Status: Planned First registered on: 18/04/2023
Last updated on: 15/05/2023
1. Study identification
EU PAS Register NumberEUPAS104085
Official titlePost-authorisation Safety Study of Tralokinumab Use in Pregnancy: An Observational Study Based on Electronic Healthcare Data
Study title acronym
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?Yes: EMA, United States
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Rivero
First name Elena
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

BIPS GmbH
RTI-HS
Bordeaux PharmacoEpi
Carelon Research, Delaware, United States
Countries in which this study is being conducted
International study

France
Germany
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/07/202127/07/2021
Start date of data collection01/10/2026
Start date of data analysis08/01/2027
Date of interim report, if expected30/06/2027
Date of final study report31/12/2030
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesLeo Pharma A/S100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Rivero
First name Elena
Address line 1Av. Diagonal, 605, 9-1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain
Phone number (incl. country code)34933622802 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address erivero@rti.org
Public Enquiries
Title Dr 
Last name Rivero 
First name Elena 
Address line 1Av. Diagonal, 605, 9-1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain 
Phone number (incl. country code)34933622802 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address erivero@rti.org 
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