A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring

Study Overview
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Brief Summary
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The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.

Official Title
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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

Conditions
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Ulcerative Colitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently or recently pregnant Diagnosis of UC Resident of country where ozanimod is prescribed for the treatment of UC Exclusion Criteria: Exposure to other S1P therapies at any time during pregnancy Other protocol-defined eligibility criteria apply.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ozanimod-exposed participants with UC<br>Pregnant women with a diagnosis of UC who are exposed to ozanimod at any time during pregnancy | |
| Conventional therapy-exposed participants with UC<br>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 | |
| Advanced therapy-exposed participants with UC<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event rate of Major Congenital Malformations (MCM) |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event rate of minor congenital malformations |  | Up to 12 months | 
| Event rate of pre-eclampsia |  | Up to 9 months | 
| Event rate of eclampsia |  | Up to 9 months | 
| Event rate of Spontaneous Abortion (SAB) |  | Up to 9 months | 
| Event rate of stillbirth |  | Up to 9 months | 
| Event rate of elective termination |  | Up to 9 months | 
| Event rate of preterm birth |  | Up to 9 months | 
| Event rate of Small for Gestational Age (SGA) |  | Up to 12 months | 
| Event rate of postnatal growth deficiency |  | Up to 12 months | 
| Event rate of infant developmental deficiency |  | Up to 12 months | 
| Event rate of perinatal death |  | Up to 10 months | 
| Event rate of neonatal death |  | Up to 1 month | 
| Event rate of infant death |  | Up to 12 months | 
| Event rate of serious or opportunistic infant infections |  | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ZEPOSIA®, Ozanimod, Pregnancy, Sphingosine-1-phosphate (S1P) therapies, Inflammatory Bowel Disease, IBD, Ulcerative Colitis, UC