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

NCT03363854 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: LP0162-13392017-002065-21
• Study Type: interventional
• Target: 380
• Locations: 8 countries
• Sites: 66

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16

  IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).

  Week 16

• Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16

  EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.

  Week 16

Secondary Outcomes (17)

• Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16

  Week 0 to Week 16

• Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16

  Week 0 to Week 16

• Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16

  Week 0 to Week 16

• Frequency of Anti-drug Antibodies (ADA)

  Week 0 to Week 16, Week 16 to Week 32

• Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes

  Week 1-2 to Week 15-16

Study Arms (5)

Tralokinumab(initial)responders-> Tralokinumab(continuation A)

EXPERIMENTAL

Week 0 to 16 (initial period): Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen A.

Drug: Tralokinumab

Tralokinumab(initial)responders-> Tralokinumab(continuation B)

EXPERIMENTAL

Week 0 to 16 (initial period): Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen B.

Drug: Tralokinumab

Tralokinumab(initial)non-respon-> Tralokinumab(continuation A)

EXPERIMENTAL

Week 0 to 16 (initial period): Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen A.

Drug: Tralokinumab

Placebo (initial)non-respon-> Tralokinumab(continuation A)

EXPERIMENTAL

Week 0 to 16 (initial period): Placebo loading SC injection on Day 0 followed by placebo injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen A.

Drug: Tralokinumab; Drug: Placebo

Placebo(initial)responders-> Placebo(continuation A)

PLACEBO COMPARATOR

Week 0 to 16 (initial period): Placebo loading SC injection on Day 0 followed by placebo injection regimen A. Week 16 to 32 (continuation period): Placebo continuation SC injection regimen A.

Drug: Placebo

Interventions

Tralokinumab DRUG

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.

Placebo (initial)non-respon-> Tralokinumab(continuation A); Tralokinumab(initial)non-respon-> Tralokinumab(continuation A); Tralokinumab(initial)responders-> Tralokinumab(continuation A); Tralokinumab(initial)responders-> Tralokinumab(continuation B)

Placebo DRUG

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

Placebo (initial)non-respon-> Tralokinumab(continuation A); Placebo(initial)responders-> Placebo(continuation A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above.
• Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
• History of AD for ≥1 year.
• Subjects who have a recent history of inadequate response to treatment with topical medications.
• AD involvement of ≥10% body surface area at screening and baseline.
• Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.

You may not qualify if:

• Subjects for whom TCS are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator.
• Active dermatologic conditions that may confound the diagnosis of AD.
• Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
• Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
• Treatment with TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
• Receipt of any marketed biological therapy (i.e. immunoglobulin, anti- immunoglobulin E) including dupilumab or investigational biologic agents within 3 months or 5 half-lives, whichever is longer prior to randomisation.
• Active skin infection within 1 week prior to randomisation.
• Clinically significant infection within 4 weeks prior to randomisation.
• A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
• Tuberculosis requiring treatment within the 12 months prior to screening.
• Known primary immunodeficiency disorder.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (66)

University of Alabama-Birmingham

Birmingham, Alabama, 35233, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Danbury Clinical Research

Danbury, Connecticut, 06810, United States

Location

International Dermatology Research

Miami, Florida, 33144, United States

Location

L & C Professional Medical Research

Miami, Florida, 33144, United States

Location

Lenus Research & Medical Group

Sweetwater, Florida, 33172, United States

Location

Olympian Clinical Research

Tampa, Florida, 33614, United States

Location

Medical Dermatology Specialists

Atlanta, Georgia, 30328, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Study Center

Bangor, Maine, 04401, United States

Location

Respiratory Medicine Research

Ypsilanti, Michigan, 48197, United States

Location

Mount Sinai West Dermatoogy

New York, New York, 10023, United States

Location

Wake Research

Raleigh, North Carolina, 27612, United States

Location

Dermatologists of Greater Columbus

Bexley, Ohio, 43209, United States

Location

Oregon Dermatology & Research

Portland, Oregon, 97210, United States

Location

National Allergy and Asthma Research, LLC

North Charleston, South Carolina, 29420, United States

Location

University Hospital Antwerp

Antwerp, 2650, Belgium

Location

Universitair ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

LEO Pharma Investigational Site

Loverval, 6280, Belgium

Location

Institute for Skin Advancement

Calgary, Alberta, T3A 2N1, Canada

Location

Skin Care Centre

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Maritime Medical Research Centre

Bathurst, New Brunswick, E2A 4Z9, Canada

Location

Eastern Canada Cutaneous Research

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

CCA Medical Research

Ajax, Ontario, L1S 7K8, Canada

Location

Simcoderm Medical and Surgical Dermatology Centre

Barrie, Ontario, L4M 6L2, Canada

Location

DermEdge Research

Mississauga, Ontario, L5H 1G9, Canada

Location

York Dermatology Center

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Research Toronto

Toronto, Ontario, M4W 2N2, Canada

Location

XLR8 Medical Research

Windsor, Ontario, N8W 1E6, Canada

Location

Interdisciplinary Study Association GmbH

Berlin, 10780, Germany

Location

St. Josef-Hospital, Ruhr-Universitet

Bochum, 44791, Germany

Location

Klinik und Poliklinik für Dermatologie und Allergologie

Bonn, 53105, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität Klinik

Frankfurt am Main, 60590, Germany

Location

MensingDerma Research GmbH

Hamburg, 22391, Germany

Location

Universitätsklinikum Jena

Jena, 07743, Germany

Location

Universitätshautklinik Kiel

Kiel, 24105, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Amcademic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

LEO Pharma Investigational Site

Bergen op Zoom, 4614 VT, Netherlands

Location

LEO Pharma Investigational Site

Groningen, 9713 GZ, Netherlands

Location

Radboud MC

Nijmegen, 6525, Netherlands

Location

Erasmus MC, Rotterdam

Rotterdam, 3015 CA, Netherlands

Location

University Medical Centre Utrecht

Utrecht, 3584 CX, Netherlands

Location

Nzoz Med-Laser

Lublin, 20-146, Poland

Location

LEO Pharma Investigational Site

Rzeszów, 35-055, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, 01-0141, Poland

Location

Wromedica s.c.

Wroclaw, 50-001, Poland

Location

Derm Medica Sp.zo.o.

Wroclaw, 51-318, Poland

Location

Hospital General de Alicante

Alicante, 03010, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Fundación Hospital Alcorcón

Madrid, 28922, Spain

Location

Hospital de Pontevedra

Pontevedra, 36003, Spain

Location

Hospital General de Valencia

Valencia, 46014, Spain

Location

Addenbooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

The Princess Alexandra Hospital

Harlow, Essex, CM20 1QX, United Kingdom

Location

East Surrey Hospital

Redhill, Surrey, RH1 5RH, United Kingdom

Location

Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Russells Hall Hospital

Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

The Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Related Publications (5)

• Mayo T, Silverberg JI, Armstrong A, Guttman-Yassky E, Blauvelt A, Esdaile B, Kabashima K, Gooderham M, Kircik L, Schneider S, Bennike N, von Eyben R, Martel BC, Ropke MA, Katoh N, Alexis AF. Efficacy and Safety of Tralokinumab Across Racial Subgroups in Adults with Moderate-to-Severe Atopic Dermatitis: Post Hoc Analysis of Phase III Trials. Am J Clin Dermatol. 2025 Oct 21. doi: 10.1007/s40257-025-00985-1. Online ahead of print.

  PMID: 41118053 DERIVED

• Wiseman M, Benvenuto M, Stromkjaer L, Paludan-Muller A, Ryttig L, Petersen AS, Wollenberg A. Cost-Per-Responder Analysis for Tralokinumab and Dupilumab in Combination with Topical Corticosteroids in Patients with Moderate-To-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Oct 16. doi: 10.1007/s13555-025-01565-1. Online ahead of print.

  PMID: 41102518 DERIVED

• Paller AS, Soong W, Boguniewicz M, Geng B, Thyssen JP, Bennike N, Schneider S, Wollenberg A. Effect of tralokinumab on moderate-to-severe atopic dermatitis in patients with atopic comorbidities. Ann Allergy Asthma Immunol. 2025 Oct;135(4):425-433.e4. doi: 10.1016/j.anai.2025.06.022. Epub 2025 Jun 22.

  PMID: 40555305 DERIVED

• Blauvelt A, Gooderham M, Bhatia N, Langley RG, Schneider S, Zoidis J, Kurbasic A, Armstrong A, Silverberg JI. Tralokinumab Efficacy and Safety, with or without Topical Corticosteroids, in North American Adults with Moderate-to-Severe Atopic Dermatitis: A Subanalysis of Phase 3 Trials ECZTRA 1, 2, and 3. Dermatol Ther (Heidelb). 2022 Nov;12(11):2499-2516. doi: 10.1007/s13555-022-00805-y. Epub 2022 Sep 24.

  PMID: 36152216 DERIVED

• Silverberg JI, Adam DN, Zirwas M, Kalia S, Gutermuth J, Pinter A, Pink AE, Chiricozzi A, Barbarot S, Mark T, Tindberg AM, Weidinger S. Tralokinumab Plus Topical Corticosteroids as Needed Provides Progressive and Sustained Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Over a 32-Week Period: An ECZTRA 3 Post Hoc Analysis. Am J Clin Dermatol. 2022 Jul;23(4):547-559. doi: 10.1007/s40257-022-00702-2. Epub 2022 Jul 20.

  PMID: 35857179 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

tralokinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Disclosure
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 44 94 58 88

Study Officials

• Medical expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the subject nor any of the investigator or LEO staff who are involved in the treatment or clinical evaluation and monitoring of the subjects will be aware of the treatment received. The packaging and labelling of the investigational medicinal products (IMPs) will contain no evidence of their identity. Since tralokinumab and placebo are visually distinct and not matched for viscosity, IMP will be handled and administered by a qualified, unblinded health-care professional at the site who will not be involved in the management of trial subjects and who will not perform any of the assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 6, 2017
• Study Start: February 22, 2018
• Primary Completion: March 8, 2019
• Study Completion: September 26, 2019
• Last Updated: March 11, 2025
• Results First Posted: January 14, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8); PL (5); CA (10); NL (6); ES (5); GB (7); US (21); BE (4)