSharing': 'YES', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html", 'accessCriteria': 'See plan description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}