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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether taking ozanimod during pregnancy is linked to health outcomes for mothers and their babies. It is for women who are pregnant or were recently pregnant and have ulcerative colitis (UC), a disease that causes swelling and sores in the large intestine.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are pregnant now or were recently pregnant.
  • Have ulcerative colitis (UC).
  • Live in a country where ozanimod is prescribed to treat UC.
  • Other study rules also apply.

Who can't join

  • Used another S1P therapy (a medicine in the same group as ozanimod) at any time during pregnancy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

NC