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

Pfizer

Status: Enrolling

Conditions: Atopic Dermatitis

Treatments: Drug: Abrocitinib

Study type: Observational

Funder types: Industry

Identifiers

NCT05721937

NCT05721937 (Registry Identifier)

B7451095

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women of any age who are currently or recently pregnant (recently pregnant defined as enrollment within 1 year of pregnancy outcome)
• Consent to participate in this study and evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) 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 to pregnancy (within 1 day prior to the date of conception) OR have a diagnosis of moderate-to-severe atopic dermatitis at any time prior to pregnancy outcome.

Exclusion criteria

• Participants will be excluded from the registry if they do not meet the inclusion criteria listed above.

Trial design

400 participants in 2 patient groups

Exposed to CIBINQO during pregnancy

Description:

Received at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy (within 1 day prior to the date of conception).

Treatment:

Drug: Abrocitinib

Unexposed to CIBINQO during pregnancy

Description:

Diagnosed with moderate-to-severe atopic dermatitis, but not exposed to CIBINQO during pregnancy.