Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05170126

A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum, Herne, Germany

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Multiple sclerosis (MS)
  • Currently or recently pregnant
  • Reside in the United States, Canada or Germany.

Exclusion criteria

  • Exposure to other S1P therapies, cladribine, or mitoxantrone during the first trimester.

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

Primary outcomes

  1. Major congenital malformations

    Time frame: Up to first year of life

Secondary outcomes

  1. Minor congenital malformations

    Time frame: Up to first year of life

  2. Pre-eclampsia

    Time frame: Through pregnancy

  3. Eclampsia

    Time frame: Through pregnancy

  4. Spontaneous abortion

    Time frame: Through pregnancy

  5. Stillbirth

    Time frame: Through pregnancy

  6. Elective termination

    Time frame: Through pregnancy

  7. Preterm birth

    Time frame: Through pregnancy

  8. Small for gestational age

    Time frame: Up to first year of life

  9. Postnatal growth deficiency

    Time frame: Up to first year of life

  10. Infant developmental deficiency

    Time frame: Up to first year of life

  11. Perinatal death

    Time frame: Up to first year of life

  12. Neonatal death

    Time frame: Up to first year of life

  13. Infant death

    Time frame: Up to first year of life

  14. Serious or opportunistic infant infection (SOI)

    Time frame: Up to first year of life

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain the NCT# and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Dec 27, 2021
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.