Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).

NCT03526861 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: LP0162-13342017-005143-33
• Study Type: interventional
• Target: 301
• Locations: 10 countries
• Sites: 87

Brief Summary

Primary objective: 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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

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

  The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  At Week 16

• Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16

  The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.

  At Week 16

Secondary Outcomes (17)

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

  At Week 16

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

  From Week 0 to Week 16

• Change in Children's Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16

  From Week 0 to Week 16

• Number of Adverse Events

  From Week 0 to Week 16

• Presence of Anti-drug Antibodies

  From Week 0 to Week 16

Study Arms (8)

Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceA

EXPERIMENTAL

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.

Drug: Tralokinumab

Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceB

EXPERIMENTAL

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.

Drug: Tralokinumab

Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceA

EXPERIMENTAL

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.

Drug: Tralokinumab

Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceB

EXPERIMENTAL

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.

Drug: Tralokinumab

Placebo initial-> Placebo maintenance

EXPERIMENTAL

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.

Drug: Placebos

Tralokinumab (Dose1) initial-> Open-label tralokinumab

EXPERIMENTAL

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

Drug: Tralokinumab

Tralokinumab (Dose2) initial-> Open-label tralokinumab

EXPERIMENTAL

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

Drug: Tralokinumab

Placebo initial-> Open-label tralokinumab

EXPERIMENTAL

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

Drug: Tralokinumab; Drug: Placebos

Interventions

Tralokinumab DRUG

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; Tralokinumab (Dose1) initial-> Open-label tralokinumab; Tralokinumab (Dose2) initial-> Open-label tralokinumab; Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceA; Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceB; Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceA; Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceB

Placebos DRUG

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

Also known as: Placebo

Placebo initial-> Open-label tralokinumab; Placebo initial-> Placebo maintenance

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 12 to 17.
• 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.

You may not qualify if:

• 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, 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (87)

LEO Pharma Investigational Site

Birmingham, Alabama, 35209, United States

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LEO Pharma Investigational Site

Fort Smith, Arkansas, 72916, United States

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Leo Pharma Investigational Site

Fountain Valley, California, 92708, United States

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LEO Pharma Investigational Site

Los Angeles, California, 90045, United States

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LEO Pharma Investigational Site

San Francisco, California, 94132, United States

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LEO Pharma Investigational Site

Stanford, California, 94304, United States

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LEO Pharma Investigational Site

New Haven, Connecticut, 06520-8059, United States

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LEO Pharma Investigational Site

Miami, Florida, 33137, United States

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Leo Pharma Investigational Site

Albany, Georgia, 31707, United States

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LEO Pharma Investigational Site

Chicago, Illinois, 60611, United States

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LEO Pharma Investigational Site

Louisville, Kentucky, 40215, United States

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LEO Pharma Investigational Site

Baton Rouge, Louisiana, 70808, United States

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LEO Pharma Investigational Site

Ann Arbor, Michigan, 48103, United States

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LEO Pharma Investigational Site

Ypsilanti, Michigan, 48197, United States

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LEO Pharma Investigational Site

Minneapolis, Minnesota, 55402, United States

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LEO Pharma Investigational Site

East Windsor, New Jersey, 08520, United States

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LEO Pharma Investigational Site

Corning, New York, 14830, United States

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Leo Pharma Investigational Site

New York, New York, 10075, United States

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LEO Pharma Investigational Site

High Point, North Carolina, 27262, United States

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LEO Pharma Investigational Site

Bexley, Ohio, 43209, United States

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Leo Pharma Investigational Site

Tulsa, Oklahoma, 74136, United States

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LEO Pharma Investigational Site

Portland, Oregon, 97223, United States

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LEO Pharma Investigational Site

Portland, Oregon, 97239, United States

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LEO Pharma Investigational Site

Philadelphia, Pennsylvania, 19104, United States

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Leo Pharma Investigational Site

North Charleston, South Carolina, 29420, United States

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Leo Pharma Investigational Site

Murfreesboro, Tennessee, 37130, United States

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LEO Pharma Investigational Site

Austin, Texas, 78746, United States

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LEO Pharma Investigational Site

Houston, Texas, 77030, United States

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Leo Pharma Investigational Site

San Antonio, Texas, 78218, United States

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Leo Pharma Investigationel Site

Darlinghurst, 2010, Australia

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Leo Pharma Investigationel Site

Kogarah, 2217, Australia

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Leo Pharma Investigationel Site

Melbourne, 3002, Australia

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Leo Pharma Investigationel Site

Woolloongabba, 4102, Australia

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Leo Pharma Investigationel Site

Brussels, 1200, Belgium

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Leo Pharma Investigationel Site

Ghent, B-9000, Belgium

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Leo Pharma Investigationel Site

Liège, 4000, Belgium

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Leo Pharma Investigational Site

Maldegem, 9990, Belgium

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LEO Pharma Investigational Site

Calgary, Alberta, T3A 2N1, Canada

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LEO Pharma Investigational Site

Edmonton, Alberta, T6G 1C9, Canada

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LEO Pharma Investigational Site

Surrey, British Columbia, V3R 6A7, Canada

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LEO Pharma Investigational Site

Winnipeg, Manitoba, R3C 1T6, Canada

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LEO Pharma Investigational Site

Winnipeg, Manitoba, R3M 3Z4, Canada

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LEO Pharma Investigational Site

Markham, Ontario, L3P 1X2, Canada

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LEO Pharma Investigational Site

Oakville, Ontario, L6J 7W5, Canada

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LEO Pharma Investigational Site

Toronto, Ontario, M5A 3R6, Canada

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LEO Pharma Investigational Site

Windsor, Ontario, N8X 2G1, Canada

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LEO Pharma Investigational Site

Montreal, Quebec, H3T 1C5, Canada

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LEO Pharma Investigational Site

Saskatoon, Saskatchewan, S7K 0H6, Canada

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Leo Pharma Investigationel Site

Marseille, 13285, France

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Leo Pharma Investigationel Site

Nice, 06200, France

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Leo Pharma Investigationel Site

Paris, 75015, France

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Leo Pharma Investigationel Site

Paris, 75020, France

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Leo Pharma Investigationel Site

Valence, 26000, France

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Leo Pharma Investigationel Site

Berlin, 10115, Germany

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Leo Pharma Investigationel Site

Dresden, 01307, Germany

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Leo Pharma Investigationel Site

Jena, 49074, Germany

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Leo Pharma Investigationel Site

Osnabrück, 49074, Germany

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Leo Pharma Investigationel Site

Fukuoka, 814-0180, Japan

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Leo Pharma Investigationel Site

Kagoshima, 890-8520, Japan

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Leo Pharma Investigationel Site

Kyoto, 602-8566, Japan

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Leo Pharma Investigationel Site

Nagoya, 457-8510, Japan

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Leo Pharma Investigationel Site

Obihiro, 080-0013, Japan

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Leo Pharma Investigationel Site

Osaka, 593-8324, Japan

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Leo Pharma Investigationel Site

Osaka-fu, 560-0085, Japan

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Leo Pharma Investigationel Site

Shimotsuke, 329-0498, Japan

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Leo Pharma Investigationel Site

Tokyo, 136-0074, Japan

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Leo Pharma Investigationel Site

Tokyo, 141-8625, Japan

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Leo Pharma Investigationel Site

Tokyo, 169-0075, Japan

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Leo Pharma Investigationel Site

Tokyo, 171-0022, Japan

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Leo Pharma Investigationel Site

Tsu, 514-8507, Japan

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Leo Pharma Investigationel Site

Yamanashi, 400-8506, Japan

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Leo Pharma Investigationel Site

Bergen op Zoom, 4708, Netherlands

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Leo Pharma Investigationel Site

Breda, 4818, Netherlands

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Leo Pharma Investigationel Site

Groningen, 9713, Netherlands

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Leo Pharma Investigationel Site

Rotterdam, 3015, Netherlands

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Leo Pharma Investigationel Site

Krakow, 30-033, Poland

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Leo Pharma Investigationel Site

Krakow, 30-149, Poland

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Leo Pharma Investigationel Site

Krakow, 31-011, Poland

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Leo Pharma Investigationel Site

Lodz, 90-265, Poland

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Leo Pharma Investigationel Site

Lodz, 90-436, Poland

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Leo Pharma Investigationel Site

Rzeszów, 35-055, Poland

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Leo Pharma Investigationel Site

Świdnik, 21-040, Poland

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Leo Pharma Investigationel Site

Wroclaw, 50-001, Poland

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Leo Pharma Investigationel Site

Wroclaw, 51-318, Poland

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Leo Pharma Investigationel Site

Wroclaw, 52-416, Poland

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Leo Pharma Investigationel Site

Glasgow, G51 4TF, United Kingdom

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Leo Pharma Investigationel Site

London, E11 1NR, United Kingdom

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Related Publications (4)

• 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.

  PMID: 37074705 RESULT

• 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.

  PMID: 40721559 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

• 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.

  PMID: 35671038 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 Specialist
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 44945888

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 healthcare 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: May 4, 2018
• First Posted: May 16, 2018
• Study Start: June 19, 2018
• Primary Completion: April 15, 2020
• Study Completion: March 16, 2021
• Last Updated: March 11, 2025
• Results First Posted: October 29, 2021

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); PL (10); CA (11); DE (4); GB (2); JP (14); NL (4); US (29); BE (4); FR (5)