Safety of Abrocitinib in Pregnant Women and Their Babies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety of abrocitinib (CIBINQO) in pregnant women and their offspring. It will compare two groups: pregnant women who have received abrocitinib during pregnancy and those with moderate-to-severe atopic dermatitis who have not been exposed to the drug. Participants will be monitored until their infants reach 12 months of age to gather data on any potential safety concerns. The study will help determine the implications of using abrocitinib during pregnancy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pfizer
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.