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

Part of paid clinical trials in New York, New York.

Sponsor
Pfizer
Study ID
NCT05721937
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
0 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Abrocitinib — DRUG
    taken by mouth

Study Details

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.

Key Dates

Start date
Jul 25, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: 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).
  • Arm: Unexposed to CIBINQO during pregnancy
    Diagnosed with moderate-to-severe atopic dermatitis, but not exposed to CIBINQO during pregnancy.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PfizerNew YorkNew York10001-

Find similar trials in New York, NY

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Pfizer· New York, NY

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