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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05170126
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Jul 15, 2022
Status verified
Nov 2025
Primary completion
Jun 30, 2032
Completion
Jun 30, 2032

Study Design

Enrollment
1,182 participants (estimated)

Arms

  • Arm: Ozanimod-exposed participants
    Women with a diagnosis of multiple sclerosis (MS) who are exposed to ozanimod during the exposure window.
  • Arm: 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.
  • Arm: 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

  • BMS Study Connect Contact Center www.BMSStudyConnect.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain the NCT# and Site #.

Locations (2)

FacilityCityStateZIPSite coordinators
EvideraBethesdaMaryland20814
Marielle Bassel, Site 0001
Evidera INC.BethesdaMaryland20814
Marielle Bassel, Site 0003

Find similar trials in Bethesda, MD

By condition
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By specialty
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By research site
Evidera· Bethesda, MDEvidera INC.· Bethesda, MD

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