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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT05938478
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tralokinumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 8, 2022
Status verified
Jan 2025
Primary completion
Nov 30, 2034
Completion
Sep 30, 2035

Study Design

Enrollment
900 participants (estimated)

Arms

  • Arm: Tralokinumab-Exposed Cohort
    Pregnant women with AD exposed to tralokinumab anytime during pregnancy, or within 16 weeks before conception
  • Arm: AD Cohort- Phototherapy or Systemic Treatment Exposed
    Pregnant women with AD who have not been exposed to tralokinumab, but who have been exposed to phototherapy or systemic therapy for the treatment of AD during pregnancy
  • Arm: AD Cohort - With or Without Treatment
    Pregnant women with AD who may or may not have received treatment for AD, but who have not been exposed to any dose of tralokinumab, phototherapy or systemic therapy during pregnancy
  • Arm: Tralokinumab-Exposed Case Series
    Pregnant women with AD exposed to tralokinumab anytime during pregnancy, or within 16 weeks before conception, who don't meet the eligibility criteria for the tralokinumab-exposed cohort group

Primary Outcome Measure

Prevalence of Major Structural Birth Defects [ Time Frame: Up to 1-year of age ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San Diego (UCSD)La JollaCalifornia92093
Diana Johnson, MS
[email protected]
877-311-8972
Christina Chambers, PhD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in La Jolla, CA

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of California San Diego (UCSD)· La Jolla, CA

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