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

Study identification

• EU PAS number:
  EUPAS50473
• Study ID:
  50474
• Official title and acronym:
  CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The CIBINQO™ Pregnancy Registry is a US-based, non-interventional, primary data collection cohort study designed to evaluate the association between CIBINQO exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. This registry will enroll pregnant patients of any age who are exposed to CIBINQO during pregnancy and/or have a diagnosis of moderate-to-severe atopic dermatitis. The outcomes of interest are major congenital malformations, minor congenital malformations, spontaneous abortions, stillbirth, elective termination, small for gestational age, preterm birth, postnatal growth deficiency, and infant developmental delay.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Networks

PPD

Study timelines

Date when funding contract was signed

Planned: 12/04/2022

Actual: 12/04/2022

Study start date

Planned: 31/01/2023

Date of final study report

Planned: 31/12/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable