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

Phase

N/A

Condition

Dermatitis, Atopic

Eczema (Atopic Dermatitis)

Atopic Dermatitis

Treatment

Abrocitinib

Clinical Study ID

NCT05721937

B7451095

Female
Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

Women of any age who are currently or recently pregnant (recently pregnant definedas enrollment within 1 year of pregnancy outcome)
Consent to participate in this study and evidence of a personally signed and datedinformed consent document indicating that the patient (or a legally acceptablerepresentative) has been informed of all pertinent aspects of the study
Authorization for her healthcare provider(s) to provide data to the registry
Must receive at least one dose of CIBINQO at any time during pregnancy or prior topregnancy (within 1 day prior to the date of conception) OR have a diagnosis ofmoderate-to-severe atopic dermatitis at any time prior to pregnancy outcome.

Exclusion

Exclusion Criteria:

Participants will be excluded from the registry if they do not meet the inclusioncriteria listed above.

Study Design