Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT05953402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2023-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1182}, 'targetDuration': '21 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2033-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2023-07-12', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-06-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event rate of Major Congenital Malformations (MCM)', 'timeFrame': 'Up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Event rate of minor congenital malformations', 'timeFrame': 'Up to 12 months'}, {'measure': 'Event rate of pre-eclampsia', 'timeFrame': 'Up to 9 months'}, {'measure': 'Event rate of eclampsia', 'timeFrame': 'Up to 9 months'}, {'measure': 'Event rate of Spontaneous Abortion (SAB)', 'timeFrame': 'Up to 9 months'}, {'measure': 'Event rate of stillbirth', 'timeFrame': 'Up to 9 months'}, {'measure': 'Event rate of elective termination', 'timeFrame': 'Up to 9 months'}, {'measure': 'Event rate of preterm birth', 'timeFrame': 'Up to 9 months'}, {'measure': 'Event rate of Small for Gestational Age (SGA)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Event rate of postnatal growth deficiency', 'timeFrame': 'Up to 12 months'}, {'measure': 'Event rate of infant developmental deficiency', 'timeFrame': 'Up to 12 months'}, {'measure': 'Event rate of perinatal death', 'timeFrame': 'Up to 10 months'}, {'measure': 'Event rate of neonatal death', 'timeFrame': 'Up to 1 month'}, {'measure': 'Event rate of infant death', 'timeFrame': 'Up to 12 months'}, {'measure': 'Event rate of serious or opportunistic infant infections', 'timeFrame': 'Up to 12 months'}]}, 'conditionsModule': {'keywords': ['ZEPOSIA®', 'Ozanimod', 'Pregnancy', 'Sphingosine-1-phosphate (S1P) therapies', 'Inflammatory Bowel Disease', 'IBD', 'Ulcerative Colitis', 'UC'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include women of any age who i) are currently or recently have been pregnant; ii) have a diagnosis of UC; iii) reside in a country where ozanimod is prescribed for the treatment of UC; iv) provide consent to participate as well as medical releases for their Healthcare Providers (HCPs) to provide data to the registry; and v) meet the criteria for inclusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently or recently pregnant\n* Diagnosis of UC\n* Resident of country where ozanimod is prescribed for the treatment of UC\n\nExclusion Criteria:\n\n* Exposure to other S1P therapies at any time during pregnancy\n\nOther protocol-defined eligibility criteria apply.'}, 'identificationModule': {'nctId': 'NCT05953402', 'briefTitle': 'A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'ZEPOSIA® (Ozanimod) Ulcerative Colitis Pregnancy Registry: a Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women With Ulcerative Colitis and Their Offspring', 'orgStudyIdInfo': {'id': 'IM047-026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ozanimod-exposed participants with UC', 'description': 'Pregnant women with a diagnosis of UC who are exposed to ozanimod at any time during pregnancy'}, {'label': 'Conventional therapy-exposed participants with UC', 'description': 'Pregnant women with a diagnosis of UC who are exposed to conventional therapies (aminosalicylates and/or thiopurines) but not exposed to ozanimod, other S1P therapies, or advanced therapies for UC (biologics and/or small molecules) at any time during pregnancy'}, {'label': 'Advanced therapy-exposed participants with UC', 'description': 'Pregnant women with a diagnosis of UC who are exposed to advanced therapies for UC (biologics and/or small molecules) but not exposed to ozanimod or other S1P therapies at any time during pregnancy'}]}, 'contactsLocationsModule': {'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 the NCT# and Site #.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}