Recruiting

Abrocitinib

Sponsor:

Pfizer

Code:

NCT05721937

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Abrocitinib

Study Details

Brief summary:

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

Atopic Dermatitis

Study ID

NCT05721937

Start date

Jul 25, 2023

Status verified date

Dec, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Exposed to CIBINQO during pregnancy

Received at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy (within 1 day prior to the date of conception).

Unexposed to CIBINQO during pregnancy

Diagnosed with moderate-to-severe atopic dermatitis, but not exposed to CIBINQO during pregnancy.

Interventions

Abrocitinib

taken by mouth

Primary outcome measure

  • Percent of live birth children with major congenital malformations [ Time Frame: Enrollment until 12 months after delivery ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Pfizer

Recruiting

New York, New York, United States, 10001

More Information

Sponsor

Pfizer

Last update posted

Dec 9, 2025

Last verified

Dec, 2025

Keywords

  • pregnancy
  • dermatitis, atopic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pfizer on 2025-12-09.