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Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
NCT05938478 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Tralokinumab
Study Locations (1)
California
- University of California San Diego (UCSD) — La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2022-12-08 |
| Est. Completion | 2035-09-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05938478
The ClinicalTrials.gov registry entry for NCT05938478 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 823 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Atopic Dermatitis appearing as the primary indexed condition, and to 1 intervention — of which Tralokinumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05938478 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05938478 about?
NCT05938478 is a clinical study titled "Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT". 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 differenc...
What is the current status of trial NCT05938478?
This trial is currently recruiting. The enrollment target is 900 participants. The study started on 2022-12-08. Estimated completion is 2035-09-30.
What conditions does trial NCT05938478 study?
This clinical trial studies the following conditions: Atopic Dermatitis, Eczema. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05938478?
The interventions under investigation include: Tralokinumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05938478?
This trial is sponsored by University of California, San Diego, which has 823 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05938478 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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