Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
NCT ID: NCT03526861
Last Updated: 2025-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
301 participants
INTERVENTIONAL
2018-06-19
2021-03-16
Brief Summary
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To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to \<18 years) with moderate-to-severe 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.
To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceA
Week 0 to 16 (initial period):
Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.
Week 16 to 52 (maintenance period):
Tralokinumab (Dose 1) maintenance SC injection regimen A.
Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceB
Week 0 to 16 (initial period):
Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.
Week 16 to 52 (maintenance period):
Tralokinumab (Dose 1) maintenance SC injection regimen B.
Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceA
Week 0 to 16 (initial period):
Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.
Week 16 to 52 (maintenance period):
Tralokinumab (Dose 2) maintenance SC injection regimen A.
Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceB
Week 0 to 16 (initial period):
Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.
Week 16 to 52 (maintenance period):
Tralokinumab (Dose 2) maintenance SC injection regimen B.
Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Placebo initial-> Placebo maintenance
Week 0 to 16 (initial period):
Placebo loading SC injection on Day 0 followed by placebo injection regimen A.
Week 16 to 52 (maintenance period):
Placebo continuation SC injection regimen A.
Placebos
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Tralokinumab (Dose1) initial-> Open-label tralokinumab
Week 0 to 16 (initial period):
Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.
Week 16 to 52:
Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids
Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Tralokinumab (Dose2) initial-> Open-label tralokinumab
Week 0 to 16 (initial period):
Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.
Week 16 to 52:
Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids
Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Placebo initial-> Open-label tralokinumab
Week 0 to 16 (initial period):
Placebo loading SC injection on Day 0 followed by placebo injection regimen A.
Week 16 to 52:
Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids
Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Placebos
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Interventions
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Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.
Placebos
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
* History of AD for ≥1 year.
* History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable.
* 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
* 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, 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.
* 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.
12 Years
17 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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LEO Pharma Investigational Site
Birmingham, Alabama, United States
LEO Pharma Investigational Site
Fort Smith, Arkansas, United States
Leo Pharma Investigational Site
Fountain Valley, California, United States
LEO Pharma Investigational Site
Los Angeles, California, United States
LEO Pharma Investigational Site
San Francisco, California, United States
LEO Pharma Investigational Site
Stanford, California, United States
LEO Pharma Investigational Site
New Haven, Connecticut, United States
LEO Pharma Investigational Site
Miami, Florida, United States
Leo Pharma Investigational Site
Albany, Georgia, United States
LEO Pharma Investigational Site
Chicago, Illinois, United States
LEO Pharma Investigational Site
Louisville, Kentucky, United States
LEO Pharma Investigational Site
Baton Rouge, Louisiana, United States
LEO Pharma Investigational Site
Ann Arbor, Michigan, United States
LEO Pharma Investigational Site
Ypsilanti, Michigan, United States
LEO Pharma Investigational Site
Minneapolis, Minnesota, United States
LEO Pharma Investigational Site
East Windsor, New Jersey, United States
LEO Pharma Investigational Site
Corning, New York, United States
Leo Pharma Investigational Site
New York, New York, United States
LEO Pharma Investigational Site
High Point, North Carolina, United States
LEO Pharma Investigational Site
Bexley, Ohio, United States
Leo Pharma Investigational Site
Tulsa, Oklahoma, United States
LEO Pharma Investigational Site
Portland, Oregon, United States
LEO Pharma Investigational Site
Portland, Oregon, United States
LEO Pharma Investigational Site
Philadelphia, Pennsylvania, United States
Leo Pharma Investigational Site
North Charleston, South Carolina, United States
Leo Pharma Investigational Site
Murfreesboro, Tennessee, United States
LEO Pharma Investigational Site
Austin, Texas, United States
LEO Pharma Investigational Site
Houston, Texas, United States
Leo Pharma Investigational Site
San Antonio, Texas, United States
Leo Pharma Investigationel Site
Darlinghurst, , Australia
Leo Pharma Investigationel Site
Kogarah, , Australia
Leo Pharma Investigationel Site
Melbourne, , Australia
Leo Pharma Investigationel Site
Woolloongabba, , Australia
Leo Pharma Investigationel Site
Brussels, , Belgium
Leo Pharma Investigationel Site
Ghent, , Belgium
Leo Pharma Investigationel Site
Liège, , Belgium
Leo Pharma Investigational Site
Maldegem, , Belgium
LEO Pharma Investigational Site
Calgary, Alberta, Canada
LEO Pharma Investigational Site
Edmonton, Alberta, Canada
LEO Pharma Investigational Site
Surrey, British Columbia, Canada
LEO Pharma Investigational Site
Winnipeg, Manitoba, Canada
LEO Pharma Investigational Site
Winnipeg, Manitoba, Canada
LEO Pharma Investigational Site
Markham, Ontario, Canada
LEO Pharma Investigational Site
Oakville, Ontario, Canada
LEO Pharma Investigational Site
Toronto, Ontario, Canada
LEO Pharma Investigational Site
Windsor, Ontario, Canada
LEO Pharma Investigational Site
Montreal, Quebec, Canada
LEO Pharma Investigational Site
Saskatoon, Saskatchewan, Canada
Leo Pharma Investigationel Site
Marseille, , France
Leo Pharma Investigationel Site
Nice, , France
Leo Pharma Investigationel Site
Paris, , France
Leo Pharma Investigationel Site
Paris, , France
Leo Pharma Investigationel Site
Valence, , France
Leo Pharma Investigationel Site
Berlin, , Germany
Leo Pharma Investigationel Site
Dresden, , Germany
Leo Pharma Investigationel Site
Jena, , Germany
Leo Pharma Investigationel Site
Osnabrück, , Germany
Leo Pharma Investigationel Site
Fukuoka, , Japan
Leo Pharma Investigationel Site
Kagoshima, , Japan
Leo Pharma Investigationel Site
Kyoto, , Japan
Leo Pharma Investigationel Site
Nagoya, , Japan
Leo Pharma Investigationel Site
Obihiro, , Japan
Leo Pharma Investigationel Site
Osaka, , Japan
Leo Pharma Investigationel Site
Osaka-fu, , Japan
Leo Pharma Investigationel Site
Shimotsuke, , Japan
Leo Pharma Investigationel Site
Tokyo, , Japan
Leo Pharma Investigationel Site
Tokyo, , Japan
Leo Pharma Investigationel Site
Tokyo, , Japan
Leo Pharma Investigationel Site
Tokyo, , Japan
Leo Pharma Investigationel Site
Tsu, , Japan
Leo Pharma Investigationel Site
Yamanashi, , Japan
Leo Pharma Investigationel Site
Bergen op Zoom, , Netherlands
Leo Pharma Investigationel Site
Breda, , Netherlands
Leo Pharma Investigationel Site
Groningen, , Netherlands
Leo Pharma Investigationel Site
Rotterdam, , Netherlands
Leo Pharma Investigationel Site
Krakow, , Poland
Leo Pharma Investigationel Site
Krakow, , Poland
Leo Pharma Investigationel Site
Krakow, , Poland
Leo Pharma Investigationel Site
Lodz, , Poland
Leo Pharma Investigationel Site
Lodz, , Poland
Leo Pharma Investigationel Site
Rzeszów, , Poland
Leo Pharma Investigationel Site
Świdnik, , Poland
Leo Pharma Investigationel Site
Wroclaw, , Poland
Leo Pharma Investigationel Site
Wroclaw, , Poland
Leo Pharma Investigationel Site
Wroclaw, , Poland
Leo Pharma Investigationel Site
Glasgow, , United Kingdom
Leo Pharma Investigationel Site
London, , United Kingdom
Countries
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References
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Paller AS, Flohr C, Cork M, Bewley A, Blauvelt A, Hong HC, Imafuku S, Schuttelaar MLA, Simpson EL, Soong W, Arlert P, Lophaven KW, Kurbasic A, Soldbro L, Vest NS, Wollenberg A. Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial. JAMA Dermatol. 2023 Jun 1;159(6):596-605. doi: 10.1001/jamadermatol.2023.0627.
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, Blauvelt A, Soong W, Chih-Ho Hong H, Schuttelaar MLA, Schneider SKR, Simpson EL. Clinically Meaningful Improvements in Adolescents with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab who did not Achieve Clear or Almost Clear Skin at Week 16. Dermatol Ther (Heidelb). 2025 Oct;15(10):2879-2896. doi: 10.1007/s13555-025-01484-1. Epub 2025 Jul 28.
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.
Soehoel A, Larsen MS, Timmermann S. Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis. Clin Pharmacol Drug Dev. 2022 Aug;11(8):910-921. doi: 10.1002/cpdd.1113. Epub 2022 Jun 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-005143-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LP0162-1334
Identifier Type: -
Identifier Source: org_study_id
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