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

NCT05938478 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2025-01-28

No results posted yet for this study

Summary

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

Interventions

DRUG

Tralokinumab

This is a prospective observational cohort study. There is no treatment allocation. Participants that have been exposed to tralokinumab before enrollment into the study will be enrolled.

Sponsors & Collaborators

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2034-11-30
Completion
2035-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05938478 on ClinicalTrials.gov