A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
NCT ID: NCT05953402
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1182 participants
OBSERVATIONAL
2025-12-03
2033-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ozanimod-exposed participants with UC
Pregnant women with a diagnosis of UC who are exposed to ozanimod at any time during pregnancy
No interventions assigned to this group
Conventional therapy-exposed participants with UC
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
No interventions assigned to this group
Advanced therapy-exposed participants with UC
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of UC
* Resident of country where ozanimod is prescribed for the treatment of UC
Exclusion Criteria
Other protocol-defined eligibility criteria apply.
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Related Links
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BMS Clinical Trial Information
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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IM047-026
Identifier Type: -
Identifier Source: org_study_id
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