A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
1 other identifier
observational
1,182
2 countries
3
Brief Summary
The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2021
CompletedFirst Posted
Study publicly available on registry
December 27, 2021
CompletedStudy Start
First participant enrolled
July 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2032
November 20, 2025
November 1, 2025
10 years
December 22, 2021
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major congenital malformations
Up to first year of life
Secondary Outcomes (14)
Minor congenital malformations
Up to first year of life
Pre-eclampsia
Through pregnancy
Eclampsia
Through pregnancy
Spontaneous abortion
Through pregnancy
Stillbirth
Through pregnancy
- +9 more secondary outcomes
Study Arms (3)
Ozanimod-exposed participants
Women with a diagnosis of multiple sclerosis (MS) who are exposed to ozanimod during the exposure window.
Comparator-exposed participants
Women with a diagnosis of MS who are not exposed to ozanimod or other sphingosine 1-phosphate (S1P) therapies during the exposure window but who are exposed to other products approved to treat MS during the exposure window.
Unexposed participants
Women with a diagnosis of MS who are not exposed to ozanimod or other products approved to treat MS during the exposure window.
Eligibility Criteria
The study population will include pregnant women of any age who reside in the United States, Canada or Germany.
You may qualify if:
- Diagnosis of Multiple sclerosis (MS)
- Currently or recently pregnant
- Reside in the United States, Canada or Germany.
You may not qualify if:
- Exposure to other S1P therapies, cladribine, or mitoxantrone during the first trimester.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Evidera INC.
Bethesda, Maryland, 20814, United States
Evidera
Bethesda, Maryland, 20814, United States
Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum
Herne, 44625, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
First line of the email MUST contain the NCT# and Site #.
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2021
First Posted
December 27, 2021
Study Start
July 15, 2022
Primary Completion (Estimated)
June 30, 2032
Study Completion (Estimated)
June 30, 2032
Last Updated
November 20, 2025
Record last verified: 2025-11