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A Study of Abrocitinib (CIBINQO) Safety in Pregnant Women and Their Babies

This study is looking at how safe abrocitinib (CIBINQO) is for pregnant women and their babies. Abrocitinib is a medication taken by mouth for atopic dermatitis (eczema). Researchers want to see if babies born to mothers who took abrocitinib during pregnancy have any major birth defects. You can join if you are currently or recently pregnant and either took abrocitinib during or before pregnancy, or have moderate-to-severe atopic dermatitis. This is an observational study, meaning you will receive your usual medical care. The study aims to enroll 400 participants.

Study design
This is an observational study aiming to enroll 400 participants. It compares pregnant women who took abrocitinib with pregnant women who have atopic dermatitis but did not take abrocitinib.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Children will be followed from enrollment until 12 months after delivery to check for major birth defects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05721937

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

Recruiting
Not specifiedAges 0+Observational
Pfizer
~400 participants
Updated 2025-12-09 on ClinicalTrials.gov
What's tested:Abrocitinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of live birth children with major congenital malformations
Measured over Enrollment until 12 months after delivery

Conditions

Atopic Dermatitis

Explore related trials

Atopic DermatitisPregnancy

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Percent of live birth children with major congenital malformationsEnrollment until 12 months after delivery

    An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.