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Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)

NCT03131648 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 802

Last updated 2025-03-11

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Tralokinumab

Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration

DRUG

Placebo

Placebo contains the same excipients, in the same concentration only lacking tralokinumab

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Andreas Wollenberg, Prof. Dr. med. · Department of Dermatology and Allergy, Ludwig-Maximilian University Munich, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2018-08-07
Completion
2019-10-10
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Japan
  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03131648 on ClinicalTrials.gov