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NCT Number: NCT05721937

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

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.

Recruiting

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

0 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Pfizer

New York, 10001, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abrocitinib

Drug

taken by mouth

Primary outcomes

  1. Percent of live birth children with major congenital malformations

    Time frame: Enrollment 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.

Secondary outcomes

  1. Percent of participants with children with minor congenital malformations

    Time frame: Enrollment until 12 months after delivery

    An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual.

  2. Percent of participants with spontaneous abortion

    Time frame: Enrollment until end of pregnancy (up to 20 gestational weeks)

    An involuntary fetal loss or the expulsion of the products of conception occurring at <20 gestational weeks.

  3. Percent of participants with stillbirths

    Time frame: Enrollment until end of pregnancy (up to 9 months)

    An involuntary fetal loss occurring at ≥20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥350 g.

  4. Percentage of participants with an elective termination

    Time frame: Enrollment until end of pregnancy (up to 9 months)

    A voluntary fetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or due to fetal abnormalities

  5. Percent of participants with preterm birth

    Time frame: Enrollment until 12 months after delivery

    A live birth occurring at <37 gestational weeks.

  6. Percent of participants with children born small for gestational age

    Time frame: Enrollment until 12 months after delivery

    Birthweight <10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.

  7. Percentage of participants with children with postnatal growth deficiency

    Time frame: Enrollment until 12 months after delivery

    Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts

  8. Percent of participants with infant developmental delay

    Time frame: Enrollment until 12 months after delivery

    Failure to achieve the developmental milestones for chronological age, as defined by the CDC.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • PPD Development, LP

Registry information

Official study title

CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2023
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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