A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring

Part of paid clinical trials in Wilmington, North Carolina.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05953402
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 evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.

Key Dates

Start date
Apr 21, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2034
Completion
Jun 30, 2034

Study Design

Enrollment
1,182 participants (estimated)

Arms

  • Arm: Ozanimod-exposed participants with UC
    Pregnant women with a diagnosis of UC who are exposed to ozanimod at any time during pregnancy
  • Arm: Conventional therapy-exposed participants with UC
    Pregnant women with a diagnosis of UC who are exposed to conventional therapies (aminosalicylates and/or thiopurines) but not exposed to ozanimod, other S1P therapies, or advanced therapies for UC (biologics and/or small molecules) at any time during pregnancy
  • Arm: Advanced therapy-exposed participants with UC
    Pregnant women with a diagnosis of UC who are exposed to advanced therapies for UC (biologics and/or small molecules) but not exposed to ozanimod or other S1P therapies at any time during pregnancy

Primary Outcome Measure

Event rate of Major Congenital Malformations (MCM) [ Time Frame: Up to 12 months ]

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 (1)

FacilityCityStateZIPSite coordinators
PPD Virtual - PPD - USWilmingtonNorth Carolina28401-3331
Site 0001

Find similar trials in Wilmington, NC

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
PPD Virtual - PPD - US· Wilmington, NC

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