Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT06408259
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607776', 'term': 'ozanimod'}, {'id': 'D000068876', 'term': 'Fingolimod Hydrochloride'}], 'ancestors': [{'id': 'D013110', 'term': 'Sphingosine'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011409', 'term': 'Propylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000588', 'term': 'Amines'}]}}, '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': 194}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2036-07-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2024-05-06', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-04-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized relapse rate (ARR)', 'timeFrame': 'Up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants who did not have a confirmed relapse', 'timeFrame': 'At 12 and 24 months'}, {'measure': 'Number of gadolinium enhancing (GdE) T1 lesions', 'timeFrame': 'At month 6 and month 12'}, {'measure': 'Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences', 'timeFrame': 'At 6, 12, 18, and 24 months'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs) over the treatment period and over the post-treatment follow-up period', 'timeFrame': 'Up to 87 months'}, {'measure': 'Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period', 'timeFrame': 'Up to 87 months'}, {'measure': 'Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period', 'timeFrame': 'Up to 87 months'}, {'measure': 'Steady state plasma concentrations of ozanimod', 'timeFrame': 'At day 90'}, {'measure': 'Steady state plasma concentrations of the primary active metabolite CC112273', 'timeFrame': 'At day 90'}, {'measure': 'Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count', 'timeFrame': 'At day 90 and throughout the study up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Relapsing-Remitting', 'Ozanimod', 'Zeposia®'], 'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.\n* Meets at least 1 of the following criteria for disease activity:\n\n i) At least 1 MS relapse/attack in the previous year prior to screening.\n\nii) At least 2 MS relapses/attacks in the previous 2 years prior to screening.\n\niii) Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI).\n\n\\- Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive.\n\nExclusion Criteria:\n\n* Diagnosis of progressive forms of MS.\n* Active or chronic disease of the immune system other than MS.\n* Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.\n* Other protocol-defined Inclusion/Exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06408259', 'briefTitle': 'Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'IM047-050'}, 'secondaryIdInfos': [{'id': '2022-501332-42', 'type': 'REGISTRY', 'domain': 'EU Trial Number'}, {'id': 'U1111-1281-5433', 'type': 'REGISTRY', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ozanimod', 'interventionNames': ['Drug: Ozanimod', 'Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fingolimod', 'interventionNames': ['Drug: Fingolimod', 'Other: Placebo']}], 'interventions': [{'name': 'Ozanimod', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Ozanimod']}, {'name': 'Fingolimod', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Fingolimod']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Fingolimod', 'Ozanimod']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0114', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0114', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0130', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0130', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Natalie Moreo, Site 0053', 'role': 'CONTACT', 'phone': '813-396-9478'}], 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0093', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0055', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0055', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0047', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0047', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0131', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0131', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0132', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0091', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0092', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0092', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '79912', 'city': 'El Paso', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0133', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0133', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0033', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0033', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '3052', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Eppie Yiu, Site 0113', 'role': 'CONTACT', 'phone': '6139455661'}], 'facility': "Royal Children's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Campania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Brescia Morra, Site 0083', 'role': 'CONTACT', 'phone': '+39081743741'}], 'facility': 'University of Naples Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Filippi, Site 0082', 'role': 'CONTACT', 'phone': '+390226433958'}], 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20133', 'city': 'Milan', 'state': 'Lombardy', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Site 0081', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0081', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00178', 'city': 'Rome', 'state': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo Pozzilli, Site 0086', 'role': 'CONTACT', 'phone': '06.3377.5441'}], 'facility': 'Neurological Center Of Latium', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '04530', 'city': 'Mexico City', 'state': 'DIF', 'status': 'WITHDRAWN', 'country': 'Mexico', 'facility': 'Local Institution - 0078', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '60-355', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Barbara Steinborn, Site 0108', 'role': 'CONTACT', 'phone': '48618691255'}], 'facility': 'Uniwersytecki Szpital Kliniczny w Poznaniu', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '4710-243', 'city': 'Braga', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Joao Cerqueira, Site 0103', 'role': 'CONTACT', 'phone': '+351915301556'}], 'facility': '2Ca Braga', 'geoPoint': {'lat': 41.5514, 'lon': -8.42311}}, {'zip': '3000-602', 'city': 'Coimbra', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Filipe Palavra, Site 0105', 'role': 'CONTACT', 'phone': '+351914632128'}], 'facility': 'Unidade Local de Saúde de Coimbra, E.P.E.', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '1169-050', 'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'João Sequeira, Site 0104', 'role': 'CONTACT', 'phone': '00351912576085'}], 'facility': 'Centro Hospitalar de Lisboa Central', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4200-319', 'city': 'Porto', 'status': 'WITHDRAWN', 'country': 'Portugal', 'facility': 'Local Institution - 0102', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '022102', 'city': 'Bucharest', 'state': 'București', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Raluca Teleanu, Site 0088', 'role': 'CONTACT', 'phone': '0040722241042'}], 'facility': 'Spitalul Clinic de Copii Doctor Victor Gomoiu', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '041914', 'city': 'Bucharest', 'state': 'București', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Cristina Pomeran, Site 0087', 'role': 'CONTACT', 'phone': '0040770419542'}], 'facility': 'Prof. Dr. Alexandru Obregia Psychiatry Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '08950', 'city': 'Esplugues de Llobregat', 'state': 'Barcelona [Barcelona]', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site 0096', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0096', 'geoPoint': {'lat': 41.37732, 'lon': 2.08809}}, {'zip': '36203', 'city': 'Vigo', 'state': 'Pontevedra [Pontevedra]', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Elena Rodriguez, Site 0098', 'role': 'CONTACT', 'phone': '+34986217300'}], 'facility': 'CHUVI- Hospital Alvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '41009', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'SARA EICHAU MADUEÑO, Site 0099', 'role': 'CONTACT', 'phone': '0034955006627'}], 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46026', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Francisco Pérez-Miralles, Site 0094', 'role': 'CONTACT'}], 'facility': 'Hospital Universitari i Politecnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '50009', 'city': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jesus Martin Martinez, Site 0101', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '10002', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wang-Tso Lee, Site 0115', 'role': 'CONTACT', 'phone': '0972651495'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '55270', 'city': 'Samsun', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'murat terzi, Site 0109', 'role': 'CONTACT', 'phone': '+905323156884'}], 'facility': 'Ondokuz Mayıs Universitesi', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'centralContacts': [{'name': 'BMS Study Connect Contact Center www.BMSStudyConnect.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '855-907-3286'}, {'name': 'First line of the email MUST contain 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.\n\nAdditional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:\n\nhttps://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html", 'accessCriteria': 'See Plan Description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}