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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721937
• Other study ID #: B7451095
• Status: Recruiting
• Start date: July 25, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: August 2023
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 0 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis

Intervention

Drug:
• Abrocitinib
taken by mouth

Locations

Country	Name	City	State
United States	Pfizer	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	PPD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of live birth children with major congenital malformations	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.	Enrollment until 12 months after delivery
Secondary	Percent of participants with children with minor congenital malformations	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.	Enrollment until 12 months after delivery
Secondary	Percent of participants with spontaneous abortion	An involuntary fetal loss or the expulsion of the products of conception occurring at <20 gestational weeks.	Enrollment until end of pregnancy (up to 20 gestational weeks)
Secondary	Percent of participants with stillbirths	An involuntary fetal loss occurring at =20 gestational weeks or, if gestational age is unknown, a fetus weighing =350 g.	Enrollment until end of pregnancy (up to 9 months)
Secondary	Percentage of participants with an elective termination	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	Enrollment until end of pregnancy (up to 9 months)
Secondary	Percent of participants with preterm birth	A live birth occurring at <37 gestational weeks.	Enrollment until 12 months after delivery
Secondary	Percent of participants with children born small for gestational age	Birthweight <10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.	Enrollment until 12 months after delivery
Secondary	Percentage of participants with children with postnatal growth deficiency	Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts	Enrollment until 12 months after delivery
Secondary	Percent of participants with infant developmental delay	Failure to achieve the developmental milestones for chronological age, as defined by the CDC.	Enrollment until 12 months after delivery

External Links

•   Link to CIBINQO Pregnancy Registry Website
•   To obtain contact information for a study center near you, click here.