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
First published:
01/02/2024
Institution

Networks

PPD

Contact details

Jenny Sun

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
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