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NCT05938478 · ClinicalTrials.gov registry record
Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
A clinical trial of Atopic Dermatitis and Eczema, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- 900
- Enrollment target
- 1
- Study location
NCT05938478: Recruiting study of Atopic Dermatitis and Eczema, sponsored by University of California, San Diego.
NCT05938478 is a study of Atopic Dermatitis and Eczema that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 900 participants, above the 603-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (49% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05938478, a study of Atopic Dermatitis and Eczema, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- 900 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Major structural defects is defined and classified using the US Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects. All major structural defects will be adjudicated by the co-investigator on this study.
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 |
What NCT05938478 shows while recruiting
NCT05938478 is an observational study that tracks outcomes without assigning an intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, above the 603-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (49% higher).
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.
NCT05938478 reports a single indexed study location in California.
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.
What interventions are being tested in trial NCT05938478?
The interventions under investigation include: Tralokinumab (DRUG).
Who is sponsoring clinical trial NCT05938478?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Atopic Dermatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05938478's enrollment target sits among peer trials
900 16th of 150 higher than 135 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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