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Study identifier: NCT05938478 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT

Condition: Atopic Dermatitis · Eczema  ·  Sponsor: University of California, San Diego

PhaseN/A
Planned participants900
Who can joinFemale, N/A to no upper limit
Healthy volunteersNo

About this study

The goal of this observational study is to learn about exposure to tralokinumab during pregnancy, as well as atopic dermatitis (AD) during pregnancy. The main question the study aims to answer is whether pregnant people who have been exposed to tralokinumab during pregnancy experience any differences in pregnancy and infant outcomes compared to women with atopic dermatitis who have not been exposed to tralokinumab during pregnancy. Participants are not required to take tralokinumab during the study. Participants will be asked to: * Complete 1-3 phone interviews during pregnancy and 1-2 phone interviews after delivery * Release medical records for pregnancy and for their child * Complete an online survey about their baby's development at 4 months and 12 months of age * May be asked to have a study doctor examine their child All information is collected remotely, and no visits to the study site are required.

This description comes directly from the study's public registry record.

Talk to the study team

Diana Johnson, MS  ·  877-311-8972  ·  mothertobaby@health.ucsd.edu

Always discuss trial participation with your own doctor first.

Locations (1)

University of California San Diego (UCSD)La Jolla, California, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05938478