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

Recruiting now

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT05170126

Run by

Bristol-Myers Squibb

People needed

1182

Starts

2022-07-15

Expected to finish

2032-06-30

Last updated by the study team

2025-11-20

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

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.
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Evidera INC. — Bethesda, Maryland, United States (enrolling)
• Evidera — Bethesda, Maryland, United States (enrolling)
• Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum — Herne, Germany (enrolling)

Full record on ClinicalTrials.gov

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