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

Launched by PFIZER · Feb 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called abrocitinib (CIBINQO) for pregnant women who have a skin condition known as moderate-to-severe atopic dermatitis. The researchers want to find out if taking this medication during pregnancy is safe for both the mothers and their babies. They are looking for women who are currently pregnant or who have recently been pregnant and have either taken CIBINQO or have been diagnosed with atopic dermatitis.

If you choose to participate, you will continue to receive your usual prenatal care without any extra visits required. The study will follow you and your baby until your child is 12 months old, collecting information at specific times during your pregnancy and after the baby is born. All the data will help determine if abrocitinib is safe for use during pregnancy, which is important for future patients and their families.

Gender

FEMALE

Eligibility criteria

• 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.