Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)
Public ClinicalTrials.gov record NCT03131648. 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, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects 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.
Primary objective: To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (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. Maintenance objective: To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.
Study identification
- NCT ID
- NCT03131648
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 802 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- May 29, 2017
- Primary completion
- Aug 6, 2018
- Completion
- Oct 9, 2019
- Last update posted
- Mar 10, 2025
2017 – 2019
United States locations
- U.S. sites
- 44
- U.S. states
- 22
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | — |
| Tien Q. Nguyen, MD, Inc. | Fountain Valley | California | 92708 | — |
| Dermatology Research Associates | Los Angeles | California | 90045 | — |
| Quest Dermatology Research | Northridge | California | 91324 | — |
| Dermatology Specialists, Inc. | Oceanside | California | 92056 | — |
| Center for Dermatology and Laser Surgery | Sacramento | California | 95819 | — |
| University Clinical Trials, Inc. | San Diego | California | 92123 | — |
| The GWU Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| Skin Care Research, Inc. | Boca Raton | Florida | 33486 | — |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | — |
| Forward Clinical Trials | Tampa | Florida | 33624 | — |
| Research Institute of the Southeast, LLC | West Palm Beach | Florida | 33401 | — |
| ACRC Dermatology | West Palm Beach | Florida | 33406 | — |
| Georgia Pollens Clinical Research Centers, Inc. | Albany | Georgia | 31707 | — |
| Allergy Center at Brookstone Research | Columbus | Georgia | 31904 | — |
| Dermatologic Surgery Specialists | Macon | Georgia | 31217 | — |
| Meridian Clinical Research | Savannah | Georgia | 31406 | — |
| Altman Dermatology Associates | Arlington Heights | Illinois | 60005 | — |
| PMG Research of Christie Clinic | Chicago | Illinois | 61820 | — |
| Deaconess Clinic | Evansville | Indiana | 47713 | — |
| Skin Sciences, PLLC | Louisville | Kentucky | 40217 | — |
| Clinical Trials of SWLA, LLC | Lake Charles | Louisiana | 70601 | — |
| DermAssociates, PC | Rockville | Maryland | 20850 | — |
| Clarkston Skin Research | Clarkston | Michigan | 48346 | — |
| Derm Center | Troy | Michigan | 48084 | — |
| MediSearch LLC | Saint Joseph | Missouri | 64506 | — |
| JDR Dermatology Research | Las Vegas | Nevada | 89148 | — |
| University at Buffalo Department of Dermatology | Buffalo | New York | 14203 | — |
| Weil Cornell Medicine | New York | New York | 10021 | — |
| Juva Skin & Laser Center | New York | New York | 10022 | — |
| Deramatology Consulting Services, PLLC | High Point | North Carolina | 27262 | — |
| Dermatologists of Greater Columbus | Bexley | Ohio | 43209 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Oregon Medical Research Center | Portland | Oregon | 97223 | — |
| Oregon Health & Sciences University | Portland | Oregon | 97239 | — |
| UPMC Department of Dermatology | Pittsburgh | Pennsylvania | 15213 | — |
| Austin Dermatology Associates | Austin | Texas | 78705 | — |
| Tekton Research | Austin | Texas | 78745 | — |
| Dermtology Treatment and Research Center | Dallas | Texas | 75230 | — |
| Houston Skin Associates | Houston | Texas | 77004 | — |
| Center for Clinical Studies | Webster | Texas | 77958 | — |
| Virginia Clinical Research | Norfolk | Virginia | 23502 | — |
| Dermatology Associates of Seattle | Seattle | Washington | 98101 | — |
| West Virginia Research Institute | Morgantown | West Virginia | 26505 | — |
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 79 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03131648, 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 10, 2025 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03131648 live on ClinicalTrials.gov.