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

NCT ID: NCT03131648

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 802 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-30
• Study Completion Date: 2019-10-10

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.

Detailed Description

Subjects found eligible following the screening period were randomized 3:1 to initial treatment with tralokinumab 300 mg every 2 weeks (Q2W) or placebo. Randomization was stratified by region (North America, Europe, and Japan) and disease severity (Investigator's Global Assessment [IGA] 3 or 4).

Subjects achieving a clinical response at Week 16 (defined as IGA of 0 or 1 on a 5-point scale ranging from 0 [clear] to 4 [severe], or at least 75% reduction in Eczema Area and Severity Index [EASI] score from baseline [EASI75]) continued into maintenance treatment that continued until Week 52.

Subjects randomized to tralokinumab in the initial treatment period and who achieved a clinical response at Week 16 (defined by IGA 0 or 1, or EASI75) were re-randomized 2:2:1 to one of the following Q2W maintenance regimens stratified by region (North America, Europe, and Japan) and IGA response at Week 16 (IGA 0/1 or IGA >1):

• Tralokinumab 300 mg Q2W.
• Tralokinumab 300 mg Q4W (alternating dose administrations tralokinumab 300 mg and placebo).
• Placebo (Subjects randomized to placebo in the initial treatment period who achieved a clinical response at Week 16 [defined by IGA 0 or 1, or EASI75] continued to receive placebo Q2W in the maintenance treatment period).

Subjects not achieving a clinical response at Week 16 as well as those who met the criteria listed below during maintenance treatment were transferred to open-label tralokinumab 300 mg Q2W treatment with optional use of topical corticosteroid (TCS) up to Week 52.

Transfer to open-label treatment during maintenance:

Subjects with IGA=0 at Week 16: IGA of at least 2 and not achieved EASI75 over at least a 4-week period (i.e. over 3 consecutive visits).

Subjects with IGA=1 at Week 16: IGA of at least 3 and not achieved EASI75 over at least a 4-week period (i.e. over 3 consecutive visits).

Subjects with IGA >1 at Week 16: not achieved EASI75 over at least a 4-week period (i.e. over 3 consecutive visits).

Subjects transferring to open-label treatment had the option to self-administer tralokinumab in their home after adequate training (at 3 dosing visits in the open-label period after additional consent has been obtained) by site staff at the investigator's discretion.

After completion of the maintenance treatment period (or open-label treatment), all subjects, except for those who entered the open-label long-term extension trial, continued in a 14-week off-treatment follow-up period for the assessment of safety and anti-drug antibody (ADA).

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tralokinumab

Intervention Type: DRUG

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

Initial treatment period - Placebo Q2W

Week 0 to Week 16:

Two subcutaneous (SC) injections of placebo as a loading dose on Day 0 followed by a SC injection of placebo Q2W regimen for 16 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Tralokinumab

Intervention Type: DRUG

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

Maintenance treatment period - Tralokinumab Q4W

Week 16 to Week 52:

Tralokinumab responders from the initial treatment period re-randomised at Week 16 and administered tralokinumab maintenance subcutaneous injection regimen Q4W for 36 weeks.

Subjects in this group receive alternating doses of tralokinumab SC injection and placebo SC injection every 2 weeks.

Group Type: EXPERIMENTAL

Tralokinumab

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Maintenance treatment period - Placebo Q2W

Week 16 to Week 52:

Tralokinumab responders from initial treatment period randomised at Week 16 and administered placebo subcutaneous maintenance injection for 36 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Maintenance treatment period - Placebo

Week 16 to Week 52:

Placebo responders from the initial treatment period re-assigned at Week 16 and administered placebo maintenance subcutaneous injection regimen Q2W for 36 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Open-label treatment - Tralokinumab + optional TCS

Week 16 to Week 52:

Subjects receiving initial treatment with tralokinumab Q2W or placebo Q2W assigned to open-label treatment at Week 16 and administered Tralokinumab subcutaneous (SC) injection + optional TCS* regimen Q2W.

OR

Subjects receiving maintenance treatment with tralokinumab Q2W/Q4W or placebo assigned to open-label treatment after Week 16 and administered tralokinumab SC injection + optional TCS* regimen Q2W.

*TCS = topical corticosteroids.

Group Type: EXPERIMENTAL

Tralokinumab

Intervention Type: DRUG

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

Open-label short-term- Tralokinumab + optional TCS

Week 52 to Week 68 [Short term extension (Japan only)] :

Japanese subjects who were transferred to the open-label tralokinumab Q2W arm at Week 16 continued an additional 16 weeks (Week 52 to Week 66) of open-label treatment to receive 52 weeks of active therapy.

Group Type: EXPERIMENTAL

Tralokinumab

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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 (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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Wollenberg, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology and Allergy, Ludwig-Maximilian University Munich, Germany

Locations

Clinical Research Center of Alabama

Birmingham, Alabama, United States

Tien Q. Nguyen, MD, Inc.

Fountain Valley, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Quest Dermatology Research

Northridge, California, United States

Dermatology Specialists, Inc.

Oceanside, California, United States

Center for Dermatology and Laser Surgery

Sacramento, California, United States

University Clinical Trials, Inc.

San Diego, California, United States

The GWU Medical Faculty Associates

Washington D.C., District of Columbia, United States

Skin Care Research, Inc.

Boca Raton, Florida, United States

Park Avenue Dermatology

Orange Park, Florida, United States

Forward Clinical Trials

Tampa, Florida, United States

Research Institute of the Southeast, LLC

West Palm Beach, Florida, United States

ACRC Dermatology

West Palm Beach, Florida, United States

Georgia Pollens Clinical Research Centers, Inc.

Albany, Georgia, United States

Allergy Center at Brookstone Research

Columbus, Georgia, United States

Dermatologic Surgery Specialists

Macon, Georgia, United States

Meridian Clinical Research

Savannah, Georgia, United States

Altman Dermatology Associates

Arlington Heights, Illinois, United States

PMG Research of Christie Clinic

Chicago, Illinois, United States

Deaconess Clinic

Evansville, Indiana, United States

Skin Sciences, PLLC

Louisville, Kentucky, United States

Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, United States

DermAssociates, PC

Rockville, Maryland, United States

Clarkston Skin Research

Clarkston, Michigan, United States

Derm Center

Troy, Michigan, United States

MediSearch LLC

Saint Joseph, Missouri, United States

JDR Dermatology Research

Las Vegas, Nevada, United States

University at Buffalo Department of Dermatology

Buffalo, New York, United States

Weil Cornell Medicine

New York, New York, United States

Juva Skin & Laser Center

New York, New York, United States

Deramatology Consulting Services, PLLC

High Point, North Carolina, United States

Dermatologists of Greater Columbus

Bexley, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Oregon Medical Research Center

Portland, Oregon, United States

Oregon Health & Sciences University

Portland, Oregon, United States

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, United States

Austin Dermatology Associates

Austin, Texas, United States

Tekton Research

Austin, Texas, United States

Dermtology Treatment and Research Center

Dallas, Texas, United States

Houston Skin Associates

Houston, Texas, United States

Center for Clinical Studies

Webster, Texas, United States

Virginia Clinical Research

Norfolk, Virginia, United States

Dermatology Associates of Seattle

Seattle, Washington, United States

West Virginia Research Institute

Morgantown, West Virginia, 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, , 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, 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, Japan

Hyogo College Of Medicine Hospital

Hyōgo, Nishinomiya, Japan

KUME Clinic

Sakai, Osaka, Japan

NTT Medical Center Tokyo

Tokyo, Shinagawa, Japan

Asahikawa City Hospital

Asahikawa, , Japan

JR Sapporo Hospital

Chūō, , Japan

Medical Corporation Kojinkai

Chūō, , Japan

Fukuoka University Hospital

Fukuoka, , Japan

Kurume University Hospital

Fukuoka, , Japan

Fukushima Medical University Hospital

Fukushima, , Japan

Gifu University Hospital

Gifu, , Japan

Osaka Habikono Medical Center

Habikino, , Japan

Hamamatsu University hospital

Hamamatsu, , 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

Ōsaka, , Japan

Osaka Hospital

Ōsaka, , Japan

Jichi Medical University Hospital

Tochigi, , Japan

Tokyo Teishin Hospital

Tokyo, , Japan

The Jikei University Hospital

Tokyo, , Japan

Nippon Medical School Hospital

Tokyo, , Japan

The Fraternity Memorial Hospital

Tokyo, , Japan

Tokyo Medical University Hospital

Tokyo, , Japan

Ogikubo Hospital

Tokyo, , Japan

Shirasaki Dermatology Clinic

Tōyama, , 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

Countries

United States; France; Germany; Japan; Spain

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Provided Documents

Document Type: Study Protocol

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Document Type: Statistical Analysis Plan

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Other Identifiers

2016-004200-65

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LP0162-1325

Identifier Type: -

Identifier Source: org_study_id