Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)
ECZTRA 1
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
2 other identifiers
interventional
802
5 countries
123
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2017
123 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2017
CompletedFirst Posted
Study publicly available on registry
April 27, 2017
CompletedStudy Start
First participant enrolled
May 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2019
CompletedResults Posted
Study results publicly available
November 20, 2020
CompletedMarch 11, 2025
February 1, 2023
1.2 years
April 24, 2017
September 15, 2020
February 21, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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).
At Week 16
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.
At Week 16
Secondary Outcomes (15)
Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16.
Week 0 to Week 16
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16
Week 0 to Week 16
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16
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
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
At Week 52
- +10 more secondary outcomes
Study Arms (8)
Initial treatment period - Tralokinumab Q2W
EXPERIMENTALWeek 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.
Initial treatment period - Placebo Q2W
PLACEBO 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.
Maintenance treatment period - Tralokinumab Q2W
EXPERIMENTALWeek 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.
Maintenance treatment period - Tralokinumab Q4W
EXPERIMENTALWeek 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.
Maintenance treatment period - Placebo Q2W
PLACEBO COMPARATORWeek 16 to Week 52: Tralokinumab responders from initial treatment period randomised at Week 16 and administered placebo subcutaneous maintenance injection for 36 weeks.
Maintenance treatment period - Placebo
PLACEBO 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.
Open-label treatment - Tralokinumab + optional TCS
EXPERIMENTALWeek 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.
Open-label short-term- Tralokinumab + optional TCS
EXPERIMENTALWeek 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.
Interventions
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 contains the same excipients, in the same concentration only lacking tralokinumab
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- 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).
You may not qualify if:
- 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:
- 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.
- +33 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (123)
Clinical Research Center of Alabama
Birmingham, Alabama, 35209, United States
Tien Q. Nguyen, MD, Inc.
Fountain Valley, California, 92708, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Quest Dermatology Research
Northridge, California, 91324, United States
Dermatology Specialists, Inc.
Oceanside, California, 92056, United States
Center for Dermatology and Laser Surgery
Sacramento, California, 95819, United States
University Clinical Trials, Inc.
San Diego, California, 92123, United States
The GWU Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Skin Care Research, Inc.
Boca Raton, Florida, 33486, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
Forward Clinical Trials
Tampa, Florida, 33624, United States
Research Institute of the Southeast, LLC
West Palm Beach, Florida, 33401, United States
ACRC Dermatology
West Palm Beach, Florida, 33406, United States
Georgia Pollens Clinical Research Centers, Inc.
Albany, Georgia, 31707, United States
Allergy Center at Brookstone Research
Columbus, Georgia, 31904, United States
Dermatologic Surgery Specialists
Macon, Georgia, 31217, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
PMG Research of Christie Clinic
Chicago, Illinois, 61820, United States
Deaconess Clinic
Evansville, Indiana, 47713, United States
Skin Sciences, PLLC
Louisville, Kentucky, 40217, United States
Clinical Trials of SWLA, LLC
Lake Charles, Louisiana, 70601, United States
DermAssociates, PC
Rockville, Maryland, 20850, United States
Clarkston Skin Research
Clarkston, Michigan, 48346, United States
Derm Center
Troy, Michigan, 48084, United States
MediSearch LLC
Saint Joseph, Missouri, 64506, United States
JDR Dermatology Research
Las Vegas, Nevada, 89148, United States
University at Buffalo Department of Dermatology
Buffalo, New York, 14203, United States
Weil Cornell Medicine
New York, New York, 10021, United States
Juva Skin & Laser Center
New York, New York, 10022, United States
Deramatology Consulting Services, PLLC
High Point, North Carolina, 27262, United States
Dermatologists of Greater Columbus
Bexley, Ohio, 43209, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Oregon Health & Sciences University
Portland, Oregon, 97239, United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213, United States
Austin Dermatology Associates
Austin, Texas, 78705, United States
Tekton Research
Austin, Texas, 78745, United States
Dermtology Treatment and Research Center
Dallas, Texas, 75230, United States
Houston Skin Associates
Houston, Texas, 77004, United States
Center for Clinical Studies
Webster, Texas, 77958, United States
Virginia Clinical Research
Norfolk, Virginia, 23502, United States
Dermatology Associates of Seattle
Seattle, Washington, 98101, United States
West Virginia Research Institute
Morgantown, West Virginia, 26505, United States
Centre Hospitalier de Valence
Valence, Drôme, France
Hôpital St ANDRE, CHU de BORDEAUX, Service de Dermatologie
Bordeaux, France
CHRU de Brest - Hôpital Morvan, Service de Dermatologie
Brest, France
CHU de Dijon, Service de Dermatologie
Dijon, France
Hôpital Claude Huriez-CHRU, Service de dermatologie
Lille, France
Hôpital Saint vincent de paul, Clinique de Dermatologie
Lille, France
Cabinet Médical, Le Bateau Blanc-Immeuble A
Martigues, France
GHRMSA, Service de Dermatologie
Mulhouse, 68100, France
Centre Hospitalier Universitaire, Clinique dermatologique 7 eme nord
Nantes, France
Hôpital de l'Archet II, Service de Dermatologie- Vénérologie
Nice, France
Hôpital Robert Debré, Service de Dermatologie
Reims, France
Hôpital Charles Nicolle, Clinique Dermatologique
Rouen, France
C.H.U. de Saint-Etienne - Hôpital Nord, Service de dermatologie
Saint-Etienne, France
CHU de Toulouse Hôpital Larrey, Service de Dermatologie
Toulouse, France
Derma-Study-Center Friedrichshafen GmbH
Friedrichshafen, Baden-Wurttemberg, Germany
Klinikum Augsburg, Klinik für Dermatologie und Allergologie
Augsburg, Bavaria, Germany
Universitätsklinikum Erlangen, Hautklinik
Erlangen, Bavaria, Germany
LMU München, Klinik und Poliklinik für Dermatologie und Allergologie
München, Bavaria, Germany
Facharztpraxis für Dermatologie, Allergologie, Venerologie und Umweltmedizin
Mahlow, Brandenburg, Germany
Klinikum Darmstadt GmbH, Hautklinik
Darmstadt, Hessia, Germany
Hautärzte Zentrum Hannover
Hannover, Lower Saxony, 30159, Germany
Medizinische Hochschule Hannover, Klinik für Dermatologie, Allergologie und Venerologie
Hannover, Lower Saxony, Germany
KliFOs - Klinische Forschung Osnabrück
Osnabrück, Lower Saxony, Germany
Klinikum Bielefeld Rosenhöhe, Hautklinik
Bielefeld, North Rhine-Westphalia, Germany
Niesmann, Hautzentrum im Jahrhunderthaus
Bochum, North Rhine-Westphalia, Germany
Universitätsklinikum Bonn, Klinik und Poliklinik für Dermatologie und Allergologie
Bonn, North Rhine-Westphalia, Germany
Hautzentrum Dülmen
Dülmen, North Rhine-Westphalia, Germany
Universitätsklinikum Essen (AöR), Klinik für Dermatologie, Venerologie und Allergologie
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Münster Klinik und Poliklinik für Hautkrankheiten Münster, Zentrale Studienkoordination für innovative Dermatologie
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Dermatologie
Dresden, Saxony, Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Leipzig, Saxony, Germany
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Dermatologie und Venerologie
Halle, Saxony-Anhalt, Germany
SRH Wald-Klinikum Gera, Klinik für klinische Studien
Gera, Thuringia, Germany
Charité - Universitätsmedizin Berlin, Klinik für Dermatologie, Allergologie und Venerologie
Berlin, Germany
CMB Collegium Medicum Berlin GmbH
Berlin, Germany
SCIderm GmbH
Hamburg, Germany
Meiwa Hospital
Hyōgo, Nishinomiya, 663-8186, Japan
Hyogo College Of Medicine Hospital
Hyōgo, Nishinomiya, 663-8501, Japan
KUME Clinic
Sakai, Osaka, 593-8324, Japan
NTT Medical Center Tokyo
Tokyo, Shinagawa, 141-8625, Japan
Asahikawa City Hospital
Asahikawa, 070-8610, Japan
JR Sapporo Hospital
Chūō, 060-0033, Japan
Medical Corporation Kojinkai
Chūō, 060-0063, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Kurume University Hospital
Fukuoka, 830-0011, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
Gifu University Hospital
Gifu, 315-0974, Japan
Osaka Habikono Medical Center
Habikino, 583-8588, Japan
Hamamatsu University hospital
Hamamatsu, 431-3192, Japan
Ichinomiya Municipal Hospital
Ichinomiya, 491-8558, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Kyoto Prefectural Hospital
Kyoto, 602-8566, Japan
Iwate Prefectural Central Hospital
Morioka, 020-0066, Japan
Chukyo Hospital
Nagoya, 457-8510, Japan
Takagi Dermatological Clinic
Obihiro, Japan
Gokeikai Osaka Kaisei Hospital
Ōsaka, 532-0003, Japan
Osaka Hospital
Ōsaka, 553-0003, Japan
Jichi Medical University Hospital
Tochigi, 329-0498, Japan
Tokyo Teishin Hospital
Tokyo, 102-8798, Japan
The Jikei University Hospital
Tokyo, 105-8471, Japan
Nippon Medical School Hospital
Tokyo, 113-8603, Japan
The Fraternity Memorial Hospital
Tokyo, 130-8587, Japan
Tokyo Medical University Hospital
Tokyo, 160-0023, Japan
Ogikubo Hospital
Tokyo, 167-0035, Japan
Shirasaki Dermatology Clinic
Tōyama, 933-0871, Japan
Hospital Reina Sofía, Servicio Dermatología
Córdoba, Andalusia, Spain
Hospital Virgen de la Macarena, Servicio Dermatología
Seville, Andalusia, Spain
Hospital de Basurto, Servicio Dermatología
Bilbao, Basque Country, Spain
Hospital de Cruces, Servicio Dermatología
Bilbao, Basque Country, Spain
Hospital Germans Trias i Pujol, Servicio Dermatología
Badalona, Catalonia, Spain
Hospital Clinic de Barcelona, Dermatology Department
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau, Servicio Dermatología
Barcelona, Catalonia, Spain
Hospital del Mar, Servicio Dermatología
Barcelona, Catalonia, Spain
Clínica Universitaria de Navarra, Servicio Dermatología
Pamplona, Navarre, 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
Madrid, Spain
Hospital Universitario y Politécnico La Fe, Servicio Dermatología
Valencia, Spain
Related Publications (9)
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. 2025 Oct 21. doi: 10.1007/s40257-025-00985-1. Online ahead of print.
PMID: 41118053DERIVEDPaller 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.
PMID: 40555305DERIVEDChovatiya 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.
PMID: 40085349DERIVEDGuttman-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.
PMID: 38563683DERIVEDSimpson 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.
PMID: 37804473DERIVEDSimpson 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.
PMID: 37682422DERIVEDBeck 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.
PMID: 36473633DERIVEDBlauvelt 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.
PMID: 36152216DERIVEDWollenberg 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.
PMID: 33000465DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Disclosure
- Organization
- LEO Pharma A/S
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Wollenberg, Prof. Dr. med.
Department of Dermatology and Allergy, Ludwig-Maximilian University Munich, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Neither the subject nor any of the investigator or LEO staff who are involved in the treatment or clinical evaluation and monitoring of the subjects will be aware of the treatment received. The packaging and labelling of the IMPs will contain no evidence of their identity. Since tralokinumab and placebo are visually distinct and not matched for viscosity, IMP will be handled and administered by a qualified, unblinded HCP at the site who will not be involved in the management of trial subjects and who will not perform any of the assessments.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2017
First Posted
April 27, 2017
Study Start
May 30, 2017
Primary Completion
August 7, 2018
Study Completion
October 10, 2019
Last Updated
March 11, 2025
Results First Posted
November 20, 2020
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share