NCT06126835

A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants

Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,828 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Ozanimod	Women with UC exposed to ozanimod during pregnancy
DRUG	Conventional therapy	Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy
DRUG	Advanced therapy	Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy

Timeline

• Start date: 2024-08-26
• Primary completion: 2031-05-31
• Completion: 2032-06-30
• First posted: 2023-11-13
• Last updated: 2024-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study