RecruitingNCT05721937

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


Sponsor

Pfizer

Enrollment

400 participants

Start Date

Jul 25, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 0 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Abrocitinib for people with atopic dermatitis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbrocitinib

taken by mouth


Locations(1)

Pfizer

New York, New York, United States

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NCT05721937


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