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Completed Phase 3 Interventional Results available

Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3

ClinicalTrials.gov ID: NCT03363854

Public ClinicalTrials.gov record NCT03363854. 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.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 8:33 PM EDT

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 in Combination With Topical Corticosteroids in Subjects With Moderate to Severe Atopic Dermatitis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared with placebo in combination with TCS. To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.

Study identification

NCT ID
NCT03363854
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
LEO Pharma
Industry
Enrollment
380 participants

Conditions and interventions

Interventions

Drug

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
Feb 22, 2018 (Actual)
Primary completion
Mar 8, 2019 (Actual)
Completion
Sep 26, 2019 (Actual)
Last update posted
Mar 11, 2025

2018 – 2019

United States locations

U.S. sites
21
U.S. states
14
U.S. cities
20
Facility City State ZIP Site status
University of Alabama-Birmingham Birmingham Alabama 35233 —
California Dermatology & Clinical Research Institute Encinitas California 92024 —
First OC Dermatology Fountain Valley California 92708 —
Center for Dermatology Clinical Research Fremont California 94538 —
Dermatology Research Associates Los Angeles California 90045 —
Clinical Science Institute Santa Monica California 90404 —
Danbury Clinical Research Danbury Connecticut 06810 —
International Dermatology Research Miami Florida 33144 —
L & C Professional Medical Research Miami Florida 33144 —
Lenus Research & Medical Group Sweetwater Florida 33172 —
Olympian Clinical Research Tampa Florida 33614 —
Medical Dermatology Specialists Atlanta Georgia 30328 —
Northwestern University Chicago Illinois 60611 —
Indiana Clinical Trials Center Plainfield Indiana 46168 —
Study Center Bangor Maine 04401 —
Respiratory Medicine Research Ypsilanti Michigan 48197 —
Mount Sinai West Dermatoogy New York New York 10023 —
Wake Research Raleigh North Carolina 27612 —
Dermatologists of Greater Columbus Bexley Ohio 43209 —
Oregon Dermatology & Research Portland Oregon 97210 —
National Allergy and Asthma Research, LLC North Charleston South Carolina 29420 —

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 45 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03363854, 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 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03363854 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →