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

CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure 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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Abrocitinib

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Recruiting
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will include pregnant women of any age who meet the eligibility criteria for inclusion. The exposed cohort will include women who are exposed to CIBINQO at any time during pregnancy. All pregnant women exposed to CIBINQO will be eligible to participate in the registry, but the analysis population will be limited to women with moderate-to-severe AD. The primary comparator group will include women with moderate to- severe AD who are unexposed to CIBINQO during pregnancy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Drug: Abrocitinib; taken by mouth
Unexposed to CIBINQO during pregnancy; Diagnosed with moderate-to-severe atopic dermatitis, but not exposed to CIBINQO during pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)
Percent of participants with preterm birth	A live birth occurring at <37 gestational weeks.	Enrollment until 12 months after delivery
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: PPD
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: pregnancy; dermatitis, atopic
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Abrocitinib
• Other Study ID Numbers: B7451095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.