Evidence map›Paper›PMID 33000465›Full record

Trial reportThe British journal of dermatology2021

Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2).

A Wollenberg, A Blauvelt, E Guttman-Yassky, M Worm, C Lynde, J-P Lacour, L Spelman, N Katoh, H Saeki, Y Poulin and 13 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The British journal of dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 288 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
288citing papers in PubMed, 7 pooled it
42.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03131648 phase3completednot on this map

A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

TypeinterventionalSponsorLEO PharmaRan2017 to 2019Enrolled802ConditionsAtopic DermatitisArmsTralokinumab, Placebo
NCT03160885 phase3completednot on this map

A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

TypeinterventionalSponsorLEO PharmaRan2017 to 2019Enrolled794ConditionsAtopic DermatitisArmsTralokinumab, Placebo
NCT06773455 phase4terminatednot on this mapstarted 2023, after this paper: background citation

A Single-Center, Open-Label Study to Evaluate Tralokinumab in Atopic Dermatitis Subjects Who Experienced Inadequate Response on Dupilumab

TypeinterventionalSponsorPsoriasis Treatment Center of Central New JerseyRan2023 to 2026Enrolled7ConditionsAtopic DermatitisArmstralokinumab
3 · Its place in the literature

Who cites it

288 citing papers in PubMed, 7 syntheses or guidelines pooled it, 563 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. European Guideline (EuroGuiDerm) on atopic eczema: Living update.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
    Guideline
  4. European S2k Guideline on Chronic PruritusActa dermato-venereologica · 2025
    Guideline
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Efficacy of up to 4 years of tralokinumab in adults with moderate-to-severe atopic dermatitis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Trial
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  13. Improvement and maintenance of clinical outcome assessments in atopic dermatitis with amlitelimab.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
    Trial
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228 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 18 institutions in 12 countries.

A WollenbergDepartment of Dermatology and Allergy, Ludwig Maximilian University of Munich, Munich, Germany.ORCID 0000-0003-0177-8722
A BlauveltOregon Medical Research Center, Portland, OR, USA.ORCID 0000-0002-2633-985X
E Guttman-YasskyDepartment of Dermatology and the Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0002-9363-324X
M WormDivision of Allergy and Immunology, Department of Dermatology, Venereology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0002-3449-1245
C LyndeLynde Dermatology, Probity Medical Research, Markham, ON, Canada.
J-P LacourDepartment of Dermatology, University Hospital of Nice, Nice, France.ORCID 0000-0001-7663-2053
L SpelmanVeracity Clinical Research, Brisbane, QLD, Australia.ORCID 0000-0002-7330-4713
N KatohDepartment of Dermatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.ORCID 0000-0002-3498-2482
H SaekiDepartment of Dermatology, Nippon Medical School, Tokyo, Japan.ORCID 0000-0002-1095-0355
Y PoulinLaval University and Centre Dermatologique du Québec Métropolitain and Centre de Recherche Dermatologique du Québec Métropolitain, Québec, QC, Canada.
A LesiakDepartment of Dermatology and Pediatric and Oncologic Dermatology, Medical University of Łódź, Łódź, Poland.
L KircikIcahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0002-0831-2151
S H ChoDepartment of Dermatology, The Catholic University of Korea, Seoul, South Korea.
P HerranzDepartment of Dermatology, Hospital Universitario La Paz, Madrid, Spain.ORCID 0000-0002-9840-6628
M J CorkSheffield Dermatology Research, Department of Infection, Immunity, and Cardiovascular Disease, The University of Sheffield and Sheffield Teaching Hospitals NIHR Clinical Research Facility, Sheffield, UK.ORCID 0000-0003-4428-2428
K PerisDermatology, Catholic University and Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.ORCID 0000-0002-5237-0463
L A SteffensenLEO Pharma A/S, Ballerup, Denmark.ORCID 0000-0003-4337-4945
B BangLEO Pharma A/S, Ballerup, Denmark.ORCID 0000-0003-1837-3393
A KuznetsovaLEO Pharma A/S, Ballerup, Denmark.
T N JensenLEO Pharma A/S, Ballerup, Denmark.
M L ØsterdalLEO Pharma A/S, Ballerup, Denmark.
E L SimpsonDepartment of Dermatology, Oregon Health & Science University, Portland, OR, USA.
ECZTRA 1 and ECZTRA 2 study investigators
Leo Pharma (Denmark) · DKAgostino Gemelli University Polyclinic · ITCatholic University of Korea · KRCentre de Recherche Dermatologique du Québec Métropolitain · CACentre Hospitalier Universitaire de Nice · FRCharité - Universitätsmedizin Berlin · DEHospital Universitario La Paz · ESIcahn School of Medicine at Mount Sinai · USKyoto Prefectural University of Medicine · JPLudwig-Maximilians-Universität München · DEMedical University of Lodz · PLNippon Medical School · JPOregon Health & Science University · USOregon Medical Research Center · USUniversity Medical Center · USUniversity of Sheffield · GBUniversity of Toronto · CAVeracity Clinical Research · AU

Funding

LEO Pharma A/S
6 · The paper itself

Abstract

backgroundTralokinumab, a fully human monoclonal antibody, specifically neutralizes interleukin-13, a key cytokine driving peripheral inflammation in atopic dermatitis (AD). In phase II studies, tralokinumab combined with topical corticosteroids provided early and sustained improvements in AD signs and symptoms.

objectivesTo evaluate the efficacy and safety of tralokinumab monotherapy in adults with moderate-to-severe AD who had an inadequate response to topical treatments.

methodsIn two 52-week, randomized, double-blind, placebo-controlled, phase III trials, ECZTRA 1 and ECZTRA 2, adults with moderate-to-severe AD were randomized (3 : 1) to subcutaneous tralokinumab 300 mg every 2 weeks (Q2W) or placebo. Primary endpoints were Investigator's Global Assessment (IGA) score of 0 or 1 at week 16 and ≥ 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16. Patients achieving an IGA score of 0 or 1 and/or EASI 75 with tralokinumab at week 16 were rerandomized to tralokinumab Q2W or every 4 weeks or placebo, for 36 weeks. The trials were registered with ClinicalTrials.gov: NCT03131648 and NCT03160885.

resultsAt week 16, more patients who received tralokinumab vs. placebo achieved an IGA score of 0 or 1: 15·8% vs. 7·1% in ECZTRA 1 [difference 8·6%, 95% confidence interval (CI) 4·1-13·1; P = 0·002] and 22·2% vs. 10·9% in ECZTRA 2 (11·1%, 95% CI 5·8-16·4; P < 0·001) and EASI 75: 25·0% vs. 12·7% (12·1%, 95% CI 6·5-17·7; P < 0·001) and 33·2% vs. 11·4% (21·6%, 95% CI 15·8-27·3; P < 0·001). Early improvements in pruritus, sleep interference, Dermatology Life Quality Index, SCORing Atopic Dermatitis and Patient-Oriented Eczema Measure were observed from the first postbaseline measurements. The majority of week 16 tralokinumab responders maintained response at week 52 with continued tralokinumab treatment without any rescue medication (including topical corticosteroids). Adverse events were reported in 76·4% and 61·5% of patients receiving tralokinumab in ECZTRA 1 and ECZTRA 2, respectively, and in 77·0% and 66·0% of patients receiving placebo in ECZTRA 1 and ECZTRA 2, respectively, in the 16-week initial period.

conclusionsTralokinumab monotherapy was superior to placebo at 16 weeks of treatment and was well tolerated up to 52 weeks of treatment.

Indexed as

Dermatitis, AtopicEczemaAdultAntibodies, MonoclonalDouble-Blind MethodHumansSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonaltralokinumab

Identifiers

PMID33000465
PMCPMC7986411
OpenAlexW3091046625

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.