Recruiting

Ozanimod

Sponsor:

Bristol-Myers Squibb

Code:

NCT05170126

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Multiple Sclerosis

Study ID

NCT05170126

Start date

Jul 15, 2022

Status verified date

Nov, 2025

Completion date

Jun 30, 2032

Anticipated

Primary completion date

Jun 30, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1182 participants

Anticipated

Interventions and Outcome Measures

Arms

Ozanimod-exposed participants

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

Comparator-exposed participants

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

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

Primary outcome measure

  • Major congenital malformations [ Time Frame: Up to first year of life ]

Central Contacts and Locations

Central contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

855-907-3286Clinical.Trials@bms.com

Locations

Evidera INC.

Recruiting

Bethesda, Maryland, United States, 20814

Evidera

Recruiting

Bethesda, Maryland, United States, 20814

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Keywords

  • Multiple Sclerosis
  • Ozanimod
  • Pregnancy
  • Outcomes
  • Obstetric
  • Infant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2025-11-20.