AzTrials
AzTrials

Atopic DermatitisPhase 3NCT03363854

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

A Phase 3 study testing Tralokinumab in people with Atopic Dermatitis, run by LEO Pharma at 66 sites in 8 countries.

Completed

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

Official record
Search all trials

Trial summary

Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD). Read more about this study

Who is it for?
Ages 18 years and older
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
380 participants
Where
66 sitesin 8 countries
Study dates
22 Feb 2018to 26 Sep 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Subjects for whom TCS are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator.
  • Active dermatologic conditions that may confound the diagnosis of AD.
  • Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
  • Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
  • Treatment with TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
  • Receipt of any marketed biological therapy (i.e. immunoglobulin, anti- immunoglobulin E) including dupilumab or investigational biologic agents within 3 months or 5 half-lives, whichever is longer prior to randomisation.
Show all 11Show fewer
  • 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.

Trial locations and contacts

66 sites in 8 countries.

66 sites in 8 countries

United States21 sites

  • Medical Dermatology Specialists

    Atlanta, Georgia, 30328

  • Study Center

    Bangor, Maine, 04401

  • Dermatologists of Greater Columbus

    Bexley, Ohio, 43209

  • University of Alabama-Birmingham

    Birmingham, Alabama, 35233

  • Northwestern University

    Chicago, Illinois, 60611

  • Danbury Clinical Research

    Danbury, Connecticut, 06810

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Center for Dermatology Clinical Research

    Fremont, California, 94538

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • International Dermatology Research

    Miami, Florida, 33144

  • L & C Professional Medical Research

    Miami, Florida, 33144

  • Mount Sinai West Dermatoogy

    New York, New York, 10023

  • National Allergy and Asthma Research, LLC

    North Charleston, South Carolina, 29420

  • Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Oregon Dermatology & Research

    Portland, Oregon, 97210

  • Wake Research

    Raleigh, North Carolina, 27612

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Lenus Research & Medical Group

    Sweetwater, Florida, 33172

  • Olympian Clinical Research

    Tampa, Florida, 33614

  • Respiratory Medicine Research

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada10 sites

  • CCA Medical Research

    Ajax, Ontario, L1S 7K8

  • Simcoderm Medical and Surgical Dermatology Centre

    Barrie, Ontario, L4M 6L2

  • Maritime Medical Research Centre

    Bathurst, New Brunswick, E2A 4Z9

  • Institute for Skin Advancement

    Calgary, Alberta, T3A 2N1

  • Eastern Canada Cutaneous Research

    Halifax, Nova Scotia, B3H 1Z4

  • DermEdge Research

    Mississauga, Ontario, L5H 1G9

  • York Dermatology Center

    Richmond Hill, Ontario, L4C 9M7

  • Research Toronto

    Toronto, Ontario, M4W 2N2

  • Skin Care Centre

    Vancouver, British Columbia, V5Z 4E8

  • XLR8 Medical Research

    Windsor, Ontario, N8W 1E6

Other trials in Canada

Germany8 sites

  • Interdisciplinary Study Association GmbH

    Berlin, 10780

  • St. Josef-Hospital, Ruhr-Universitet

    Bochum, 44791

  • Klinik und Poliklinik für Dermatologie und Allergologie

    Bonn, 53105

  • Klinikum der Johann Wolfgang Goethe-Universität Klinik

    Frankfurt am Main, 60590

  • MensingDerma Research GmbH

    Hamburg, 22391

  • Universitätsklinikum Jena

    Jena, 07743

  • Universitätshautklinik Kiel

    Kiel, 24105

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

United Kingdom7 sites

  • Queen Elizabeth Hospital Birmingham

    Birmingham, West Midlands, B15 2TH

  • Addenbooke's Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • Russells Hall Hospital

    Dudley, West Midlands, DY1 2HQ

  • The Princess Alexandra Hospital

    Harlow, Essex, CM20 1QX

  • The Royal Free Hospital

    London, NW3 2QG

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT

  • East Surrey Hospital

    Redhill, Surrey, RH1 5RH

Other trials in United Kingdom

Netherlands6 sites

  • Amcademic Medical Center

    Amsterdam, 1105 AZ

  • LEO Pharma Investigational Site

    Bergen op Zoom, 4614 VT

  • LEO Pharma Investigational Site

    Groningen, 9713 GZ

  • Radboud MC

    Nijmegen, 6525

  • Erasmus MC, Rotterdam

    Rotterdam, 3015 CA

  • University Medical Centre Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Poland5 sites

  • Nzoz Med-Laser

    Lublin, 20-146

  • LEO Pharma Investigational Site

    Rzeszów, 35-055

  • Wojskowy Instytut Medyczny

    Warsaw, 01-0141

  • Wromedica s.c.

    Wroclaw, 50-001

  • Derm Medica Sp.zo.o.

    Wroclaw, 51-318

Other trials in Poland

Spain5 sites

  • Hospital General de Alicante

    Alicante, 03010

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Fundación Hospital Alcorcón

    Madrid, 28922

  • Hospital de Pontevedra

    Pontevedra, 36003

  • Hospital General de Valencia

    Valencia, 46014

Other trials in Spain

Belgium4 sites

  • University Hospital Antwerp

    Antwerp, 2650

  • Universitair ziekenhuis Brussel

    Brussels, 1090

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • LEO Pharma Investigational Site

    Loverval, 6280

Other trials in Belgium

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Subjects With Moderate to Severe Atopic Dermatitis

Primary objective:

To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).

Secondary objectives:

To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared with placebo in combination with TCS.

To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.

Being tested
Tralokinumab, Placebo
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 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.

  • PlaceboDrug

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

Study groups in NCT03363854
Study groupRoleWhat they receive
Tralokinumab(initial)responders-> Tralokinumab(continuation A)ExperimentalWeek 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.
Receives: Drug: Tralokinumab
Tralokinumab(initial)responders-> Tralokinumab(continuation B)ExperimentalWeek 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.
Receives: Drug: Tralokinumab
Tralokinumab(initial)non-respon-> Tralokinumab(continuation A)ExperimentalWeek 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.
Receives: Drug: Tralokinumab
Placebo (initial)non-respon-> Tralokinumab(continuation A)ExperimentalWeek 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.
Receives: Drug: Tralokinumab; Drug: Placebo
Placebo(initial)responders-> Placebo(continuation A)Placebo comparatorWeek 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.
Receives: Drug: Placebo

What is being measured

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

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

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

    Measured: Week 16

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

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

    Measured: Week 16

Secondary outcomes (17)

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

    Worst Daily Pruritus NRS is used by the participant to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable') on an 11-point scale.

    Measured: Week 0 to Week 16

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

    SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.

    Measured: Week 0 to Week 16

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

    DLQI is used by the participant to evaluate the impact of their condition on 10 different aspects of health-related quality of life (HRQoL) over the last week. Each item is scored on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much). The total score which is the sum of the 10 items ranges from 0 to 30, with a higher score indicating a poorer HRQoL.

    Measured: Week 0 to Week 16

  4. Frequency of Anti-drug Antibodies (ADA)

    Presence of ADA from Week 0 to Week 32 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment. Perishing ADAs were not assessed in the continuation treatment period.

    Measured: Week 0 to Week 16, Week 16 to Week 32

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

    Assessed as the amount of TCS weighed from previous visits, assuming no TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits.

    Measured: Week 1-2 to Week 15-16

  6. Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes

    Assessed as the amount of TCS weighed from previous visits, assuming all TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits.

    Measured: Week 1-2 to Week 15-16

  7. Number of Atopic Dermatitis Flares Through Week 16

    Assessed as appearance of new flares since previous visit.

    Measured: Week 0 to Week 16

  8. Number of Days Without Topical Treatment Use From Baseline to Week 16

    Participants assessed their use of topical treatment over the past 24 hours using a response scale ('yes', 'no'). Measurements of number of days per week were used in the analysis.

    Measured: Week 1 to Week 16

  9. Participants Achieving at Least 50% Reduction in Eczema Area and Severity Index (EASI) at Week 16

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

    Measured: Week 16

  10. Participants Achieving at Least 90% Reduction in Eczema Area and Severity Index (EASI) at Week 16

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

    Measured: Week 16

  11. Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score

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

    Measured: Week 0 to Week 16

  12. Participants Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16

    SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.

    Measured: Week 16

  13. Participants Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16

    SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.

    Measured: Week 16

  14. Change From Baseline to Week 16 in Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average)

    Worst Daily Pruritus NRS is used by the participant to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable') on an 11-point scale.

    Measured: Week 0 to Week 16

  15. Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of at Least 4 Points Among Participants With Baseline DLQI ≥4

    DLQI is used by the participant to evaluate the impact of their condition on 10 different aspects of health-related quality of life (HRQoL) over the last week. Each item is scored on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much). The total score which is the sum of the 10 items ranges from 0 to 30, with a higher score indicating a poorer HRQoL.

    Measured: Week 0 to Week 16

  16. Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 32 Among Participants With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab

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

    Measured: Week 32

  17. Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 32 Among Participants Who Had Achieved at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab

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

    Measured: Week 32

Timeline

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

  1. First posted6 Dec 2017
  2. Study start22 Feb 2018
  3. Primary completion8 Mar 2019
  4. Study completion26 Sep 2019

Resources

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
380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03363854
Sponsor's protocol ID
LP0162-1339
Other IDs
2017-002065-21, 2017
Status last verified
Feb 2021
First submitted
1 Dec 2017
Last updated
11 Mar 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. 2026 Jan;27(1):149-166. doi: 10.1007/s40257-025-00985-1. Epub 2025 Oct 21.

    PubMed 41118053

  • 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). 2026 Jan;16(1):265-276. doi: 10.1007/s13555-025-01565-1. Epub 2025 Oct 16.

    PubMed 41102518

  • 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

  • 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.

    PubMed 36152216

  • 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.

    PubMed 35857179

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 66 sites in 8 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 11 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 66 sites in United States, Canada, Germany, United Kingdom, Netherlands and 3 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. Some participants in this study may receive a placebo. 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 14 Jan 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?

Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 (time frame: 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 NCT03363854, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in