Abrocitinib for Atopic Dermatitis in Pregnant Women
A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring
Recruiting
Observational Study
Atopic Dermatitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
0 and older
Sex
Female
Study type
Observational
Participants needed
400 (estimated)
Sponsor
Pfizer · Industry
Who this trial is looking for
This trial is looking for pregnant women or those who were pregnant recently. Participants will be observed to see how safe the medication abrocitinib is during pregnancy.
Are You a Good Fit for This Trial?
You may be able to join if
I am currently or recently pregnant.
I have received at least one dose of abrocitinib during or before my pregnancy.
I have moderate-to-severe atopic dermatitis at any time before my pregnancy outcome.
I consent to participate in this study.
I have signed and dated a consent document.
I authorize my healthcare provider(s) to share my data.
You may not be able to join if
I do not meet the inclusion criteria listed above.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 rece…
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.
Trial Locations
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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…
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.
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