Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
Eligible age
All ages
Accepts
Women
Locations
1 state
Healthy volunteers
No
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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.
Sponsor: University of California, San Diego
You may qualify if…
- ✓ Eligibility for the cohort study includes the following:
- ✓ 1. Currently pregnant at the time of enrollment
- ✓ 2. Reside in the US or Canada at the time of enrollment
- ✓ 3. Verbal informed consent to participate OTIS Pregnancy Registry
- ✓ 4. Current diagnosis of AD at the time of enrollment
- ✓ Cohort 1: Tralokinumab-Exposed Cohort
- ✓ 1. Diagnosed with AD
- ✓ 2. Exposure to tralokinumab for any number of days, at any dose, and at any time during pregnancy or within 16 weeks prior to the date of conception
You may not qualify if…
- ✕ Pregnant women meeting any of the following criteria will not be included in the cohort study:
- ✕ Cohort 1: Tralokinumab-Exposed Cohort
- ✕ 1. Women who have enrolled in the tralokinumab cohort study with a previous pregnancy
- ✕ 2. Exposure to any dose of methotrexate or mycophenolate mofetil within 5 half-lives prior to the estimated date of conception or anytime during pregnancy
- ✕ 3. Retrospective enrollment after the outcome of pregnancy is known (i.e., the pregnancy has ended prior to enrollment)
- ✕ 4. Results of a diagnostic test are positive for a major structural birth defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect
- ✕ Cohort 2: AD Therapy Comparator I- Phototherapy or Systemic Treatment
- ✕ 1. Pregnant women who have enrolled in the tralokinumab cohort study with a previous pregnancy
Where it's recruiting
La Jolla
Source: ClinicalTrials.gov · NCT05938478 · last updated 2025-01-28