Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2)
ECZTRA 2
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
794
9 countries
115
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 Jun 2017
115 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
May 18, 2017
CompletedFirst Posted
Study publicly available on registry
May 19, 2017
CompletedStudy Start
First participant enrolled
June 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2019
CompletedResults Posted
Study results publicly available
August 24, 2020
CompletedMarch 11, 2025
February 1, 2023
1.2 years
May 18, 2017
August 7, 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].
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 (7)
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
PLACEBO COMPARATORWeek 0 to Week 16 (Initial treatment period): 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. Participants in this group receive alternating doses of tralokinumab SC injection and placebo SC injection every 2 weeks
Maintenance treatment period - Placebo
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 (tralokinumab naive)
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 300 mg Q2W + 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
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 (33; 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 (115)
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
California dermatology
Encinitas, California, 92024, United States
Advanced SkinCare Surgery & Med Center
Fullerton, California, 92835, United States
USC Department of Dermatology
Los Angeles, California, 90033, United States
Thiele Dermatology Specialists, Inc
Murrieta, California, 92562, United States
Island Dermatology
Newport Beach, California, 92660, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
San Luis Dermatology and Laser Clinic
San Luis Obispo, California, 93405, United States
Southern California Dermatology, Inc.
Santa Ana, California, 92701, United States
Olympian Clinical Research
Clearwater, Florida, 33756, United States
Spotlight Research Center, LLC
Miami, Florida, 33176, United States
Private Practice - Dr. Tory P. Sullivan
North Miami Beach, Florida, 33162, United States
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, 30060, United States
MedaPhase, Inc.
Newnan, Georgia, 30263, United States
Northwestern University
Chicago, Illinois, 60611, United States
RUSH University
Chicago, Illinois, 60612, United States
Dawes-Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256, United States
Kansas City Dermatology, PA
Overland Park, Kansas, 66215, United States
Beacon Clinical Research
Quincy, Massachusetts, 02169, United States
HFMC New Center One
Detroit, Michigan, 48202, United States
The Grekin Skin Institute
Warren, Michigan, 48088, United States
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197, United States
Clinical Studies Group
Henderson, Nevada, 89074, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Corning Center for Clinical Research
Corning, New York, 14830, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Sadick Dermatology
New York, New York, 10075, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Health Physicians Office
Cincinnati, Ohio, 45267, United States
Wright State Physicians
Fairborn, Ohio, 45324, United States
Aventiv Research Inc.
Westerville, Ohio, 43082, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Paddington Testing Company, Inc.
Philadelphia, Pennsylvania, 19103, United States
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407, United States
Rivergate Dermatology Clinical Research Center
Goodlettsville, Tennessee, 37072, United States
Bellaire Dermatology Associates
Bellaire, Texas, 77401, United States
Modern Research Associates, PLLC
Dallas, Texas, 75231, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Woden Dermatology Pty Ltd.
Phillip, Australian Capital Territory, 2606, Australia
Skin & Cancer Foundation Australia
Darlinghurst, New South Wales, 2010, Australia
St. George Dermatology and Skin Cancer Center
Kogarah, New South Wales, 2217, Australia
Veracity Clinical Research
Woolloongabba, Queensland, 4102, Australia
Skin & Cancer Foundation Inc.
Carlton, Victoria, 3053, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
Burswood Dermatology
Victoria Park, Western Australia, 6100, Australia
Dr. Chih-ho Hong Medical
Surrey, British Columbia, V3R 6A7, Canada
Enverus Medical Research
Surrey, British Columbia, V3V 0C6, Canada
Pacific Derm
Vancouver, British Columbia, V6H 4E1, Canada
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2, Canada
Wiseman Dermatology Research
Winnipeg, Manitoba, R3M 3Z4, Canada
Brunswick Dermatology Centre
Fredericton, New Brunswick, E3B 1G9, Canada
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
Eastern Canada Cutaneous Research
Halifax, Nova Scotia, B5H 1Z4, Canada
Kingsway Clinical Research
Etobicoke, Ontario, M8X 1Y9, Canada
Guenther Derm Research Centre
London, Ontario, N6A 3H7, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X2, Canada
DermEdge Research
Mississauga, Ontario, L5H 1G9, Canada
Dermatology & Cosmetic Surgery
North Bay, Ontario, P1B 3Z7, Canada
Derm Clinic of Dr. Robern
Ottawa, Ontario, K2G 6E2, Canada
Skin Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
Dermatology & Cosmetic Surgery
Richmond Hill, Ontario, L4B 1A5, Canada
K. Papp
Waterloo, Ontario, N2J 1C4, Canada
XLR8 Medical Research
Windsor, Ontario, N8W 1E6, Canada
Dr. David Gratton Dermatologue
Montreal, Quebec, H3H 1V4, Canada
CRDQ
Québec, Quebec, G1V 4X7, Canada
Aarhus University Hospital
Aarhus, Denmark
Bispebjerg Hospital
Hellerup, Denmark
Gentofte Hospital
Hellerup, Denmark
Spedali Civili Brescia
Brescia, 25123, Italy
Policlinico-Vittorio Emanuele
Catania, 95123, Italy
Opedale San Salvatore
L’Aquila, 67100, Italy
AOU Pisa
Pisa, 56126, Italy
IRCCS San Gallicano
Rome, 00144, Italy
Policlinico "Agostino Gemelli"
Rome, 00168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Centrum Medyczne Gdynia
Gdynia, 81-338, Poland
Synexus Polska Gdyni
Gdynia, 81-384, Poland
Synexus Polska Katowicach
Katowice, 40-040, Poland
Centrum Medyczne PRATIA
Krakow, 30-002, Poland
Krakowskie Centrum Medyczne
Krakow, 31-501, Poland
"DERMED" Centrum Medyczne Sp.
Lodz, 90-265, Poland
Dermoklinika Centrum Medyczne
Lodz, 90-436, Poland
Synexus Polska Poznaniu
Poznan, 60-702, Poland
Klinika Dermatologii
RzeszĂ³w, 35-055, Poland
Chelyabinsk Dermat. Dispensary
Chelyabinsk, 454048, Russia
Federal State Budgetary Institution State Sci. Ctr.
Moscow, 107076, Russia
French clinic of skin diseases
Saint Petersburg, 191123, Russia
Military Medical Academy
Saint Petersburg, 194044, Russia
Pusan National University Hospital
Busan, 49241, South Korea
Chungnam National Univeristy
Daejeon, 35015, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Soon Chun Hyang University Hospital
Gyeonggi-do, 14584, South Korea
Korea University Ansan Hospital
Gyeonggi-do, 425-707, South Korea
St. Mary's Hospital
Incheon, 21431, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Yonsei University Health Syste
Seoul, 03722, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Hallym University Kangnam Sacr
Seoul, 07441, South Korea
Ninewells Hospital
Dundee, Angus, DD2 1GZ, United Kingdom
Salford Royal Hospital
Salford, Greater Manchester, M6 8HD, United Kingdom
Whipps Cross University Hospital
Leytonstone, London, E11 1NR, United Kingdom
Harrogate District Hospital
Harrogate, North Yorkshire, HG2 7SX, United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2RX, United Kingdom
East Surrey Hospital
Redhill, Surrey, RH1 5RH, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom
Russells Hall Hospital
Dudley, West Midlands, DY1 2HQ, United Kingdom
Walsall Healthcare NHS Trust
Walsall, West Midlands, WS2 9PS, United Kingdom
Chapel Allerton Hospital
Leeds, West Yorkshire, LS7 4SA, United Kingdom
West Suffolk Hospital
Bury St Edmunds, IP33 2QZ, United Kingdom
The Whittington Hospital NHS
London, N19 5NF, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Related Publications (7)
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: 40085349DERIVEDSimpson 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: 37682422DERIVEDBlauvelt 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
Eric Simpson, MD, MCR
Department of Dermatology, Oregon Health and Science University
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 investigational medicinal products (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 healthcare professional (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
May 18, 2017
First Posted
May 19, 2017
Study Start
June 12, 2017
Primary Completion
September 4, 2018
Study Completion
August 14, 2019
Last Updated
March 11, 2025
Results First Posted
August 24, 2020
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share