Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05953402

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

The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

Female

Study type

Observational

Primary location

PPD Virtual - PPD - US

Wilmington, North Carolina, 28401-3331, United States

Location status: Recruiting

Location contact

Site 0001

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently or recently pregnant
  • Diagnosis of UC
  • Resident of country where ozanimod is prescribed for the treatment of UC

Exclusion criteria

  • Exposure to other S1P therapies at any time during pregnancy

Other protocol-defined eligibility criteria apply.

Treatment and study plan

Primary outcomes

  1. Event rate of Major Congenital Malformations (MCM)

    Time frame: Up to 12 months

Secondary outcomes

  1. Event rate of minor congenital malformations

    Time frame: Up to 12 months

  2. Event rate of pre-eclampsia

    Time frame: Up to 9 months

  3. Event rate of eclampsia

    Time frame: Up to 9 months

  4. Event rate of Spontaneous Abortion (SAB)

    Time frame: Up to 9 months

  5. Event rate of stillbirth

    Time frame: Up to 9 months

  6. Event rate of elective termination

    Time frame: Up to 9 months

  7. Event rate of preterm birth

    Time frame: Up to 9 months

  8. Event rate of Small for Gestational Age (SGA)

    Time frame: Up to 12 months

  9. Event rate of postnatal growth deficiency

    Time frame: Up to 12 months

  10. Event rate of infant developmental deficiency

    Time frame: Up to 12 months

  11. Event rate of perinatal death

    Time frame: Up to 10 months

  12. Event rate of neonatal death

    Time frame: Up to 1 month

  13. Event rate of infant death

    Time frame: Up to 12 months

  14. Event rate of serious or opportunistic infant infections

    Time frame: Up to 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain the NCT# and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

ZEPOSIA® (Ozanimod) Ulcerative Colitis Pregnancy Registry: a Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women With Ulcerative Colitis and Their Offspring

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Jul 20, 2023
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.