Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2) (ECZTRA 2)

• ClinicalTrials.gov Identifier: NCT03160885
• Recruitment Status: Completed
• First Posted: May 19, 2017
• Results First Posted: August 24, 2020
• Last Update Posted: February 24, 2023
• Sponsor: LEO Pharma
• Information provided by (Responsible Party): LEO Pharma

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: Tralokinumab; Drug: Placebo	Phase 3

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 (Asia, Australia, Europe, and North America) 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 (Asia, Australia, Europe, and North America) 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 794 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)

Masking Description

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.

• Primary Purpose: Treatment
• Official Title: A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
• Actual Study Start Date: June 12, 2017
• Actual Primary Completion Date: September 4, 2018
• Actual Study Completion Date: August 14, 2019

Arms and Interventions

Arm	Intervention/treatment
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; Week 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	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. Participants 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; 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 (tralokinumab naive); 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 300 mg Q2W + 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

Outcome Measures

Primary Outcome Measures :

1. 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).
2. Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI]. [ 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.

Secondary Outcome Measures :

1. 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'.
2. 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 AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
3. Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16. [ 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 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.
4. Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA of 0/1 at Week 16 [ 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).
5. 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.
6. 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.
7. Frequency of Anti-drug Antibodies [ Time Frame: Week 0 to Week 16 ]
   Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method
8. 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.
9. 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.
10. Change From Baseline to Week 16 in Eczema Area and Severity Index [EASI] Score [ 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.
11. 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 AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
12. 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 AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
13. Change From Baseline to Week 16 in Worst Daily Pruritus NRS (Weekly Average). [ Time Frame: Baseline to Week 16 ]
    Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'
14. Reduction of Worst Daily Pruritus NRS (Weekly Average) ≥3 From Baseline to Week 16. [ Time Frame: Baseline to Week 16 ]
    Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
15. Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of ≥4 Points Among Subjects With Baseline DLQI ≥4. [ Time Frame: Baseline 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 (33; 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.

Contacts and Locations

Locations

United States, Arkansas

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States, 71913

United States, California

California dermatology

Encinitas, California, United States, 92024

Advanced SkinCare Surgery & Med Center

Fullerton, California, United States, 92835

USC Department of Dermatology

Los Angeles, California, United States, 90033

Thiele Dermatology Specialists, Inc

Murrieta, California, United States, 92562

Island Dermatology

Newport Beach, California, United States, 92660

Therapeutics Clinical Research

San Diego, California, United States, 92123

San Luis Dermatology and Laser Clinic

San Luis Obispo, California, United States, 93405

Southern California Dermatology, Inc.

Santa Ana, California, United States, 92701

United States, Florida

Olympian Clinical Research

Clearwater, Florida, United States, 33756

Spotlight Research Center, LLC

Miami, Florida, United States, 33176

Private Practice - Dr. Tory P. Sullivan

North Miami Beach, Florida, United States, 33162

United States, Georgia

Marietta Dermatology Clinical Research, Inc.

Marietta, Georgia, United States, 30060

MedaPhase, Inc.

Newnan, Georgia, United States, 30263

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RUSH University

Chicago, Illinois, United States, 60612

United States, Indiana

Dawes-Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States, 46256

United States, Kansas

Kansas City Dermatology, PA

Overland Park, Kansas, United States, 66215

United States, Massachusetts

Beacon Clinical Research

Quincy, Massachusetts, United States, 02169

United States, Michigan

HFMC New Center One

Detroit, Michigan, United States, 48202

The Grekin Skin Institute

Warren, Michigan, United States, 48088

Respiratory Medicine Research Institute of Michigan, PLC

Ypsilanti, Michigan, United States, 48197

United States, Nevada

Clinical Studies Group

Henderson, Nevada, United States, 89074

United States, New Jersey

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States, 08520

United States, New York

Corning Center for Clinical Research

Corning, New York, United States, 14830

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Sadick Dermatology

New York, New York, United States, 10075

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

University of Cincinnati Health Physicians Office

Cincinnati, Ohio, United States, 45267

Wright State Physicians

Fairborn, Ohio, United States, 45324

Aventiv Research Inc.

Westerville, Ohio, United States, 43082

United States, Oregon

Oregon Dermatology and Research Center

Portland, Oregon, United States, 97210

United States, Pennsylvania

Paddington Testing Company, Inc.

Philadelphia, Pennsylvania, United States, 19103

Yardley Dermatology Associates

Yardley, Pennsylvania, United States, 19067

United States, South Carolina

Clinical Research Center of the Carolinas

Charleston, South Carolina, United States, 29407

United States, Tennessee

Rivergate Dermatology Clinical Research Center

Goodlettsville, Tennessee, United States, 37072

United States, Texas

Bellaire Dermatology Associates

Bellaire, Texas, United States, 77401

Modern Research Associates, PLLC

Dallas, Texas, United States, 75231

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, United States, 78660

Progressive Clinical Research

San Antonio, Texas, United States, 78213

Australia, Australian Capital Territory

Woden Dermatology Pty Ltd.

Phillip, Australian Capital Territory, Australia, 2606

Australia, New South Wales

Skin & Cancer Foundation Australia

Darlinghurst, New South Wales, Australia, 2010

St. George Dermatology and Skin Cancer Center

Kogarah, New South Wales, Australia, 2217

Australia, Queensland

Veracity Clinical Research

Woolloongabba, Queensland, Australia, 4102

Australia, Victoria

Skin & Cancer Foundation Inc.

Carlton, Victoria, Australia, 3053

Sinclair Dermatology

East Melbourne, Victoria, Australia, 3002

Australia, Western Australia

Burswood Dermatology

Victoria Park, Western Australia, Australia, 6100

Canada, British Columbia

Dr. Chih-ho Hong Medical

Surrey, British Columbia, Canada, V3R 6A7

Enverus Medical Research

Surrey, British Columbia, Canada, V3V 0C6

Pacific Derm

Vancouver, British Columbia, Canada, V6H 4E1

Canada, Manitoba

Winnipeg Clinic

Winnipeg, Manitoba, Canada, R3C 0N2

Wiseman Dermatology Research

Winnipeg, Manitoba, Canada, R3M 3Z4

Canada, New Brunswick

Brunswick Dermatology Centre

Fredericton, New Brunswick, Canada, E3B 1G9

Canada, Newfoundland and Labrador

Nexus Clinical Research

St. John's, Newfoundland and Labrador, Canada, A1A 5E8

Canada, Nova Scotia

Eastern Canada Cutaneous Research

Halifax, Nova Scotia, Canada, B5H 1Z4

Canada, Ontario

Kingsway Clinical Research

Etobicoke, Ontario, Canada, M8X 1Y9

Guenther Derm Research Centre

London, Ontario, Canada, N6A 3H7

Lynderm Research Inc.

Markham, Ontario, Canada, L3P 1X2

DermEdge Research

Mississauga, Ontario, Canada, L5H 1G9

Dermatology & Cosmetic Surgery

North Bay, Ontario, Canada, P1B 3Z7

Derm Clinic of Dr. Robern

Ottawa, Ontario, Canada, K2G 6E2

Skin Centre for Dermatology

Peterborough, Ontario, Canada, K9J 5K2

Dermatology & Cosmetic Surgery

Richmond Hill, Ontario, Canada, L4B 1A5

K. Papp

Waterloo, Ontario, Canada, N2J 1C4

XLR8 Medical Research

Windsor, Ontario, Canada, N8W 1E6

Canada, Quebec

Dr. David Gratton Dermatologue

Montréal, Quebec, Canada, H3H 1V4

CRDQ

Québec, Quebec, Canada, G1V 4X7

Denmark

Aarhus University Hospital

Aarhus, Denmark

Bispebjerg Hospital

Hellerup, Denmark

Gentofte Hospital

Hellerup, Denmark

Italy

Spedali Civili Brescia

Brescia, Italy, 25123

Policlinico-Vittorio Emanuele

Catania, Italy, 95123

Opedale San Salvatore

L'Aquila, Italy, 67100

AOU Pisa

Pisa, Italy, 56126

IRCCS San Gallicano

Rom, Italy, 00144

Policlinico "Agostino Gemelli"

Rom, Italy, 00168

Istituto Clinico Humanitas

Rozzano, Italy, 20089

Korea, Republic of

Pusan National University Hospital

Busan, Korea, Republic of, 49241

Chungnam National Univeristy

Daejeon, Korea, Republic of, 35015

Chonnam National University Hospital

Gwangju, Korea, Republic of, 61469

Soon Chun Hyang University Hospital

Gyeonggi-do, Korea, Republic of, 14584

Korea University Ansan Hospital

Gyeonggi-do, Korea, Republic of, 425-707

St. Mary's Hospital

Incheon, Korea, Republic of, 21431

Inha University Hospital

Incheon, Korea, Republic of, 22332

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Yonsei University Health Syste

Seoul, Korea, Republic of, 03722

Konkuk University Medical Center

Seoul, Korea, Republic of, 05030

Chung-Ang University Hospital

Seoul, Korea, Republic of, 06973

Hallym University Kangnam Sacr

Seoul, Korea, Republic of, 07441

Poland

Centrum Medyczne Gdynia

Gdynia, Poland, 81-338

Synexus Polska Gdyni

Gdynia, Poland, 81-384

Synexus Polska Katowicach

Katowice, Poland, 40-040

Centrum Medyczne PRATIA

Kraków, Poland, 30-002

Krakowskie Centrum Medyczne

Kraków, Poland, 31-501

Synexus Polska Poznaniu

Poznań, Poland, 60-702

Klinika Dermatologii

Rzeszów, Poland, 35-055

"DERMED" Centrum Medyczne Sp.

Łódź, Poland, 90-265

Dermoklinika Centrum Medyczne

Łódź, Poland, 90-436

Russian Federation

Chelyabinsk Dermat. Dispensary

Chelyabinsk, Russian Federation, 454048

Federal State Budgetary Institution State Sci. Ctr.

Moscow, Russian Federation, 107076

French clinic of skin diseases

Saint Petersburg, Russian Federation, 191123

Military Medical Academy

Saint Petersburg, Russian Federation, 194044

United Kingdom

Ninewells Hospital

Dundee, Angus, United Kingdom, DD2 1GZ

Salford Royal Hospital

Salford, Greater Manchester, United Kingdom, M6 8HD

Whipps Cross University Hospital

Leytonstone, London, United Kingdom, E11 1NR

Harrogate District Hospital

Harrogate, North Yorkshire, United Kingdom, HG2 7SX

Royal Hallamshire Hospital

Sheffield, South Yorkshire, United Kingdom, S10 2RX

East Surrey Hospital

Redhill, Surrey, United Kingdom, RH1 5RH

Royal Victoria Infirmary

Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP

Russells Hall Hospital

Dudley, West Midlands, United Kingdom, DY1 2HQ

Walsall Healthcare NHS Trust

Walsall, West Midlands, United Kingdom, WS2 9PS

Chapel Allerton Hospital

Leeds, West Yorkshire, United Kingdom, LS7 4SA

West Suffolk Hospital

Bury St Edmunds, United Kingdom, IP33 2QZ

The Whittington Hospital NHS

London, United Kingdom, N19 5NF

Guy's Hospital

London, United Kingdom, SE1 9RT

Sponsors and Collaborators

LEO Pharma

Investigators

• Principal Investigator: Eric Simpson, MD, MCR; Department of Dermatology, Oregon Health and Science University

  Study Documents (Full-Text)

Documents provided by LEO Pharma:

Study Protocol  [PDF] August 14, 2018

Statistical Analysis Plan  [PDF] June 14, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Blauvelt A, Gooderham M, Bhatia N, Langley RG, Schneider S, Zoidis J, Kurbasic A, Armstrong A, Silverberg JI. Tralokinumab Efficacy and Safety, with or without Topical Corticosteroids, in North American Adults with Moderate-to-Severe Atopic Dermatitis: A Subanalysis of Phase 3 Trials ECZTRA 1, 2, and 3. Dermatol Ther (Heidelb). 2022 Nov;12(11):2499-2516. doi: 10.1007/s13555-022-00805-y. Epub 2022 Sep 24.

Simpson EL, Merola JF, Silverberg JI, Reich K, Warren RB, Staumont-Salle D, Girolomoni G, Papp K, de Bruin-Weller M, Thyssen JP, Zachariae R, Olsen CK, Wollenberg A. Safety of tralokinumab in adult patients with moderate-to-severe atopic dermatitis: pooled analysis of five randomized, double-blind, placebo-controlled phase II and phase III trials. Br J Dermatol. 2022 Dec;187(6):888-899. doi: 10.1111/bjd.21867. Epub 2022 Oct 26.

Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour JP, Spelman L, Katoh N, Saeki H, Poulin Y, Lesiak A, Kircik L, Cho SH, Herranz P, Cork MJ, Peris K, Steffensen LA, Bang B, Kuznetsova A, Jensen TN, Osterdal ML, Simpson EL; ECZTRA 1 and ECZTRA 2 study investigators. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021 Mar;184(3):437-449. doi: 10.1111/bjd.19574. Epub 2020 Dec 30.

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT03160885
• Other Study ID Numbers: LP0162-1326; 2016-004201-13 ( EudraCT Number )
• First Posted: May 19, 2017
• Results First Posted: August 24, 2020
• Last Update Posted: February 24, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified Individual Participant Data can be made available to researchers in a closed environment for a specified period of time.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: Data are available to request after results of the trial are available on leopharmatrials.com
• Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• URL: http://leopharmatrials.com/for-professionals

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases