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

Bristol-Myers Squibb (BMS)

Status: Not yet enrolling

Conditions: Ulcerative Colitis

Study type: Observational

Funder types: Industry

Identifiers

NCT05953402

IM047-026

Details and patient eligibility

About

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

Enrollment: 1,182 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

1,182 participants in 3 patient groups

Ozanimod-exposed participants with UC

Description:

Pregnant women with a diagnosis of UC who are exposed to ozanimod at any time during pregnancy

Conventional therapy-exposed participants with UC

Description:

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

Advanced therapy-exposed participants with UC

Description:

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