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

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)

Facility	City	Region	Status
Evidera INC.	Bethesda	Maryland	Recruiting
Evidera	Bethesda	Maryland	Recruiting
Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum	Herne	Germany	Recruiting

More Bristol-Myers Squibb trials in the USA

Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU) Recruiting

Real-world Patient Characteristics, Treatment Patterns, and Healthcare Utilization Among KarXT Users Active, not recruiting

A Study to Evaluate the Drug Levels, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 in Healthy Adults After Single-dose Administration, and Participants With Early Alzheimer's Disease After Multiple Dose Administration Starting soon

An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis Active, not recruiting

Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Recruiting

Other trials for the same condition

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis Active, not recruiting

A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis Active, not recruiting

KYSA-7: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis Active, not recruiting

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis Active, not recruiting

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS) 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