AzTrials
AzTrials

Atopic DermatitisPhase 3ECZTRA 1NCT03131648

Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)

A Phase 3 study testing Tralokinumab in people with Atopic Dermatitis, run by LEO Pharma at 123 sites in 5 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 evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (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. 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
802 participants
Where
123 sitesin 5 countries
Study dates
30 May 2017to 10 Oct 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

  • Written informed consent and any locally required authorisation obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
  • Age 18 and above.
  • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD (34; Appendix 5).
  • Diagnosis of AD for ≥1 year.
  • Subjects who have a recent history (within 1 year before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g., due to important side effects or safety risks).
  • Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to IGA 0=clear to 2=mild) despite treatment with a daily regimen of TCS of medium to higher potency (±TCI as appropriate), applied for at least 28 days or for the maximum duration recommended by the product prescribing information (e.g., 14 days for super potent TCS), whichever is shorter.
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  • Subjects with documented systemic treatment for AD in the past year are also considered as inadequate responders to topical treatments and are potentially eligible for treatment with tralokinumab after appropriate washout.
  • Important side effects or safety risks are those that outweigh the potential treatment benefits and include intolerance to treatment, hypersensitivity reactions, significant skin atrophy, and systemic effects, as assessed by the investigator or by the subject's treating physician.
  • AD involvement of ≥10% body surface area at screening and baseline (visit 3).
  • An EASI score of ≥12 at screening and 16 at baseline.
  • An IGA score of ≥3 at screening and at baseline.
  • A Worst Daily Pruritus numeric rating scale (NRS) average score of ≥4 during the week prior to baseline.
  • Worst Daily Pruritus NRS at baseline will be calculated from daily assessments of worst itch severity (Worst Daily Pruritus NRS) during the 7 days immediately preceding randomisation (Day 6 to 0). A minimum of 4 Worst Daily Pruritus NRS scores out of the 7 days is required to calculate the baseline average score. For subjects who do not have at least 4 scores reported during the 7 days immediately preceding the planned randomisation date, randomisation should be postponed until this requirement is met, but without exceeding the 6 weeks maximum duration for screening.
  • Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation (refer to exclusion criterion no. 8 for limitations regarding emollients).
  • Women of childbearing potential must use a highly effective* form of birth control (confirmed by the investigator) throughout the trial and at least for 16 weeks (5 half lives) after last administration of IMP.
  • A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as bilateral tubal occlusion, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), sexual abstinence (when this is in line with the preferred and usual life style of the subject), vasectomised partner (given that the subject is monogamous). The subjects must have used the contraceptive method continuously for at least 1 month prior to the pregnancy test at baseline. A female is defined as not being of child-bearing potential if she is postmenopausal (at least 12 months with no menses without an alternative medical cause prior to screening), or surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy).

Who cannot join

  • Concurrent enrolment in another clinical trial where the subject is receiving an IMP.
  • Previous randomisation in tralokinumab trials.
  • Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, or psoriasis.
  • Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
  • Use of tanning beds or phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), within 6 weeks prior to randomisation.
  • Treatment with the following medications within 4 weeks prior to randomisation:
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  • Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, Janus kinase inhibitors etc.).
  • Systemic corticosteroid use (excludes topical, inhaled, or intranasal delivery).
  • Three or more bleach baths during any week within the 4 weeks.
  • Treatment with the following medications within 2 weeks prior to randomisation
  • TCS.
  • TCI.
  • Topical PDE 4 inhibitor.
  • Initiation of treatment of AD with prescription emollients or emollients containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (subjects may continue using stable doses of such emollients if initiated before the screening visit).
  • Receipt of live attenuated vaccines 30 days prior to the date of randomisation and during the trial including the safety follow-up period.
  • Receipt of inactive/killed vaccinations (e.g. inactive influenza) are allowed, provided they are not administered within 5 days before/after any study visit.
  • Receipt of any marketed (i.e. immunoglobulin, anti-IgE) or investigational biologic agent, including dupilumab:
  • Any cell-depleting agents including but not limited to rituximab: within 6 months prior to randomisation, or until lymphocyte count returns to normal, whichever is longer.
  • Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to randomisation.
  • Receipt of any investigational non-biologic agent within 5 half-lives prior to randomisation.
  • Receipt of blood products within 4 weeks prior to screening.
  • Major surgery within 8 weeks prior to screening, or planned in-patient surgery or hospitalisation during the trial period.
  • Known or suspected allergy or reaction to any component of the IMP formulation.
  • History of any active skin infection within 1 week prior to randomisation.
  • History of a clinically significant infection within 4 weeks prior to randomisation which, in the opinion of the investigator or sponsor's medical expert, may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject's ability to participate in the trial. Clinically significant infections are defined as:
  • a systemic infection.
  • a serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
  • A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy.
  • History of anaphylaxis following any biologic therapy.
  • History of immune complex disease.
  • History of cancer:
  • Subjects who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained.
  • Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained.
  • Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care.
  • History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications as determined by medical history and/or subject's verbal report.
  • History of chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the investigator.
  • History of attempted suicide or is at significant risk of suicide (either in the opinion of the investigator or defined as a "yes" to suicidal ideation questions no. 4 or 5 or answering "yes" to suicidal behaviour on the Columbia-Suicide Severity Rating Scale [C-SSRS] Screening version).
  • Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, psychiatric, or major physical impairment that is not stable, in the opinion of the investigator, and could:
  • Affect the safety of the subject throughout the trial.
  • Influence the findings of the trial or their interpretations.
  • Impede the subject's ability to complete the entire duration of trial.
  • Any clinically significant abnormal findings in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during the screening period, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the trial, or may influence the results of the trial, or the subject's ability to complete entire duration of the trial.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0 times the ULN (upper limit of normal) at screening.
  • Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb) or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb may be randomised provided they are hepatitis B vaccinated and have negative HBsAg and HBcAb.
  • Subjects who are not willing to abstain from donating blood and/or plasma from the time of informed consent and for 16 weeks (5 half-lives) after last dose of IMP.
  • Subjects who are legally institutionalised.
  • Pregnant, breastfeeding, or lactating women.
  • Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals.

Trial locations and contacts

123 sites in 5 countries.

123 sites in 5 countries

United States44 sites

  • Georgia Pollens Clinical Research Centers, Inc.

    Albany, Georgia, 31707

  • Altman Dermatology Associates

    Arlington Heights, Illinois, 60005

  • Austin Dermatology Associates

    Austin, Texas, 78705

  • Tekton Research

    Austin, Texas, 78745

  • Dermatologists of Greater Columbus

    Bexley, Ohio, 43209

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35209

  • Skin Care Research, Inc.

    Boca Raton, Florida, 33486

  • University at Buffalo Department of Dermatology

    Buffalo, New York, 14203

  • PMG Research of Christie Clinic

    Chicago, Illinois, 61820

  • Clarkston Skin Research

    Clarkston, Michigan, 48346

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Allergy Center at Brookstone Research

    Columbus, Georgia, 31904

  • Dermtology Treatment and Research Center

    Dallas, Texas, 75230

  • Deaconess Clinic

    Evansville, Indiana, 47713

  • Tien Q. Nguyen, MD, Inc.

    Fountain Valley, California, 92708

  • Deramatology Consulting Services, PLLC

    High Point, North Carolina, 27262

  • Houston Skin Associates

    Houston, Texas, 77004

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana, 70601

  • JDR Dermatology Research

    Las Vegas, Nevada, 89148

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Skin Sciences, PLLC

    Louisville, Kentucky, 40217

  • Dermatologic Surgery Specialists

    Macon, Georgia, 31217

  • West Virginia Research Institute

    Morgantown, West Virginia, 26505

  • Weil Cornell Medicine

    New York, New York, 10021

  • Juva Skin & Laser Center

    New York, New York, 10022

  • Virginia Clinical Research

    Norfolk, Virginia, 23502

  • Quest Dermatology Research

    Northridge, California, 91324

  • Dermatology Specialists, Inc.

    Oceanside, California, 92056

  • Park Avenue Dermatology

    Orange Park, Florida, 32073

  • UPMC Department of Dermatology

    Pittsburgh, Pennsylvania, 15213

  • Oregon Medical Research Center

    Portland, Oregon, 97223

  • Oregon Health & Sciences University

    Portland, Oregon, 97239

  • DermAssociates, PC

    Rockville, Maryland, 20850

  • Center for Dermatology and Laser Surgery

    Sacramento, California, 95819

  • MediSearch LLC

    Saint Joseph, Missouri, 64506

  • University Clinical Trials, Inc.

    San Diego, California, 92123

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Dermatology Associates of Seattle

    Seattle, Washington, 98101

  • Forward Clinical Trials

    Tampa, Florida, 33624

  • Derm Center

    Troy, Michigan, 48084

  • The GWU Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Center for Clinical Studies

    Webster, Texas, 77958

  • Research Institute of the Southeast, LLC

    West Palm Beach, Florida, 33401

  • ACRC Dermatology

    West Palm Beach, Florida, 33406

Other trials in United States

Japan29 sites

  • Asahikawa City Hospital

    Asahikawa, 070-8610

  • JR Sapporo Hospital

    Chūō, 060-0033

  • Medical Corporation Kojinkai

    Chūō, 060-0063

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Kurume University Hospital

    Fukuoka, 830-0011

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Gifu University Hospital

    Gifu, 315-0974

  • Osaka Habikono Medical Center

    Habikino, 583-8588

  • Hamamatsu University hospital

    Hamamatsu, 431-3192

  • Meiwa Hospital

    Hyōgo, Nishinomiya, 663-8186

  • Hyogo College Of Medicine Hospital

    Hyōgo, Nishinomiya, 663-8501

  • Ichinomiya Municipal Hospital

    Ichinomiya, 491-8558

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Kyoto Prefectural Hospital

    Kyoto, 602-8566

  • Iwate Prefectural Central Hospital

    Morioka, 020-0066

  • Chukyo Hospital

    Nagoya, 457-8510

  • Takagi Dermatological Clinic

    Obihiro

  • Gokeikai Osaka Kaisei Hospital

    Ōsaka, 532-0003

  • Osaka Hospital

    Ōsaka, 553-0003

  • KUME Clinic

    Sakai, Osaka, 593-8324

  • Jichi Medical University Hospital

    Tochigi, 329-0498

  • NTT Medical Center Tokyo

    Tokyo, Shinagawa, 141-8625

  • Tokyo Teishin Hospital

    Tokyo, 102-8798

  • The Jikei University Hospital

    Tokyo, 105-8471

  • Nippon Medical School Hospital

    Tokyo, 113-8603

  • The Fraternity Memorial Hospital

    Tokyo, 130-8587

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

  • Ogikubo Hospital

    Tokyo, 167-0035

  • Shirasaki Dermatology Clinic

    Tōyama, 933-0871

Other trials in Japan

Germany22 sites

  • Klinikum Augsburg, Klinik für Dermatologie und Allergologie

    Augsburg, Bavaria

  • Charité - Universitätsmedizin Berlin, Klinik für Dermatologie, Allergologie und Venerologie

    Berlin

  • CMB Collegium Medicum Berlin GmbH

    Berlin

  • Klinikum Bielefeld Rosenhöhe, Hautklinik

    Bielefeld, North Rhine-Westphalia

  • Niesmann, Hautzentrum im Jahrhunderthaus

    Bochum, North Rhine-Westphalia

  • Universitätsklinikum Bonn, Klinik und Poliklinik für Dermatologie und Allergologie

    Bonn, North Rhine-Westphalia

  • Klinikum Darmstadt GmbH, Hautklinik

    Darmstadt, Hessia

  • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Dermatologie

    Dresden, Saxony

  • Hautzentrum Dülmen

    Dülmen, North Rhine-Westphalia

  • Universitätsklinikum Erlangen, Hautklinik

    Erlangen, Bavaria

  • Universitätsklinikum Essen (AöR), Klinik für Dermatologie, Venerologie und Allergologie

    Essen, North Rhine-Westphalia

  • Derma-Study-Center Friedrichshafen GmbH

    Friedrichshafen, Baden-Wurttemberg

  • SRH Wald-Klinikum Gera, Klinik für klinische Studien

    Gera, Thuringia

  • Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Dermatologie und Venerologie

    Halle, Saxony-Anhalt

  • SCIderm GmbH

    Hamburg

  • Hautärzte Zentrum Hannover

    Hannover, Lower Saxony, 30159

  • Medizinische Hochschule Hannover, Klinik für Dermatologie, Allergologie und Venerologie

    Hannover, Lower Saxony

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

    Leipzig, Saxony

  • Facharztpraxis für Dermatologie, Allergologie, Venerologie und Umweltmedizin

    Mahlow, Brandenburg

  • LMU München, Klinik und Poliklinik für Dermatologie und Allergologie

    München, Bavaria

  • Universitätsklinikum Münster Klinik und Poliklinik für Hautkrankheiten Münster, Zentrale Studienkoordination für innovative Dermatologie

    Münster, North Rhine-Westphalia

  • KliFOs - Klinische Forschung Osnabrück

    Osnabrück, Lower Saxony

Other trials in Germany

France14 sites

  • Hôpital St ANDRE, CHU de BORDEAUX, Service de Dermatologie

    Bordeaux

  • CHRU de Brest - Hôpital Morvan, Service de Dermatologie

    Brest

  • CHU de Dijon, Service de Dermatologie

    Dijon

  • Hôpital Claude Huriez-CHRU, Service de dermatologie

    Lille

  • Hôpital Saint vincent de paul, Clinique de Dermatologie

    Lille

  • Cabinet Médical, Le Bateau Blanc-Immeuble A

    Martigues

  • GHRMSA, Service de Dermatologie

    Mulhouse, 68100

  • Centre Hospitalier Universitaire, Clinique dermatologique 7 eme nord

    Nantes

  • Hôpital de l'Archet II, Service de Dermatologie- Vénérologie

    Nice

  • Hôpital Robert Debré, Service de Dermatologie

    Reims

  • Hôpital Charles Nicolle, Clinique Dermatologique

    Rouen

  • C.H.U. de Saint-Etienne - Hôpital Nord, Service de dermatologie

    Saint-Etienne

  • CHU de Toulouse Hôpital Larrey, Service de Dermatologie

    Toulouse

  • Centre Hospitalier de Valence

    Valence, Drôme

Other trials in France

Spain14 sites

  • Hospital Germans Trias i Pujol, Servicio Dermatología

    Badalona, Catalonia

  • Hospital Clinic de Barcelona, Dermatology Department

    Barcelona, Catalonia

  • Hospital de la Santa Creu i Sant Pau, Servicio Dermatología

    Barcelona, Catalonia

  • Hospital del Mar, Servicio Dermatología

    Barcelona, Catalonia

  • Hospital de Basurto, Servicio Dermatología

    Bilbao, Basque Country

  • Hospital de Cruces, Servicio Dermatología

    Bilbao, Basque Country

  • Hospital Reina Sofía, Servicio Dermatología

    Córdoba, Andalusia

  • Hospital de Fuenlabrada, Servicio Dermatología

    Madrid

  • Hospital Infanta Leonor, Servicio Dermatología

    Madrid

  • Hospital Universitario de la Princesa, Servicio Dermatología

    Madrid

  • Hospital Universitario La Paz, Servicio Dermatología

    Madrid

  • Clínica Universitaria de Navarra, Servicio Dermatología

    Pamplona, Navarre

  • Hospital Virgen de la Macarena, Servicio Dermatología

    Seville, Andalusia

  • Hospital Universitario y Politécnico La Fe, Servicio Dermatología

    Valencia

Other trials in Spain

About this study

Official title: 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

Primary objective:

To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (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.

Maintenance objective:

To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.

Read the detailed description

Subjects found eligible following the screening period were randomized 3:1 to initial treatment with tralokinumab 300 mg every 2 weeks (Q2W) or placebo. Randomization was stratified by region (North America, Europe, and Japan) and disease severity (Investigator's Global Assessment [IGA] 3 or 4).

Subjects achieving a clinical response at Week 16 (defined as IGA of 0 or 1 on a 5-point scale ranging from 0 [clear] to 4 [severe], or at least 75% reduction in Eczema Area and Severity Index [EASI] score from baseline [EASI75]) continued into maintenance treatment that continued until Week 52.

Subjects randomized to tralokinumab in the initial treatment period and who achieved a clinical response at Week 16 (defined by IGA 0 or 1, or EASI75) were re-randomized 2:2:1 to one of the following Q2W maintenance regimens stratified by region (North America, Europe, and Japan) and IGA response at Week 16 (IGA 0/1 or IGA >1):

  • Tralokinumab 300 mg Q2W.
  • Tralokinumab 300 mg Q4W (alternating dose administrations tralokinumab 300 mg and placebo).
  • Placebo (Subjects randomized to placebo in the initial treatment period who achieved a clinical response at Week 16 [defined by IGA 0 or 1, or EASI75] continued to receive placebo Q2W in the maintenance treatment period).

Subjects not achieving a clinical response at Week 16 as well as those who met the criteria listed below during maintenance treatment were transferred to open-label tralokinumab 300 mg Q2W treatment with optional use of topical corticosteroid (TCS) up to Week 52.

Transfer to open-label treatment during maintenance:

Subjects with IGA=0 at Week 16: IGA of at least 2 and not achieved EASI75 over at least a 4-week period (i.e. over 3 consecutive visits).

Subjects with IGA=1 at Week 16: IGA of at least 3 and not achieved EASI75 over at least a 4-week period (i.e. over 3 consecutive visits).

Subjects with IGA >1 at Week 16: not achieved EASI75 over at least a 4-week period (i.e. over 3 consecutive visits).

Subjects transferring to open-label treatment had the option to self-administer tralokinumab in their home after adequate training (at 3 dosing visits in the open-label period after additional consent has been obtained) by site staff at the investigator's discretion.

After completion of the maintenance treatment period (or open-label treatment), all subjects, except for those who entered the open-label long-term extension trial, continued in a 14-week off-treatment follow-up period for the assessment of safety and anti-drug antibody (ADA).

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 NCT03131648
Study groupRoleWhat they receive
Initial treatment period - Tralokinumab Q2WExperimentalWeek 0 to Week 16: Two subcutaneous (SC) injections of tralokinumab as a loading dose on Day 0, followed by a SC injection of tralokinumab Q2W regimen for 16 weeks.
Receives: Drug: Tralokinumab
Initial treatment period - Placebo Q2WPlacebo comparatorWeek 0 to Week 16: Two subcutaneous (SC) injections of placebo as a loading dose on Day 0 followed by a SC injection of placebo Q2W regimen for 16 weeks.
Receives: Drug: Placebo
Maintenance treatment period - Tralokinumab Q2WExperimentalWeek 16 to Week 52: Tralokinumab responders from the initial treatment period re-randomised at Week 16 and administered tralokinumab maintenance subcutaneous injection regimen Q2W for 36 weeks.
Receives: Drug: Tralokinumab
Maintenance treatment period - Tralokinumab Q4WExperimentalWeek 16 to Week 52: Tralokinumab responders from the initial treatment period re-randomised at Week 16 and administered tralokinumab maintenance subcutaneous injection regimen Q4W for 36 weeks. Subjects in this group receive alternating doses of tralokinumab SC injection and placebo SC injection every 2 weeks.
Receives: Drug: Tralokinumab; Drug: Placebo
Maintenance treatment period - Placebo Q2WPlacebo comparatorWeek 16 to Week 52: Tralokinumab responders from initial treatment period randomised at Week 16 and administered placebo subcutaneous maintenance injection for 36 weeks.
Receives: Drug: Placebo
Maintenance treatment period - PlaceboPlacebo comparatorWeek 16 to Week 52: Placebo responders from the initial treatment period re-assigned at Week 16 and administered placebo maintenance subcutaneous injection regimen Q2W for 36 weeks.
Receives: Drug: Placebo
Open-label treatment - Tralokinumab + optional TCSExperimentalWeek 16 to Week 52: Subjects receiving initial treatment with tralokinumab Q2W or placebo Q2W assigned to open-label treatment at Week 16 and administered Tralokinumab subcutaneous (SC) injection + optional TCS* regimen Q2W. OR Subjects receiving maintenance treatment with tralokinumab Q2W/Q4W or placebo assigned to open-label treatment after Week 16 and administered tralokinumab SC injection + optional TCS* regimen Q2W. *TCS = topical corticosteroids.
Receives: Drug: Tralokinumab
Open-label short-term- Tralokinumab + optional TCSExperimentalWeek 52 to Week 68 [Short term extension (Japan only)] : Japanese subjects who were transferred to the open-label tralokinumab Q2W arm at Week 16 continued an additional 16 weeks (Week 52 to Week 66) of open-label treatment to receive 52 weeks of active therapy.
Receives: Drug: Tralokinumab

What is being measured

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

  1. 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

  2. Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI] 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 (15)

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

    Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

    Measured: Week 0 to Week 16

  2. Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to 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 higher values 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

    The Dermatology Life Quality Index (DLQI) 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 different aspects of their quality of life (QoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all ⁄not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.

    Measured: Week 0 to Week 16

  4. Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA of 0/1 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 52

  5. Subjects With at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 52 Among Subjects With 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 52

  6. Safety and Tolerability: Adverse Event (AE) /Serious Adverse Event (SAE) Frequency

    Overall summary of AEs and SAEs during the Initial treatment period is presented. For list of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the entire trial period (including safety follow-up), see Adverse Events Overview section.

    Measured: Week 0 to Week 16

  7. Frequency of Anti-drug Antibodies

    Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.

    Measured: Week 0 to Week 16

  8. Subjects Achieving at Least 50% Reduction in Eczema Area and Severity Index [EASI] 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

  9. Subjects Achieving at Least 90% Reduction in Eczema Area and Severity Index [EASI] 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

  10. Change From Baseline to Week 16 in Eczema Area and Severity Index [EASI] Score

    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: Week 0 to Week 16

  11. Subjects Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) 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

  12. Subjects Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) 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 higher values indicating a more extensive and/or severe condition.

    Measured: At Week 16

  13. Change From Baseline to Week 16 in Worst Daily Pruritus NRS (Weekly Average)

    Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'

    Measured: Week 0 to Week 16

  14. Reduction of Worst Daily Pruritus NRS (Weekly Average) ≥3 From Baseline to Week 16

    Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

    Measured: Week 0 to Week 16

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

    The DLQI 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 different aspects of their QoL over the last week such as dermatology related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.

    Measured: Week 0 to Week 16

Timeline

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

  1. First posted27 Apr 2017
  2. Study start30 May 2017
  3. Primary completion7 Aug 2018
  4. Study completion10 Oct 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
802 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03131648
Sponsor's protocol ID
LP0162-1325
Other IDs
2016-004200-65, 2016
Acronym
ECZTRA 1
Status last verified
Feb 2023
First submitted
24 Apr 2017
Last updated
11 Mar 2025
Data monitoring committee
Yes
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

  • 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

  • Chovatiya R, Ribero S, Wollenberg A, Park CO, Silvestre JF, Hong HC, Seneschal J, Saeki H, Thyssen JP, Oland CB, Gjerum L, Maslin D, Blauvelt A. Long-Term Disease Control and Minimal Disease Activity of Head and Neck Atopic Dermatitis in Patients Treated with Tralokinumab up to 4 Years. Am J Clin Dermatol. 2025 Jul;26(4):587-601. doi: 10.1007/s40257-025-00931-1. Epub 2025 Mar 14.

    PubMed 40085349

  • Guttman-Yassky E, Kabashima K, Staumont-Salle D, Nahm WK, Pauser S, Da Rosa JC, Martel BC, Madsen DE, Ropke M, Arlert P, Steffensen L, Blauvelt A, Reich K. Targeting IL-13 with tralokinumab normalizes type 2 inflammation in atopic dermatitis both early and at 2 years. Allergy. 2024 Jun;79(6):1560-1572. doi: 10.1111/all.16108. Epub 2024 Apr 2.

    PubMed 38563683

  • Simpson EL, Blauvelt A, Silverberg JI, Cork MJ, Katoh N, Mark T, Schneider SKR, Wollenberg A. Tralokinumab Provides Clinically Meaningful Responses at Week 16 in Adults with Moderate-to-Severe Atopic Dermatitis Who Do Not Achieve IGA 0/1. Am J Clin Dermatol. 2024 Jan;25(1):139-148. doi: 10.1007/s40257-023-00817-0. Epub 2023 Oct 7.

    PubMed 37804473

  • Simpson EL, Pink AE, Blauvelt A, Gooderham M, Armstrong AW, Worm M, Katoh N, Peris K, Puig L, Barbarot S, Mark T, Steffensen LA, Tindberg AM, Wollenberg A. Tralokinumab Efficacy Over 1 Year in Adults with Moderate-to-Severe Atopic Dermatitis: Pooled Data from Two Phase III Trials. Am J Clin Dermatol. 2023 Nov;24(6):939-952. doi: 10.1007/s40257-023-00806-3. Epub 2023 Sep 8.

    PubMed 37682422

  • Beck LA, Bieber T, Weidinger S, Tauber M, Saeki H, Irvine AD, Eichenfield LF, Werfel T, Arlert P, Jiang L, Ropke M, Paller AS. Tralokinumab treatment improves the skin microbiota by increasing the microbial diversity in adults with moderate-to-severe atopic dermatitis: Analysis of microbial diversity in ECZTRA 1, a randomized controlled trial. J Am Acad Dermatol. 2023 Apr;88(4):816-823. doi: 10.1016/j.jaad.2022.11.047. Epub 2022 Dec 5.

    PubMed 36473633

  • 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

  • Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour JP, Spelman L, Katoh N, Saeki H, Poulin Y, Lesiak A, Kircik L, Cho SH, Herranz P, Cork MJ, Peris K, Steffensen LA, Bang B, Kuznetsova A, Jensen TN, Osterdal ML, Simpson EL; ECZTRA 1 and ECZTRA 2 study investigators. 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). Br J Dermatol. 2021 Mar;184(3):437-449. doi: 10.1111/bjd.19574. Epub 2020 Dec 30.

    PubMed 33000465

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 123 sites in 5 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 16 inclusion and 48 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 123 sites in United States, Japan, Germany, France, Spain. 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 20 Nov 2020). 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 NCT03131648, which also lists 9 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.

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