Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)
Public ClinicalTrials.gov record NCT03562377. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effect of Tralokinumab on Vaccine Antibody Responses in Adults With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this trial is to test if treatment with the trial drug, tralokinumab, can affect the body's immune response to vaccines. The trial will also evaluate the efficacy of tralokinumab when it is given concomitantly with vaccines. The trial includes a screening period of 2 to 6 weeks, a treatment period of 16 weeks (Weeks 0 to 16), and a 14-week off-treatment follow-up period for the assessment of safety (Weeks 16 to 30). Eligible subjects may transfer to an open-label, long-term trial at Week 16 or later.
Study identification
- NCT ID
- NCT03562377
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 215 participants
Conditions and interventions
Conditions
Interventions
- Tralokinumab Drug
- Placebo Drug
- Tdap vaccine Biological
- Meningococcal vaccine Biological
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years to 54 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 13, 2018 (Actual)
- Primary completion
- Sep 17, 2019 (Actual)
- Completion
- Nov 22, 2019 (Actual)
- Last update posted
- Mar 11, 2025
2018 – 2019
United States locations
- U.S. sites
- 39
- U.S. states
- 18
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Leo Pharma Investigational Site | Fort Smith | Arkansas | 72916 | — |
| LEO Pharma Investigational Site | Bakersfield | California | 93301 | — |
| Leo Pharma Investigational Site | Beverly Hills | California | 90212 | — |
| Leo Pharma Investigational Site | Fountain Valley | California | 92708 | — |
| Leo Pharma Investigational Site | Los Angeles | California | 90025 | — |
| Leo Pharma Investigational Site | Los Angeles | California | 90045 | — |
| Leo Pharma Investigational Site | Los Angeles | California | 90057 | — |
| Leo Pharma Investigational Site | Newport Beach | California | 92660 | — |
| LEO Pharma Investigational Site | San Diego | California | 92123 | — |
| LEO Pharma Investigational Site | Centennial | Colorado | 80112 | — |
| LEO Pharma Investigational Site | Denver | Colorado | 80045 | — |
| LEO Pharma Investigational Site | Thornton | Colorado | 80233 | — |
| Leo Pharma Investigational Site | Coral Gables | Florida | 33134 | — |
| Leo Pharma Investigational Site | Doral | Florida | 33122 | — |
| Leo Pharma Investigational Site | Hialeah | Florida | 33012 | — |
| LEO Pharma Investigational Site | Atlanta | Georgia | 30328 | — |
| Leo Pharma Investigational Site | New Albany | Indiana | 47150 | — |
| Leo Pharma Investigational Site | South Bend | Indiana | 46617 | — |
| LEO Pharma Investigational Site | Bangor | Maine | 04401 | — |
| Leo Pharma Investigational Site | Boston | Massachusetts | 02115 | — |
| LEO Pharma Investigational Site | Brighton | Massachusetts | 02135 | — |
| Leo Pharma Investigational Site | Ann Arbor | Michigan | 48103 | — |
| LEO Pharma Investigational Site | Southfield | Michigan | 48034 | — |
| Leo Pharma Investigational Site | Missoula | Montana | 59808 | — |
| Leo Pharma Investigational Site | East Windsor | New Jersey | 08520 | — |
| LEO Pharma Investigational Site | Brooklyn | New York | 11201 | — |
| Leo Pharma Investigational Site | Cortland | New York | 13045 | — |
| Leo Pharma Investigational Site | Forest Hills | New York | 11375 | — |
| Leo Pharma Investigational Site | New York | New York | 10021 | — |
| Leo Pharma Investigational Site | Cincinnati | Ohio | 45219 | — |
| LEO Pharma Investigational Site | Cincinnati | Ohio | 45231 | — |
| LEO Pharma Investigational Site | Gahanna | Ohio | 43230 | — |
| LEO Pharma Investigational Site | Medford | Oregon | 97504 | — |
| Leo Pharma Investigational Site | Chattanooga | Tennessee | 37421 | — |
| Leo Pharma Investigational Site | Austin | Texas | 78759 | — |
| LEO Pharma Investigational Site | Dallas | Texas | 75225 | — |
| Leo Pharma Investigational Site | Frisco | Texas | 75034 | — |
| Leo Pharma Investigational Site | South Burlington | Vermont | 05403 | — |
| Leo Pharma Investigational Site | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03562377, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 11, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03562377 live on ClinicalTrials.gov.