[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05953402":3,"trial-entities:NCT05953402":117,"trial-summary:NCT05953402":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":27,"primary_purpose":15,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":33,"secondary_outcomes":37,"sex":69,"minimum_age":15,"maximum_age":15,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":79,"locations":83,"central_contacts":97,"overall_officials":104,"references":107,"see_also_links":108},"NCT05953402","IM047-026","A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring","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","RECRUITING","2034-06-30","2026-06","2026-06-15","2026-04-21","Bristol-Myers Squibb","INDUSTRY",null,"The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.",[18],"Ulcerative Colitis",[20,21,22,23,24,25,18,26],"ZEPOSIA®","Ozanimod","Pregnancy","Sphingosine-1-phosphate (S1P) therapies","Inflammatory Bowel Disease","IBD","UC","OBSERVATIONAL",[],{"count":30,"type":31},1182,"ESTIMATED",[],[34],{"measure":35,"timeFrame":36},"Event rate of Major Congenital Malformations (MCM)","Up to 12 months",[38,40,43,45,47,49,51,53,55,57,59,62,65,67],{"measure":39,"timeFrame":36},"Event rate of minor congenital malformations",{"measure":41,"timeFrame":42},"Event rate of pre-eclampsia","Up to 9 months",{"measure":44,"timeFrame":42},"Event rate of eclampsia",{"measure":46,"timeFrame":42},"Event rate of Spontaneous Abortion (SAB)",{"measure":48,"timeFrame":42},"Event rate of stillbirth",{"measure":50,"timeFrame":42},"Event rate of elective termination",{"measure":52,"timeFrame":42},"Event rate of preterm birth",{"measure":54,"timeFrame":36},"Event rate of Small for Gestational Age (SGA)",{"measure":56,"timeFrame":36},"Event rate of postnatal growth deficiency",{"measure":58,"timeFrame":36},"Event rate of infant developmental deficiency",{"measure":60,"timeFrame":61},"Event rate of perinatal death","Up to 10 months",{"measure":63,"timeFrame":64},"Event rate of neonatal death","Up to 1 month",{"measure":66,"timeFrame":36},"Event rate of infant death",{"measure":68,"timeFrame":36},"Event rate of serious or opportunistic infant infections","FEMALE",false,{"inclusion":72,"exclusion":76,"raw_text":78},[73,74,75],"Currently or recently pregnant","Diagnosis of UC","Resident of country where ozanimod is prescribed for the treatment of UC",[77],"Exposure to other S1P therapies at any time during pregnancy","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.",[80,81,82],"CHILD","ADULT","OLDER_ADULT",[84],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":94},"PPD Virtual - PPD - US","Wilmington","North Carolina","28401-3331","United States",[91],{"name":92,"role":93},"Site 0001","CONTACT",{"lat":95,"lon":96},34.23556,-77.94604,[98,102],{"name":99,"role":93,"phone":100,"email":101},"BMS Study Connect Contact Center www.BMSStudyConnect.com","855-907-3286","Clinical.Trials@bms.com",{"name":103,"role":93},"First line of the email MUST contain the NCT# and Site #.",[105],{"name":13,"affiliation":13,"role":106},"STUDY_DIRECTOR",[],[109,112,114],{"label":110,"url":111},"BMS Clinical Trial Information","https:\u002F\u002Fwww.bms.com\u002Fresearchers-and-partners\u002Fclinical-trials-and-research.html",{"label":113,"url":111},"Investigator Inquiry Form",{"label":115,"url":116},"FDA Safety Alerts and Recalls","https:\u002F\u002Fwww.fda.gov\u002FSafety\u002FMedWatch\u002FSafetyInformation\u002Fdefault.htm",{"nct_id":4,"conditions":118,"biomarkers":119},[18],[],{"nct_id":4,"found":70,"summary":15,"prompt_version":15}]