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

A Phase 3 study testing Tralokinumab in people with Atopic Dermatitis, run by LEO Pharma at 87 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: Tralokinumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 301 participants
Where: 87 sitesin 10 countries
Study dates: 19 Jun 2018to 16 Mar 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

87 sites in 10 countries.

Country

City, postcode or hospital

87 sites in 10 countries

United States29 sites

Leo Pharma Investigational Site
Albany, Georgia, 31707
LEO Pharma Investigational Site
Ann Arbor, Michigan, 48103
LEO Pharma Investigational Site
Austin, Texas, 78746
LEO Pharma Investigational Site
Baton Rouge, Louisiana, 70808
LEO Pharma Investigational Site
Bexley, Ohio, 43209
LEO Pharma Investigational Site
Birmingham, Alabama, 35209
LEO Pharma Investigational Site
Chicago, Illinois, 60611
LEO Pharma Investigational Site
Corning, New York, 14830
LEO Pharma Investigational Site
East Windsor, New Jersey, 08520
LEO Pharma Investigational Site
Fort Smith, Arkansas, 72916
Leo Pharma Investigational Site
Fountain Valley, California, 92708
LEO Pharma Investigational Site
High Point, North Carolina, 27262
LEO Pharma Investigational Site
Houston, Texas, 77030
LEO Pharma Investigational Site
Los Angeles, California, 90045
LEO Pharma Investigational Site
Louisville, Kentucky, 40215
LEO Pharma Investigational Site
Miami, Florida, 33137
LEO Pharma Investigational Site
Minneapolis, Minnesota, 55402
Leo Pharma Investigational Site
Murfreesboro, Tennessee, 37130
LEO Pharma Investigational Site
New Haven, Connecticut, 06520-8059
Leo Pharma Investigational Site
New York, New York, 10075
Leo Pharma Investigational Site
North Charleston, South Carolina, 29420
LEO Pharma Investigational Site
Philadelphia, Pennsylvania, 19104
LEO Pharma Investigational Site
Portland, Oregon, 97223
LEO Pharma Investigational Site
Portland, Oregon, 97239
Leo Pharma Investigational Site
San Antonio, Texas, 78218
LEO Pharma Investigational Site
San Francisco, California, 94132
LEO Pharma Investigational Site
Stanford, California, 94304
Leo Pharma Investigational Site
Tulsa, Oklahoma, 74136
LEO Pharma Investigational Site
Ypsilanti, Michigan, 48197

Other trials in United States

Japan14 sites

Leo Pharma Investigationel Site
Fukuoka, 814-0180
Leo Pharma Investigationel Site
Kagoshima, 890-8520
Leo Pharma Investigationel Site
Kyoto, 602-8566
Leo Pharma Investigationel Site
Nagoya, 457-8510
Leo Pharma Investigationel Site
Obihiro, 080-0013
Leo Pharma Investigationel Site
Osaka, 593-8324
Leo Pharma Investigationel Site
Osaka-fu, 560-0085
Leo Pharma Investigationel Site
Shimotsuke, 329-0498
Leo Pharma Investigationel Site
Tokyo, 136-0074
Leo Pharma Investigationel Site
Tokyo, 141-8625
Leo Pharma Investigationel Site
Tokyo, 169-0075
Leo Pharma Investigationel Site
Tokyo, 171-0022
Leo Pharma Investigationel Site
Tsu, 514-8507
Leo Pharma Investigationel Site
Yamanashi, 400-8506

Other trials in Japan

Canada11 sites

LEO Pharma Investigational Site
Calgary, Alberta, T3A 2N1
LEO Pharma Investigational Site
Edmonton, Alberta, T6G 1C9
LEO Pharma Investigational Site
Markham, Ontario, L3P 1X2
LEO Pharma Investigational Site
Montreal, Quebec, H3T 1C5
LEO Pharma Investigational Site
Oakville, Ontario, L6J 7W5
LEO Pharma Investigational Site
Saskatoon, Saskatchewan, S7K 0H6
LEO Pharma Investigational Site
Surrey, British Columbia, V3R 6A7
LEO Pharma Investigational Site
Toronto, Ontario, M5A 3R6
LEO Pharma Investigational Site
Windsor, Ontario, N8X 2G1
LEO Pharma Investigational Site
Winnipeg, Manitoba, R3C 1T6
LEO Pharma Investigational Site
Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Poland10 sites

Leo Pharma Investigationel Site
Krakow, 30-033
Leo Pharma Investigationel Site
Krakow, 30-149
Leo Pharma Investigationel Site
Krakow, 31-011
Leo Pharma Investigationel Site
Lodz, 90-265
Leo Pharma Investigationel Site
Lodz, 90-436
Leo Pharma Investigationel Site
Rzeszów, 35-055
Leo Pharma Investigationel Site
Świdnik, 21-040
Leo Pharma Investigationel Site
Wroclaw, 50-001
Leo Pharma Investigationel Site
Wroclaw, 51-318
Leo Pharma Investigationel Site
Wroclaw, 52-416

Other trials in Poland

France5 sites

Leo Pharma Investigationel Site
Marseille, 13285
Leo Pharma Investigationel Site
Nice, 06200
Leo Pharma Investigationel Site
Paris, 75015
Leo Pharma Investigationel Site
Paris, 75020
Leo Pharma Investigationel Site
Valence, 26000

Other trials in France

Australia4 sites

Leo Pharma Investigationel Site
Darlinghurst, 2010
Leo Pharma Investigationel Site
Kogarah, 2217
Leo Pharma Investigationel Site
Melbourne, 3002
Leo Pharma Investigationel Site
Woolloongabba, 4102

Other trials in Australia

Belgium4 sites

Leo Pharma Investigationel Site
Brussels, 1200
Leo Pharma Investigationel Site
Ghent, B-9000
Leo Pharma Investigationel Site
Liège, 4000
Leo Pharma Investigational Site
Maldegem, 9990

Other trials in Belgium

Germany4 sites

Leo Pharma Investigationel Site
Berlin, 10115
Leo Pharma Investigationel Site
Dresden, 01307
Leo Pharma Investigationel Site
Jena, 49074
Leo Pharma Investigationel Site
Osnabrück, 49074

Other trials in Germany

Netherlands4 sites

Leo Pharma Investigationel Site
Bergen op Zoom, 4708
Leo Pharma Investigationel Site
Breda, 4818
Leo Pharma Investigationel Site
Groningen, 9713
Leo Pharma Investigationel Site
Rotterdam, 3015

Other trials in Netherlands

United Kingdom2 sites

Leo Pharma Investigationel Site
Glasgow, G51 4TF
Leo Pharma Investigationel Site
London, E11 1NR

Other trials in United Kingdom

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy

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
Being tested: Tralokinumab, Placebos
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TralokinumabDrug
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.
PlacebosDrug
Also called Placebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.

Study groups in NCT03526861
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Tralokinumab; Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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
The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.
Measured: At Week 16
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Measured: From Week 0 to Week 16
Change in Children's Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16
The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Measured: From Week 0 to Week 16
Number of Adverse Events
Number of AEs during the Initial treatment period is presented. For a summary of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the initial treatment period, maintenance treatment period, open-label treatment period, and safety follow-up period, see the Adverse Events Overview section.
Measured: From Week 0 to Week 16
Presence of Anti-drug Antibodies
Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.
Measured: From Week 0 to Week 16
Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) 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.
Measured: At Week 16
Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) 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.
Measured: At Week 16
Change in Eczema Area and Severity Index (EASI) Score From Baseline to 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.
Measured: From Week 0 to Week 16
Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16
The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.
Measured: At Week 16
Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16
The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.
Measured: At Week 16
Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16
The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.
Measured: From Week 0 to Week 16
Participants With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16
The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.
Measured: At Week 16
Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16
The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6' days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
Measured: From Week 0 to Week 16
Tralokinumab Serum Trough Concentration at Week 16
Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.
Measured: At Week 16
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to 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).
Measured: At Week 52
Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to 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.
Measured: At Week 52
Tralokinumab Serum Trough Concentration at Week 66
Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.
Measured: At Week 66

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jun 201816 Mar 2021

First posted16 May 2018
Study start19 Jun 2018
Primary completion15 Apr 2020
Study completion16 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03526861
Sponsor's protocol ID: LP0162-1334
Other IDs: 2017-005143-33, 2017
Status last verified: May 2023
First submitted: 4 May 2018
Last updated: 11 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37074705
Paller AS, Cork MJ, Hong HC, Soong W, Schneider SKR, Lo H, Vinther F, Thogersen P, Wollenberg A. Clinical Laboratory Parameters in Adolescents with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab Up to Week 52 in the Phase 3 ECZTRA 6 Trial. Dermatol Ther (Heidelb). 2026 Jun;16(6):3037-3048. doi: 10.1007/s13555-026-01745-7. Epub 2026 Apr 25.
PubMed 42033591
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.
PubMed 40721559
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.
PubMed 40555305
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.
PubMed 35671038

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy
ClinicalTrials.gov ID: NCT03526861
Acronym / sponsor ID: LP0162-1334
Conditions: Atopic Dermatitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: 19 Jun 2018 (actual)
Primary completion: 15 Apr 2020 (actual)
Study completion: 16 Mar 2021 (actual)
First posted: 16 May 2018 (actual)
Results: Posted 29 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceA	Experimental	Drug: TralokinumabWeek 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(Dose1) initial-> Tralokinumab(Dose1) maintenanceB	Experimental	Drug: TralokinumabWeek 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(Dose2) initial-> Tralokinumab(Dose2) maintenanceA	Experimental	Drug: TralokinumabWeek 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(Dose2) initial-> Tralokinumab(Dose2) maintenanceB	Experimental	Drug: TralokinumabWeek 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.
Placebo initial-> Placebo maintenance	Experimental	Drug: PlacebosWeek 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.
Tralokinumab (Dose1) initial-> Open-label tralokinumab	Experimental	Drug: TralokinumabWeek 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 (Dose2) initial-> Open-label tralokinumab	Experimental	Drug: TralokinumabWeek 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
Placebo initial-> Open-label tralokinumab	Experimental	Drug: Tralokinumab, Drug: PlacebosWeek 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

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TralokinumabTralokinumab 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.	Drug	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
PlacebosAlso: PlaceboPlacebo contains the same excipients in the same concentration only lacking tralokinumab.	Drug	Placebo initial-> Open-label tralokinumab, Placebo initial-> Placebo maintenance

Primary outcome

Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
Time frame: 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).
Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
Time frame: 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.

17 secondary outcomes

Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16
Time frame: At Week 16
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16
Time frame: From Week 0 to Week 16
Change in Children's Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16
Time frame: From Week 0 to Week 16
Number of Adverse Events
Time frame: From Week 0 to Week 16
Presence of Anti-drug Antibodies
Time frame: From Week 0 to Week 16
Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.
Time frame: At Week 16
Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.
Time frame: At Week 16
Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16
Time frame: From Week 0 to Week 16
Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16
Time frame: At Week 16
Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16
Time frame: At Week 16
Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16
Time frame: From Week 0 to Week 16
Participants With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16
Time frame: At Week 16
Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16
Time frame: From Week 0 to Week 16
Tralokinumab Serum Trough Concentration at Week 16
Time frame: At Week 16
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16
Time frame: At Week 52
Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16
Time frame: At Week 52
Tralokinumab Serum Trough Concentration at Week 66
Time frame: At Week 66

Results and safety

Results posted to the registry on 29 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Initial Treatment Period - Tralokinumab 300 mg Q2W	101	94
Initial Treatment Period - Tralokinumab 150 mg Q2W	100	93
Initial Treatment Period - Placebo	100	86
Maintenance Treatment Period - Tralokinumab 300 mg Q2W	0	0
Maintenance Treatment Period - Tralokinumab 300 mg Q4W	0	0
Maintenance Treatment Period - Tralokinumab 150 mg Q2W	0	0
Maintenance Treatment Period - Tralokinumab 150 mg Q4W	0	0
Maintenance Treatment Period - Placebo Q2W	0	0
Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS	0	0

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

Time frame: At Week 16. Count of participants. Unit: Participants

Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n = 97	Initial Treatment Period - Tralokinumab 150 mg Q2W n = 98	Initial Treatment Period - Placebo n = 94
Value	17	21	4

Initial Treatment Period - Tralokinumab 300 mg Q2W vs Initial Treatment Period - Placebo: Risk Difference (RD): 13.8 (95% CI 5.3 to 22.3), p = 0.002, Cochran-Mantel-Haenszel
Initial Treatment Period - Tralokinumab 150 mg Q2W vs Initial Treatment Period - Placebo: Risk Difference (RD): 17.5 (95% CI 8.4 to 26.6), p <0.001, Cochran-Mantel-Haenszel

Population analysed: The full analysis set (FAS: All subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified) was used for the primary analysis.

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

Time frame: At Week 16. Count of participants. Unit: Participants

Measure	Initial Treatment Period - Tralokinumab 300 mg Q2W n = 97	Initial Treatment Period - Tralokinumab 150 mg Q2W n = 98	Initial Treatment Period - Placebo n = 94
Value	27	28	6

Initial Treatment Period - Tralokinumab 300 mg Q2W vs Initial Treatment Period - Placebo: Risk Difference (RD): 22.0 (95% CI 12.0 to 32.0), p <0.001, Cochran-Mantel-Haenszel
Initial Treatment Period - Tralokinumab 150 mg Q2W vs Initial Treatment Period - Placebo: Risk Difference (RD): 22.5 (95% CI 12.4 to 32.6), p <0.001, Cochran-Mantel-Haenszel

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Initial Treatment Period - Tralokinumab 300 Q2W	1 of 97 (1%)	44 of 97 (45.4%)	0 of 97
Initial Treatment Period - Tralokinumab 150 Q2W	3 of 98 (3.1%)	47 of 98 (48%)	0 of 98
Initial Treatment Period - Placebo	5 of 94 (5.3%)	36 of 94 (38.3%)	0 of 94
Maintenance Treatment Period - Tralokinumab 300 Q2W	0 of 11 (0%)	7 of 11 (63.6%)	0 of 11
Maintenance Treatment Period - Tralokinumab 300 Q4W	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13
Maintenance Treatment Period - Tralokinumab 150 Q2W	0 of 12 (0%)	7 of 12 (58.3%)	0 of 12
Maintenance Treatment Period - Tralokinumab 150 Q4W	0 of 14 (0%)	8 of 14 (57.1%)	0 of 14
Maintenance Treatment Period - Placebo	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Open-label Treatment - Tralokinumab 300 Q2W + Optional TCS	7 of 234 (3%)	100 of 234 (42.7%)	0 of 234
Safety Follow-up	3 of 234 (1.3%)	16 of 234 (6.8%)	0 of 234

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37074705Paller 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.
Derived from this study: PubMed 42033591Paller AS, Cork MJ, Hong HC, Soong W, Schneider SKR, Lo H, Vinther F, Thogersen P, Wollenberg A. Clinical Laboratory Parameters in Adolescents with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab Up to Week 52 in the Phase 3 ECZTRA 6 Trial. Dermatol Ther (Heidelb). 2026 Jun;16(6):3037-3048. doi: 10.1007/s13555-026-01745-7. Epub 2026 Apr 25.
Derived from this study: PubMed 40721559Paller 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.
Derived from this study: PubMed 40555305Paller 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.
Derived from this study: PubMed 35671038Soehoel 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.
Individual participant dataSharing planned: No

Related trials for Atopic Dermatitis

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical expert study director

LEO Pharma

87 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tralokinumab in people with Atopic Dermatitis, run by LEO Pharma at 87 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Japan, Canada, Poland, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 (time frame: At Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03526861, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.