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

Atopic Dermatitis Clinical Trial

— ECZTRA 1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131648
• Other study ID #: LP0162-1325
• Secondary ID: 2016-004200-65
• Status: Completed
• Phase: Phase 3
• Start date: May 30, 2017
• Est. completion date: October 10, 2019

Study information

• Verified date: February 2023
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary objective:

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

Secondary objectives:

To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo.

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 802
• Est. completion date: October 10, 2019
• Est. primary completion date: August 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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
Placebo contains the same excipients, in the same concentration only lacking tralokinumab

Locations

Country	Name	City	State
France	Hôpital St ANDRE, CHU de BORDEAUX, Service de Dermatologie	Bordeaux
France	CHRU de Brest - Hôpital Morvan, Service de Dermatologie	Brest Cedex
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 Cedex
France	Cabinet Médical, Le Bateau Blanc-Immeuble A	Martigues
France	GHRMSA, Service de Dermatologie	Mulhouse
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 Cedex 2
France	CHU de Toulouse Hôpital Larrey, Service de Dermatologie	Toulouse
France	Centre Hospitalier de Valence	Valence	Drôme
Germany	Klinikum Augsburg, Klinik für Dermatologie und Allergologie	Augsburg	Bavaria
Germany	Charité - Universitätsmedizin Berlin, Klinik für Dermatologie, Allergologie und Venerologie	Berlin
Germany	CMB Collegium Medicum Berlin GmbH	Berlin
Germany	Klinikum Bielefeld Rosenhöhe, Hautklinik	Bielefeld	NRW
Germany	Niesmann, Hautzentrum im Jahrhunderthaus	Bochum	NRW
Germany	Universitätsklinikum Bonn, Klinik und Poliklinik für Dermatologie und Allergologie	Bonn	NRW
Germany	Klinikum Darmstadt GmbH, Hautklinik	Darmstadt	Hessia
Germany	Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Dermatologie	Dresden	Saxony
Germany	Hautzentrum Dülmen	Dülmen	NRW
Germany	Universitätsklinikum Erlangen, Hautklinik	Erlangen	Bavaria
Germany	Universitätsklinikum Essen (AöR), Klinik für Dermatologie, Venerologie und Allergologie	Essen	NRW
Germany	Derma-Study-Center Friedrichshafen GmbH	Friedrichshafen	Baden-Württemberg
Germany	SRH Wald-Klinikum Gera, Klinik für klinische Studien	Gera	Thuringia
Germany	Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Dermatologie und Venerologie	Halle (Saale)	Saxony-Anhalt
Germany	SCIderm GmbH	Hamburg
Germany	Hautärzte Zentrum Hannover	Hannöver	Lower Saxony
Germany	Medizinische Hochschule Hannover, Klinik für Dermatologie, Allergologie und Venerologie	Hannöver	Lower Saxony
Germany	Universitätsklinikum Leipzig, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie	Leipzig	Saxony
Germany	Facharztpraxis für Dermatologie, Allergologie, Venerologie und Umweltmedizin	Mahlow	Brandenburg
Germany	LMU München, Klinik und Poliklinik für Dermatologie und Allergologie	München	Bavaria
Germany	Universitätsklinikum Münster Klinik und Poliklinik für Hautkrankheiten Münster, Zentrale Studienkoordination für innovative Dermatologie	Münster	NRW
Germany	KliFOs - Klinische Forschung Osnabrück	Osnabrück	Lower Saxony
Japan	Asahikawa City Hospital	Asahikawa
Japan	JR Sapporo Hospital	Chuo
Japan	Medical Corporation Kojinkai	Chuo
Japan	Fukuoka University Hospital	Fukuoka
Japan	Kurume University Hospital	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Gifu University Hospital	Gifu-shi
Japan	Osaka Habikono Medical Center	Habikino
Japan	Hamamatsu University hospital	Hamamatsu
Japan	Hyogo College Of Medicine Hospital	Hyogo	Nishinomiya
Japan	Meiwa Hospital	Hyogo	Nishinomiya
Japan	Ichinomiya Municipal Hospital	Ichinomiya
Japan	Kagoshima University Hospital	Kagoshima
Japan	Kyoto Prefectural Hospital	Kyoto
Japan	Iwate Prefectural Central Hospital	Morioka
Japan	Chukyo Hospital	Nagoya
Japan	Takagi Dermatological Clinic	Obihiro
Japan	Gokeikai Osaka Kaisei Hospital	Osaka
Japan	Osaka Hospital	Osaka
Japan	KUME Clinic	Sakai City	Osaka
Japan	Jichi Medical University Hospital	Tochigi
Japan	Nippon Medical School Hospital	Tokyo
Japan	NTT Medical Center Tokyo	Tokyo	Shinagawa
Japan	Ogikubo Hospital	Tokyo
Japan	The Fraternity Memorial Hospital	Tokyo
Japan	The Jikei University Hospital	Tokyo
Japan	Tokyo Medical University Hospital	Tokyo
Japan	Tokyo Teishin Hospital	Tokyo
Japan	Shirasaki Dermatology Clinic	Toyama
Spain	Hospital Germans Trias i Pujol, Servicio Dermatología	Badalona	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	Barcelona	Catalunya
Spain	Hospital de Basurto, Servicio Dermatología	Bilbao	País Vasco
Spain	Hospital de Cruces, Servicio Dermatología	Bilbao	País Vasco
Spain	Hospital Reina Sofía, Servicio Dermatología	Córdoba	Andalucía
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	Clínica Universitaria de Navarra, Servicio Dermatología	Pamplona	Navarra
Spain	Hospital Virgen de la Macarena, Servicio Dermatología	Sevilla	Andalucía
Spain	Hospital Universitario y Politécnico La Fe, Servicio Dermatología	Valencia
United States	Georgia Pollens Clinical Research Centers, Inc.	Albany	Georgia
United States	Altman Dermatology Associates	Arlington Heights	Illinois
United States	Austin Dermatology Associates	Austin	Texas
United States	Tekton Research	Austin	Texas
United States	Dermatologists of Greater Columbus	Bexley	Ohio
United States	Clinical Research Center of Alabama	Birmingham	Alabama
United States	Skin Care Research, Inc.	Boca Raton	Florida
United States	University at Buffalo Department of Dermatology	Buffalo	New York
United States	PMG Research of Christie Clinic	Chicago	Illinois
United States	Clarkston Skin Research	Clarkston	Michigan
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Allergy Center at Brookstone Research	Columbus	Georgia
United States	Dermtology Treatment and Research Center	Dallas	Texas
United States	Deaconess Clinic	Evansville	Indiana
United States	Tien Q. Nguyen, MD, Inc.	Fountain Valley	California
United States	Deramatology Consulting Services, PLLC	High Point	North Carolina
United States	Houston Skin Associates	Houston	Texas
United States	Clinical Trials of SWLA, LLC	Lake Charles	Louisiana
United States	JDR Dermatology Research	Las Vegas	Nevada
United States	Dermatology Research Associates	Los Angeles	California
United States	Skin Sciences, PLLC	Louisville	Kentucky
United States	Dermatologic Surgery Specialists	Macon	Georgia
United States	West Virginia Research Institute	Morgantown	West Virginia
United States	Juva Skin & Laser Center	New York	New York
United States	Weil Cornell Medicine	New York	New York
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Quest Dermatology Research	Northridge	California
United States	Dermatology Specialists, Inc.	Oceanside	California
United States	Park Avenue Dermatology	Orange Park	Florida
United States	UPMC Department of Dermatology	Pittsburgh	Pennsylvania
United States	Oregon Health & Sciences University	Portland	Oregon
United States	Oregon Medical Research Center	Portland	Oregon
United States	DermAssociates, PC	Rockville	Maryland
United States	Center for Dermatology and Laser Surgery	Sacramento	California
United States	MediSearch LLC	Saint Joseph	Missouri
United States	University Clinical Trials, Inc.	San Diego	California
United States	Meridian Clinical Research	Savannah	Georgia
United States	Dermatology Associates of Seattle	Seattle	Washington
United States	Forward Clinical Trials	Tampa	Florida
United States	Derm Center	Troy	Michigan
United States	The GWU Medical Faculty Associates	Washington	District of Columbia
United States	Center for Clinical Studies	Webster	Texas
United States	ACRC Dermatology	West Palm Beach	Florida
United States	Research Institute of the Southeast, LLC	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

United States,  France,  Germany,  Japan,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16.	Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.	Week 0 to Week 16
Secondary	Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16	The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with higher values indicating a more extensive and/or severe condition.	Week 0 to Week 16
Secondary	Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16	The Dermatology Life Quality Index (DLQI) is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life (QoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all /not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.	Week 0 to Week 16
Secondary	Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA of 0/1 at Week 16	The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).	At Week 52
Secondary	Subjects With at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 52 Among Subjects With EASI75 at Week 16	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.	At Week 52
Secondary	Safety and Tolerability: Adverse Event (AE) /Serious Adverse Event (SAE) Frequency	Overall summary of AEs and SAEs during the Initial treatment period is presented. For list of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the entire trial period (including safety follow-up), see Adverse Events Overview section.	Week 0 to Week 16
Secondary	Frequency of Anti-drug Antibodies	Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.	Week 0 to Week 16
Secondary	Subjects Achieving at Least 50% Reduction in Eczema Area and Severity Index [EASI] at Week 16	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.	At Week 16
Secondary	Subjects Achieving at Least 90% Reduction in Eczema Area and Severity Index [EASI] at Week 16	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.	At Week 16
Secondary	Change From Baseline to Week 16 in Eczema Area and Severity Index [EASI] Score	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.	Week 0 to Week 16
Secondary	Subjects Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16	The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.	At Week 16
Secondary	Subjects Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16	The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with higher values indicating a more extensive and/or severe condition.	At Week 16
Secondary	Change From Baseline to Week 16 in Worst Daily Pruritus NRS (Weekly Average)	Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'	Week 0 to Week 16
Secondary	Reduction of Worst Daily Pruritus NRS (Weekly Average) =3 From Baseline to Week 16	Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.	Week 0 to Week 16
Secondary	Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of =4 Points Among Subjects With Baseline DLQI =4	The DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their QoL over the last week such as dermatology related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.	Week 0 to Week 16