Study identification

EU PAS number

EUPAS104085

Study ID

104924

Official title and acronym

Post-authorisation Safety Study of Tralokinumab Use in Pregnancy: An Observational Study Based on Electronic Healthcare Data

DARWIN EU® study

No

Study countries

France
Germany
United States

Study description

This study will investigate whether maternal exposure to tralokinumab during pregnancy is associated with increased risk of adverse pregnancy and infant outcomes: major congenital malformations, infants born small for gestational age, preterm births, spontaneous abortions, or stillbirths. This is an observational cohort study using prospectively collected secondary health care data from 1 US and 2 European data sources. Three study groups will be included: 1) a tralokinumab-exposed group of pregnant women with atopic dermatitis (AD) treated with tralokinumab, 2) a primary comparator group of pregnant women with AD exposed to other, non-tralokinumab, systemic treatments for AD, and 3) a secondary comparator group of pregnant women with AD unexposed to tralokinumab or other systemic therapies for AD.

Study status

Planned
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner
Carelon Research, Delaware, United States

Contact details

Elena Rivero

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Leo Pharma A/S
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)