MedTrace Logo

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

NCT05721937 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-12-09

No results posted yet for this study

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

Interventions

DRUG

Abrocitinib

taken by mouth

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
0 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-25
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05721937 on ClinicalTrials.gov