Actively Recruiting
A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring
Led by Pfizer · Updated on 2025-12-09
400
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
Sponsors
P
Pfizer
Lead Sponsor
P
PPD Development, LP
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women of any age who are currently pregnant or have been pregnant within the past year
- Consent to participate with a signed and dated informed consent document
- Authorization for healthcare provider(s) to provide data to the registry
- Received at least one dose of CIBINQO during pregnancy or within one day before conception, OR diagnosed with moderate-to-severe atopic dermatitis before pregnancy outcome
You will not qualify if you...
- Not meeting all the inclusion criteria listed above
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pfizer
New York, New York, United States, 10001
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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