Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3
NCT ID: NCT03363854
Last Updated: 2025-03-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
380 participants
INTERVENTIONAL
2018-02-22
2019-09-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7
NCT03761537
Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)
NCT03131648
Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
NCT03526861
Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2)
NCT03160885
A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis
NCT06311682
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tralokinumab(initial)responders-> Tralokinumab(continuation A)
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.
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.
Tralokinumab(initial)responders-> Tralokinumab(continuation B)
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.
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.
Tralokinumab(initial)non-respon-> Tralokinumab(continuation A)
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.
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.
Placebo (initial)non-respon-> Tralokinumab(continuation A)
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.
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.
Placebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Placebo(initial)responders-> Placebo(continuation A)
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.
Placebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Placebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LEO Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama-Birmingham
Birmingham, Alabama, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
First OC Dermatology
Fountain Valley, California, United States
Center for Dermatology Clinical Research
Fremont, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Clinical Science Institute
Santa Monica, California, United States
Danbury Clinical Research
Danbury, Connecticut, United States
International Dermatology Research
Miami, Florida, United States
L & C Professional Medical Research
Miami, Florida, United States
Lenus Research & Medical Group
Sweetwater, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Medical Dermatology Specialists
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Indiana Clinical Trials Center
Plainfield, Indiana, United States
Study Center
Bangor, Maine, United States
Respiratory Medicine Research
Ypsilanti, Michigan, United States
Mount Sinai West Dermatoogy
New York, New York, United States
Wake Research
Raleigh, North Carolina, United States
Dermatologists of Greater Columbus
Bexley, Ohio, United States
Oregon Dermatology & Research
Portland, Oregon, United States
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, United States
University Hospital Antwerp
Antwerp, , Belgium
Universitair ziekenhuis Brussel
Brussels, , Belgium
Cliniques Universitaires St-Luc
Brussels, , Belgium
LEO Pharma Investigational Site
Loverval, , Belgium
Institute for Skin Advancement
Calgary, Alberta, Canada
Skin Care Centre
Vancouver, British Columbia, Canada
Maritime Medical Research Centre
Bathurst, New Brunswick, Canada
Eastern Canada Cutaneous Research
Halifax, Nova Scotia, Canada
CCA Medical Research
Ajax, Ontario, Canada
Simcoderm Medical and Surgical Dermatology Centre
Barrie, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
York Dermatology Center
Richmond Hill, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
XLR8 Medical Research
Windsor, Ontario, Canada
Interdisciplinary Study Association GmbH
Berlin, , Germany
St. Josef-Hospital, Ruhr-Universitet
Bochum, , Germany
Klinik und Poliklinik für Dermatologie und Allergologie
Bonn, , Germany
Klinikum der Johann Wolfgang Goethe-Universität Klinik
Frankfurt am Main, , Germany
MensingDerma Research GmbH
Hamburg, , Germany
Universitätsklinikum Jena
Jena, , Germany
Universitätshautklinik Kiel
Kiel, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Amcademic Medical Center
Amsterdam, , Netherlands
LEO Pharma Investigational Site
Bergen op Zoom, , Netherlands
LEO Pharma Investigational Site
Groningen, , Netherlands
Radboud MC
Nijmegen, , Netherlands
Erasmus MC, Rotterdam
Rotterdam, , Netherlands
University Medical Centre Utrecht
Utrecht, , Netherlands
Nzoz Med-Laser
Lublin, , Poland
LEO Pharma Investigational Site
Rzeszów, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
Wromedica s.c.
Wroclaw, , Poland
Derm Medica Sp.zo.o.
Wroclaw, , Poland
Hospital General de Alicante
Alicante, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Fundación Hospital Alcorcón
Madrid, , Spain
Hospital de Pontevedra
Pontevedra, , Spain
Hospital General de Valencia
Valencia, , Spain
Addenbooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
The Princess Alexandra Hospital
Harlow, Essex, United Kingdom
East Surrey Hospital
Redhill, Surrey, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, United Kingdom
Russells Hall Hospital
Dudley, West Midlands, United Kingdom
The Royal Free Hospital
London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Reich K, Langley RG, Salvador JFS, Staumont-Salle D, Costanzo A, Pink AE, Paller AS, Katoh N, Wollenberg A, Warren RB, Blauvelt A, Oland CB, Tindberg AM, Gjerum L, Simpson EL. Safety of tralokinumab in patients with moderate-to-severe atopic dermatitis followed for up to 4.5 years: an integrated analysis of 8 clinical trials. Br J Dermatol. 2025 Aug 29:ljaf309. doi: 10.1093/bjd/ljaf309. Online ahead of print.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-002065-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LP0162-1339
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.