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Clinical Trials in the USA / NCT05170126
Recruiting Observational

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

NCT05170126 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Observational
Started
2022-07-15
Last updated
2025-11-20

Condition(s) studied

Multiple Sclerosis

Study 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.

Eligibility

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Major congenital malformations — Up to first year of life

Trial sites (3)

FacilityCityRegionStatus
Evidera INC. Bethesda Maryland Recruiting
Evidera Bethesda Maryland Recruiting
Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum Herne Germany Recruiting

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A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants Active, not recruiting
A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors Recruiting
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Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) Recruiting

Other trials for the same condition

Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis Recruiting
Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent Recruiting
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis Recruiting
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis Active, not recruiting
A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05170126 on ClinicalTrials.gov ↗ ← All trials in the USA