NCT05721937

A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring

CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 0 Years
• Healthy volunteers: Accepted

Summary

The purpose of this observational study is to learn about the safety of abrocitinib (CIBINQO) in pregnant women and the offspring. The study is seeking participants who: * Are currently or recently pregnant * Receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy OR have a diagnosis of moderate-to-severe atopic dermatitis All participants in this study will receive treatment according to routine care, as this is an observational study. The exposed group will consist of pregnant women exposed to abrocitinib during pregnancy. The unexposed group will consistent of pregnant women with moderate-to-severe atopic dermatitis who are not exposed to abrocitinib during pregnancy. The study will compare the experiences of pregnant women receiving abrocitinib to pregnant women who do not. This will help us determine if abrocitinib is safe during pregnancy. Participants will take part in this study until their infant is 12 months of age. During this time, the participant's care will be managed no differently than if she was not taking part in this study. Data will be collected through a virtual research coordinating center at enrollment, the end of the second trimester, and pregnancy outcome (live birth or fetal loss). For live-born infants, data on the infants will be collected at 4 and 12 months of age. No additional visits beyond routine care will be required.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Abrocitinib	taken by mouth

Timeline

• Start date: 2023-07-25
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2023-02-10
• Last updated: 2025-12-09

Locations

1 site across 1 country: United States