Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
Public ClinicalTrials.gov record NCT03526861. 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, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary objective: To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD. Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo. To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD.
Study identification
- NCT ID
- NCT03526861
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 301 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 17 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
- Jun 19, 2018 (Actual)
- Primary completion
- Apr 15, 2020 (Actual)
- Completion
- Mar 16, 2021 (Actual)
- Last update posted
- Mar 11, 2025
2018 – 2021
United States locations
- U.S. sites
- 29
- U.S. states
- 21
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| LEO Pharma Investigational Site | Birmingham | Alabama | 35209 | — |
| LEO Pharma Investigational Site | Fort Smith | Arkansas | 72916 | — |
| Leo Pharma Investigational Site | Fountain Valley | California | 92708 | — |
| LEO Pharma Investigational Site | Los Angeles | California | 90045 | — |
| LEO Pharma Investigational Site | San Francisco | California | 94132 | — |
| LEO Pharma Investigational Site | Stanford | California | 94304 | — |
| LEO Pharma Investigational Site | New Haven | Connecticut | 06520-8059 | — |
| LEO Pharma Investigational Site | Miami | Florida | 33137 | — |
| Leo Pharma Investigational Site | Albany | Georgia | 31707 | — |
| LEO Pharma Investigational Site | Chicago | Illinois | 60611 | — |
| LEO Pharma Investigational Site | Louisville | Kentucky | 40215 | — |
| LEO Pharma Investigational Site | Baton Rouge | Louisiana | 70808 | — |
| LEO Pharma Investigational Site | Ann Arbor | Michigan | 48103 | — |
| LEO Pharma Investigational Site | Ypsilanti | Michigan | 48197 | — |
| LEO Pharma Investigational Site | Minneapolis | Minnesota | 55402 | — |
| LEO Pharma Investigational Site | East Windsor | New Jersey | 08520 | — |
| LEO Pharma Investigational Site | Corning | New York | 14830 | — |
| Leo Pharma Investigational Site | New York | New York | 10075 | — |
| LEO Pharma Investigational Site | High Point | North Carolina | 27262 | — |
| LEO Pharma Investigational Site | Bexley | Ohio | 43209 | — |
| Leo Pharma Investigational Site | Tulsa | Oklahoma | 74136 | — |
| LEO Pharma Investigational Site | Portland | Oregon | 97223 | — |
| LEO Pharma Investigational Site | Portland | Oregon | 97239 | — |
| LEO Pharma Investigational Site | Philadelphia | Pennsylvania | 19104 | — |
| Leo Pharma Investigational Site | North Charleston | South Carolina | 29420 | — |
| Leo Pharma Investigational Site | Murfreesboro | Tennessee | 37130 | — |
| LEO Pharma Investigational Site | Austin | Texas | 78746 | — |
| LEO Pharma Investigational Site | Houston | Texas | 77030 | — |
| Leo Pharma Investigational Site | San Antonio | Texas | 78218 | — |
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 58 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03526861, 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 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03526861 live on ClinicalTrials.gov.