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PROTECT: Monitoring Tralokinumab Exposure During Pregnancy for Atopic Dermatitis

This observational study, called PROTECT, is looking at how exposure to tralokinumab (a medication for atopic dermatitis, or eczema) during pregnancy affects both the pregnant person and their baby. Researchers want to compare pregnancy and infant outcomes in women who used tralokinumab during pregnancy with those who have atopic dermatitis but did not use tralokinumab. You don't need to take tralokinumab for this study. The main goal is to see if there are differences in major birth defects in babies up to one year old. This study is for pregnant women in the US or Canada who have atopic dermatitis.

Study design
This is an observational study involving about 900 pregnant women. It compares outcomes between those exposed to tralokinumab and those not exposed.
What's involved
You would complete 1-3 phone interviews during pregnancy and 1-2 after delivery, release medical records, and complete online surveys about your baby's development at 4 and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Your baby's health will be monitored through one year of age, with surveys at 4 and 12 months.

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NCT05938478

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

Recruiting
Not specifiedAll AgesObservational
University of California, San Diego
~900 participants
Updated 2025-01-28 on ClinicalTrials.gov
What's tested:Tralokinumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of Major Structural Birth Defects
Measured over Up to 1-year of age

Conditions

Atopic Dermatitis
Eczema

Explore related trials

Atopic Dermatitis

Where it's being run

1 sites across 1 states
California1

Who to contact

Diana Johnson, MS
[email protected]
877-311-8972
Email the study team

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What this trial measures

  • Prevalence of Major Structural Birth DefectsUp to 1-year of age

    Major structural defects is defined and classified using the US Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects. All major structural defects will be adjudicated by the co-investigator on this study.