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

Launched by BRISTOL-MYERS SQUIBB · Jul 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called ozanimod in pregnant women who have ulcerative colitis, a condition that causes inflammation in the intestines. The goal is to understand how taking ozanimod during pregnancy might affect the health of the mother, the unborn baby, and the baby after birth. This information is important to ensure the safety of both mothers and their children when ozanimod is used during pregnancy.

To participate in the study, women must be currently pregnant or have recently been pregnant and have a diagnosis of ulcerative colitis. They should live in a country where ozanimod is approved for use in treating this condition. However, women who have used other similar medications during their pregnancy are not eligible to join the trial. Once enrolled, participants can expect to be monitored throughout their pregnancy and after giving birth to gather valuable information on the outcomes for both them and their babies. This study is designed to help improve care for other pregnant women with ulcerative colitis in the future.

Gender

FEMALE

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.