Actively Recruiting
Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
Led by University of California, San Diego · Updated on 2025-01-28
900
Participants Needed
1
Research Sites
668 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
L
LEO Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently pregnant at the time of enrollment
- Reside in the US or Canada at the time of enrollment
- Provide verbal informed consent to participate
- Have a current diagnosis of atopic dermatitis at enrollment
- For Tralokinumab-Exposed Cohort: diagnosed with AD and exposed to tralokinumab anytime during pregnancy or within 16 weeks before conception
- Agree to study requirements including interviews, medical record release, developmental screening, and possible child examination
- For Comparator I Cohort: diagnosed with AD and exposed to phototherapy or systemic treatment within 5 half-lives before conception or during pregnancy
- For Comparator II Cohort: diagnosed with AD and not exposed to phototherapy or systemic treatment within 5 half-lives before conception or during pregnancy
- Agree to study conditions and requirements as above
You will not qualify if you...
- For Tralokinumab-Exposed Cohort: previous pregnancy enrolled in the cohort
- Exposure to methotrexate or mycophenolate mofetil within 5 half-lives before conception or during pregnancy
- Retrospective enrollment after pregnancy outcome is known
- Positive diagnostic test result for major structural birth defect before enrollment
- For Comparator I Cohort: previous pregnancy enrolled in tralokinumab cohort
- Exposure to tralokinumab, methotrexate, or mycophenolate mofetil within 5 half-lives before conception or during pregnancy
- Retrospective enrollment after pregnancy outcome is known
- Positive diagnostic test for major structural defect prior to enrollment
- For Comparator II Cohort: previous pregnancy enrolled in tralokinumab cohort
- Exposure to tralokinumab, methotrexate, mycophenolate mofetil, phototherapy, or systemic therapy within 5 half-lives before conception or during pregnancy
- Retrospective enrollment after pregnancy outcome is known
- Positive diagnostic test for major structural defect prior to enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California San Diego (UCSD)
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
D
Diana Johnson, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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