NCT06133049

A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants

Zeposia (Ozanimod) Pregnancy Study: A Retrospective Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,961 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with multiple sclerosis (MS) who were exposed to ozanimod during pregnancy; the second is women with MS exposed to select other disease-modifying therapies (DMTs) during pregnancy; the third is women with MS not exposed to any DMTs during pregnancy. This study will use data from a large US healthcare claims database.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Ozanimod	Women with MS who were exposed to ozanimod during pregnancy
DRUG	Select DMTs other than ozanimod	Women with MS exposed to select DMTs other than ozanimod during pregnancy
DRUG	No DMTs	Women with MS not exposed to any DMTs during pregnancy

Timeline

• Start date: 2021-03-16
• Primary completion: 2031-03-31
• Completion: 2031-08-31
• First posted: 2023-11-15
• Last updated: 2023-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study