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

February 21, 2025 updated by: LEO Pharma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
802

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Hôpital St ANDRE, CHU de BORDEAUX, Service de Dermatologie
      • Brest Cedex, France
        • CHRU de Brest - Hôpital Morvan, Service de Dermatologie
      • Dijon, France
        • CHU de Dijon, Service de dermatologie
      • Lille, France
        • Hôpital Claude Huriez-CHRU, Service de dermatologie
      • Lille Cedex, France
        • Hôpital Saint vincent de paul, Clinique de Dermatologie
      • Martigues, France
        • Cabinet Médical, Le Bateau Blanc-Immeuble A
      • Mulhouse, France, 68100
        • GHRMSA, Service de Dermatologie
      • Nantes, France
        • Centre Hospitalier Universitaire, Clinique dermatologique 7 eme nord
      • Nice, France
        • Hôpital de l'Archet II, Service de Dermatologie- Vénérologie
      • Reims, France
        • Hôpital Robert Debré, Service de Dermatologie
      • Rouen, France
        • Hôpital Charles Nicolle, Clinique Dermatologique
      • Saint-Etienne Cedex 2, France
        • C.H.U. de Saint-Etienne - Hôpital Nord, Service de dermatologie
      • Toulouse, France
        • CHU de Toulouse Hôpital Larrey, Service de Dermatologie
    • Drôme
      • Valence, Drôme, France
        • centre hospitalier de Valence
  • Germany
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin, Klinik für Dermatologie, Allergologie und Venerologie
      • Berlin, Germany
        • CMB COLLEGIUM MEDICUM BERLIN GmbH
      • Hamburg, Germany
        • SCIderm GmbH
    • Baden-Württemberg
      • Friedrichshafen, Baden-Württemberg, Germany
        • Derma-Study-Center Friedrichshafen GmbH
    • Bavaria
      • Augsburg, Bavaria, Germany
        • Klinikum Augsburg, Klinik für Dermatologie und Allergologie
      • Erlangen, Bavaria, Germany
        • Universitätsklinikum Erlangen, Hautklinik
      • München, Bavaria, Germany
        • LMU München, Klinik und Poliklinik für Dermatologie und Allergologie
    • Brandenburg
      • Mahlow, Brandenburg, Germany
        • Facharztpraxis für Dermatologie, Allergologie, Venerologie und Umweltmedizin
    • Hessia
      • Darmstadt, Hessia, Germany
        • Klinikum Darmstadt GmbH, Hautklinik
    • Lower Saxony
      • Hannöver, Lower Saxony, Germany, 30159
        • Hautärzte Zentrum Hannover
      • Hannöver, Lower Saxony, Germany
        • Medizinische Hochschule Hannover, Klinik für Dermatologie, Allergologie und Venerologie
      • Osnabrück, Lower Saxony, Germany
        • Klifos - Klinische Forschung Osnabruck
    • NRW
      • Bielefeld, NRW, Germany
        • Klinikum Bielefeld Rosenhöhe, Hautklinik
      • Bochum, NRW, Germany
        • Niesmann, Hautzentrum im Jahrhunderthaus
      • Bonn, NRW, Germany
        • Universitätsklinikum Bonn, Klinik und Poliklinik für Dermatologie und Allergologie
      • Dülmen, NRW, Germany
        • Hautzentrum Dulmen
      • Essen, NRW, Germany
        • Universitätsklinikum Essen (AöR), Klinik für Dermatologie, Venerologie und Allergologie
      • Münster, NRW, Germany
        • Universitätsklinikum Münster Klinik und Poliklinik für Hautkrankheiten Münster, Zentrale Studienkoordination für innovative Dermatologie
    • Saxony
      • Dresden, Saxony, Germany
        • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Dermatologie
      • Leipzig, Saxony, Germany
        • Universitätsklinikum Leipzig, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
    • Saxony-Anhalt
      • Halle (Saale), Saxony-Anhalt, Germany
        • Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Dermatologie und Venerologie
    • Thuringia
      • Gera, Thuringia, Germany
        • SRH Wald-Klinikum Gera, Klinik für klinische Studien
  • Japan
      • Asahikawa, Japan, 070-8610
        • Asahikawa City Hospital
      • Chūō, Japan, 060-0033
        • JR Sapporo Hospital
      • Chūō, Japan, 060-0063
        • Medical Corporation Kojinkai
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Fukuoka, Japan, 830-0011
        • Kurume University Hospital
      • Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital
      • Gifu-shi, Japan, 315-0974
        • Gifu University Hospital
      • Habikino, Japan, 583-8588
        • Osaka Habikono Medical Center
      • Hamamatsu, Japan, 431-3192
        • Hamamatsu University Hospital
      • Ichinomiya, Japan, 491-8558
        • Ichinomiya Municipal Hospital
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Kyoto, Japan, 602-8566
        • Kyoto Prefectural Hospital
      • Morioka, Japan, 020-0066
        • Iwate Prefectural Central Hospital
      • Nagoya, Japan, 457-8510
        • Chukyo Hospital
      • Obihiro, Japan
        • Takagi Dermatological Clinic
      • Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tokyo, Japan, 167-0035
        • Ogikubo Hospital
      • Tokyo, Japan, 105-8471
        • The Jikei University Hospital
      • Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital
      • Tokyo, Japan, 102-8798
        • Tokyo Teishin Hospital
      • Tokyo, Japan, 130-8587
        • The Fraternity Memorial Hospital
      • Tōyama, Japan, 933-0871
        • Shirasaki Dermatology Clinic
      • Ōsaka, Japan, 532-0003
        • Gokeikai Osaka Kaisei Hospital
      • Ōsaka, Japan, 553-0003
        • Osaka Hospital
    • Nishinomiya
      • Hyōgo, Nishinomiya, Japan, 663-8186
        • Meiwa Hospital
      • Hyōgo, Nishinomiya, Japan, 663-8501
        • Hyogo College of Medicine Hospital
    • Osaka
      • Sakai City, Osaka, Japan, 593-8324
        • Kume Clinic
    • Shinagawa
      • Tokyo, Shinagawa, Japan, 141-8625
        • Ntt Medical Center Tokyo
  • Spain
      • Madrid, Spain
        • Hospital de Fuenlabrada, Servicio Dermatología
      • Madrid, Spain
        • Hospital Infanta Leonor, Servicio Dermatología
      • Madrid, Spain
        • Hospital Universitario de la Princesa, Servicio Dermatología
      • Madrid, Spain
        • Hospital Universitario La Paz, Servicio Dermatología
      • Valencia, Spain
        • Hospital Universitario y Politécnico La Fe, Servicio Dermatología
    • Andalucía
      • Córdoba, Andalucía, Spain
        • Hospital Reina Sofía, Servicio Dermatología
      • Sevilla, Andalucía, Spain
        • Hospital Virgen de la Macarena, Servicio Dermatología
    • Catalunya
      • Badalona, Catalunya, Spain
        • Hospital Germans Trias i Pujol, Servicio Dermatología
      • Barcelona, Catalunya, Spain
        • Hospital Clinic de Barcelona, Dermatology Department
      • Barcelona, Catalunya, Spain
        • Hospital de la Santa Creu i Sant Pau, Servicio Dermatología
      • Barcelona, Catalunya, Spain
        • Hospital del Mar, Servicio Dermatología
    • Navarra
      • Pamplona, Navarra, Spain
        • Clínica Universitaria de Navarra, Servicio Dermatología
    • País Vasco
      • Bilbao, País Vasco, Spain
        • Hospital de Basurto, Servicio Dermatología
      • Bilbao, País Vasco, Spain
        • Hospital de Cruces, Servicio Dermatología
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Clinical Research Center of Alabama
    • California
      • Fountain Valley, California, United States, 92708
        • Tien Q. Nguyen, MD, Inc.
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Northridge, California, United States, 91324
        • Quest Dermatology Research
      • Oceanside, California, United States, 92056
        • Dermatology Specialists, Inc.
      • Sacramento, California, United States, 95819
        • Center for Dermatology and Laser Surgery
      • San Diego, California, United States, 92123
        • University Clinical Trials, Inc.
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • The GWU Medical Faculty Associates
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Skin Care Research, Inc.
      • Orange Park, Florida, United States, 32073
        • Park Avenue Dermatology
      • Tampa, Florida, United States, 33624
        • Forward Clinical Trials
      • West Palm Beach, Florida, United States, 33401
        • Research Institute of the Southeast, Llc
      • West Palm Beach, Florida, United States, 33406
        • ACRC Dermatology
    • Georgia
      • Albany, Georgia, United States, 31707
        • Georgia Pollens Clinical Research Centers, Inc.
      • Columbus, Georgia, United States, 31904
        • Allergy Center at Brookstone Research
      • Macon, Georgia, United States, 31217
        • Dermatologic Surgery Specialists
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Altman Dermatology Associates
      • Chicago, Illinois, United States, 61820
        • PMG Research of Christie Clinic
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Deaconess Clinic
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Skin Sciences, PLLC
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Clinical Trials of SWLA, LLC
    • Maryland
      • Rockville, Maryland, United States, 20850
        • DermAssociates, PC
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Clarkston Skin Research
      • Troy, Michigan, United States, 48084
        • Derm Center
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • MediSearch LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • JDR Dermatology Research
    • New York
      • Buffalo, New York, United States, 14203
        • University at Buffalo Department of Dermatology
      • New York, New York, United States, 10022
        • JUVA Skin & Laser Center
      • New York, New York, United States, 10021
        • Weil Cornell Medicine
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Deramatology Consulting Services, PLLC
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Dermatologists of Greater Columbus
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Sciences University
      • Portland, Oregon, United States, 97223
        • Oregon Medical Research Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Department of Dermatology
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Dermatology Associates
      • Austin, Texas, United States, 78745
        • Tekton Research
      • Dallas, Texas, United States, 75230
        • Dermtology Treatment and Research Center
      • Houston, Texas, United States, 77004
        • Houston Skin Associates
      • Webster, Texas, United States, 77958
        • Center for Clinical Studies
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Clinical Research
    • Washington
      • Seattle, Washington, United States, 98101
        • Dermatology Associates of Seattle
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • West Virginia Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Written informed consent and any locally required authorisation obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
  2. Age 18 and above.
  3. Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD (34; Appendix 5).
  4. Diagnosis of AD for ≥1 year.

  5. 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.

    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.

  6. AD involvement of ≥10% body surface area at screening and baseline (visit 3).
  7. An EASI score of ≥12 at screening and 16 at baseline.
  8. An IGA score of ≥3 at screening and at baseline.

  9. 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.

  10. 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).

  11. 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).

Exclusion Criteria:

  1. Concurrent enrolment in another clinical trial where the subject is receiving an IMP.
  2. Previous randomisation in tralokinumab trials.
  3. Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, or psoriasis.
  4. Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
  5. 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.

  6. Treatment with the following medications within 4 weeks prior to randomisation:

    • 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.

  7. Treatment with the following medications within 2 weeks prior to randomisation

    • TCS.
    • TCI.
    • Topical PDE 4 inhibitor.
  8. 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).

  9. 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.

  10. 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.
  11. Receipt of any investigational non-biologic agent within 5 half-lives prior to randomisation.
  12. Receipt of blood products within 4 weeks prior to screening.
  13. Major surgery within 8 weeks prior to screening, or planned in-patient surgery or hospitalisation during the trial period.
  14. Known or suspected allergy or reaction to any component of the IMP formulation.
  15. History of any active skin infection within 1 week prior to randomisation.

  16. 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.
  17. 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.
  18. History of anaphylaxis following any biologic therapy.
  19. History of immune complex disease.

  20. 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.
  21. Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care.
  22. 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.
  23. 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.
  24. 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).

  25. 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.
  26. 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.
  27. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0 times the ULN (upper limit of normal) at screening.
  28. 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.
  29. 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.
  30. Subjects who are legally institutionalised.
  31. Pregnant, breastfeeding, or lactating women.
  32. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Initial treatment period - Tralokinumab Q2W

Week 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.
Drug: Tralokinumab
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
Placebo Comparator: Initial treatment period - Placebo Q2W

Week 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.
Drug: Placebo
Placebo contains the same excipients, in the same concentration only lacking tralokinumab
Experimental: Maintenance treatment period - Tralokinumab Q2W

Week 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.
Drug: Tralokinumab
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
Experimental: Maintenance treatment period - Tralokinumab Q4W

Week 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.
Drug: Tralokinumab
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
Drug: Placebo
Placebo contains the same excipients, in the same concentration only lacking tralokinumab
Placebo Comparator: Maintenance treatment period - Placebo Q2W

Week 16 to Week 52:

Tralokinumab responders from initial treatment period randomised at Week 16 and administered placebo subcutaneous maintenance injection for 36 weeks.
Drug: Placebo
Placebo contains the same excipients, in the same concentration only lacking tralokinumab
Placebo Comparator: Maintenance treatment period - Placebo

Week 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.
Drug: Placebo
Placebo contains the same excipients, in the same concentration only lacking tralokinumab
Experimental: Open-label treatment - Tralokinumab + optional TCS

Week 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.
Drug: Tralokinumab
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
Experimental: Open-label short-term- Tralokinumab + optional TCS

Week 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.
Drug: Tralokinumab
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
At Week 16
Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI] 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.
At Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16.
Time Frame: Week 0 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'.
Week 0 to Week 16
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16
Time Frame: Week 0 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.
Week 0 to Week 16
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16
Time Frame: Week 0 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.
Week 0 to Week 16
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
Time Frame: At Week 52
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At Week 52
Subjects With at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 52 Among Subjects With EASI75 at Week 16
Time Frame: At Week 52
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At Week 52
Safety and Tolerability: Adverse Event (AE) /Serious Adverse Event (SAE) Frequency
Time Frame: Week 0 to Week 16
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.
Week 0 to Week 16
Frequency of Anti-drug Antibodies
Time Frame: Week 0 to Week 16
Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.
Week 0 to Week 16
Subjects Achieving at Least 50% Reduction in Eczema Area and Severity Index [EASI] 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.
At Week 16
Subjects Achieving at Least 90% Reduction in Eczema Area and Severity Index [EASI] 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.
At Week 16
Change From Baseline to Week 16 in Eczema Area and Severity Index [EASI] Score
Time Frame: Week 0 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.
Week 0 to Week 16
Subjects Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16
Time Frame: 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.
At Week 16
Subjects Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16
Time Frame: 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.
At Week 16
Change From Baseline to Week 16 in Worst Daily Pruritus NRS (Weekly Average)
Time Frame: Week 0 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'
Week 0 to Week 16
Reduction of Worst Daily Pruritus NRS (Weekly Average) ≥3 From Baseline to Week 16
Time Frame: Week 0 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'.
Week 0 to Week 16
Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of ≥4 Points Among Subjects With Baseline DLQI ≥4
Time Frame: Week 0 to Week 16
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.
Week 0 to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LEO Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas Wollenberg, Prof. Dr. med., Department of Dermatology and Allergy, Ludwig-Maximilian University Munich, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 7, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LP0162-1325
  • 2016-004200-65 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Sharing Access Criteria

De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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