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

Bristol-Myers Squibb (BMS)

Status: Enrolling

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT05170126

IM047-003

Details and patient eligibility

About

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.

Enrollment: 1,182 estimated patients

Sex: Female

Volunteers: No 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

Trial design

1,182 participants in 3 patient groups

Ozanimod-exposed participants

Description:

Women with a diagnosis of multiple sclerosis (MS) who are exposed to ozanimod during the exposure window.

Comparator-exposed participants

Description:

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

Description:

Women with a diagnosis of MS who are not exposed to ozanimod or other products approved to treat MS during the exposure window.