Clinical trial NCT03131648: Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2017-04-27
Enrollment: 802
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
timeFrame: At Week 16
measure: Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 16
timeFrame: At Week 16
Secondary outcomes:
measure: Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16.
timeFrame: Week 0 to Week 16
measure: Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16
timeFrame: Week 0 to Week 16
measure: Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16
timeFrame: Week 0 to Week 16
measure: 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
timeFrame: At Week 52
measure: Subjects With at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 52 Among Subjects With EASI75 at Week 16
timeFrame: At Week 52
measure: Safety and Tolerability: Adverse Event (AE) /Serious Adverse Event (SAE) Frequency
timeFrame: Week 0 to Week 16
measure: Frequency of Anti-drug Antibodies
timeFrame: Week 0 to Week 16
measure: Subjects Achieving at Least 50% Reduction in Eczema Area and Severity Index [EASI] at Week 16
timeFrame: At Week 16
measure: Subjects Achieving at Least 90% Reduction in Eczema Area and Severity Index [EASI] at Week 16
timeFrame: At Week 16
measure: Change From Baseline to Week 16 in Eczema Area and Severity Index [EASI] Score
timeFrame: Week 0 to Week 16
measure: Subjects Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16
timeFrame: At Week 16
measure: Subjects Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16
timeFrame: At Week 16
measure: Change From Baseline to Week 16 in Worst Daily Pruritus NRS (Weekly Average)
timeFrame: Week 0 to Week 16
measure: Reduction of Worst Daily Pruritus NRS (Weekly Average) ≥3 From Baseline to Week 16
timeFrame: Week 0 to Week 16
measure: Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of ≥4 Points Among Subjects With Baseline DLQI ≥4
timeFrame: Week 0 to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Fountain Valley
country: United States
facility: Tien Q. Nguyen, MD, Inc.
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Northridge
country: United States
facility: Quest Dermatology Research
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: Sacramento
country: United States
facility: Center for Dermatology and Laser Surgery
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc.
state: California
city: Washington
country: United States
facility: The GWU Medical Faculty Associates
state: District of Columbia
city: Boca Raton
country: United States
facility: Skin Care Research, Inc.
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Tampa
country: United States
facility: Forward Clinical Trials
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC
state: Florida
city: West Palm Beach
country: United States
facility: ACRC Dermatology
state: Florida
city: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers, Inc.
state: Georgia
city: Columbus
country: United States
facility: Allergy Center at Brookstone Research
state: Georgia
city: Macon
country: United States
facility: Dermatologic Surgery Specialists
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Chicago
country: United States
facility: PMG Research of Christie Clinic
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic
state: Indiana
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
city: Lake Charles
country: United States
facility: Clinical Trials of SWLA, LLC
state: Louisiana
city: Rockville
country: United States
facility: DermAssociates, PC
state: Maryland
city: Clarkston
country: United States
facility: Clarkston Skin Research
state: Michigan
city: Troy
country: United States
facility: Derm Center
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch LLC
state: Missouri
city: Las Vegas
country: United States
facility: JDR Dermatology Research
state: Nevada
city: Buffalo
country: United States
facility: University at Buffalo Department of Dermatology
state: New York
city: New York
country: United States
facility: Weil Cornell Medicine
state: New York
city: New York
country: United States
facility: Juva Skin & Laser Center
state: New York
city: High Point
country: United States
facility: Deramatology Consulting Services, PLLC
state: North Carolina
city: Bexley
country: United States
facility: Dermatologists of Greater Columbus
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Department of Dermatology
state: Pennsylvania
city: Austin
country: United States
facility: Austin Dermatology Associates
state: Texas
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Dallas
country: United States
facility: Dermtology Treatment and Research Center
state: Texas
city: Houston
country: United States
facility: Houston Skin Associates
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates of Seattle
state: Washington
city: Morgantown
country: United States
facility: West Virginia Research Institute
state: West Virginia
city: Valence
country: France
facility: Centre Hospitalier de Valence
state: Drôme
city: Bordeaux
country: France
facility: Hôpital St ANDRE, CHU de BORDEAUX, Service de Dermatologie
city: Brest Cedex
country: France
facility: CHRU de Brest - Hôpital Morvan, Service de Dermatologie
city: Dijon
country: France
facility: CHU de Dijon, Service de Dermatologie
city: Lille Cedex
country: France
facility: Hôpital Saint vincent de paul, Clinique de Dermatologie
city: Lille
country: France
facility: Hôpital Claude Huriez-CHRU, Service de dermatologie
city: Martigues
country: France
facility: Cabinet Médical, Le Bateau Blanc-Immeuble A
city: Mulhouse
country: France
facility: GHRMSA, Service de Dermatologie
city: Nantes
country: France
facility: Centre Hospitalier Universitaire, Clinique dermatologique 7 eme nord
city: Nice
country: France
facility: Hôpital de l'Archet II, Service de Dermatologie- Vénérologie
city: Reims
country: France
facility: Hôpital Robert Debré, Service de Dermatologie
city: Rouen
country: France
facility: Hôpital Charles Nicolle, Clinique Dermatologique
city: Saint-Etienne Cedex 2
country: France
facility: C.H.U. de Saint-Etienne - Hôpital Nord, Service de dermatologie
city: Toulouse
country: France
facility: CHU de Toulouse Hôpital Larrey, Service de Dermatologie
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center Friedrichshafen GmbH
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Klinikum Augsburg, Klinik für Dermatologie und Allergologie
state: Bavaria
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Hautklinik
state: Bavaria
city: München
country: Germany
facility: LMU München, Klinik und Poliklinik für Dermatologie und Allergologie
state: Bavaria
city: Mahlow
country: Germany
facility: Facharztpraxis für Dermatologie, Allergologie, Venerologie und Umweltmedizin
state: Brandenburg
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH, Hautklinik
state: Hessia
city: Hannöver
country: Germany
facility: Hautärzte Zentrum Hannover
state: Lower Saxony
city: Hannöver
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für Dermatologie, Allergologie und Venerologie
state: Lower Saxony
city: Osnabrück
country: Germany
facility: KliFOs - Klinische Forschung Osnabrück
state: Lower Saxony
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld Rosenhöhe, Hautklinik
state: NRW
city: Bochum
country: Germany
facility: Niesmann, Hautzentrum im Jahrhunderthaus
state: NRW
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn, Klinik und Poliklinik für Dermatologie und Allergologie
state: NRW
city: Dülmen
country: Germany
facility: Hautzentrum Dülmen
state: NRW
city: Essen
country: Germany
facility: Universitätsklinikum Essen (AöR), Klinik für Dermatologie, Venerologie und Allergologie
state: NRW
city: Münster
country: Germany
facility: Universitätsklinikum Münster Klinik und Poliklinik für Hautkrankheiten Münster, Zentrale Studienkoordination für innovative Dermatologie
state: NRW
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Dermatologie und Venerologie
state: Saxony-Anhalt
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Dermatologie
state: Saxony
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
state: Saxony
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera, Klinik für klinische Studien
state: Thuringia
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Klinik für Dermatologie, Allergologie und Venerologie
city: Berlin
country: Germany
facility: CMB Collegium Medicum Berlin GmbH
city: Hamburg
country: Germany
facility: SCIderm GmbH
city: Hyōgo
country: Japan
facility: Meiwa Hospital
state: Nishinomiya
city: Hyōgo
country: Japan
facility: Hyogo College Of Medicine Hospital
state: Nishinomiya
city: Sakai City
country: Japan
facility: KUME Clinic
state: Osaka
city: Tokyo
country: Japan
facility: NTT Medical Center Tokyo
state: Shinagawa
city: Asahikawa
country: Japan
facility: Asahikawa City Hospital
city: Chūō
country: Japan
facility: JR Sapporo Hospital
city: Chūō
country: Japan
facility: Medical Corporation Kojinkai
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Gifu-shi
country: Japan
facility: Gifu University Hospital
city: Habikino
country: Japan
facility: Osaka Habikono Medical Center
city: Hamamatsu
country: Japan
facility: Hamamatsu University hospital
city: Ichinomiya
country: Japan
facility: Ichinomiya Municipal Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kyoto
country: Japan
facility: Kyoto Prefectural Hospital
city: Morioka
country: Japan
facility: Iwate Prefectural Central Hospital
city: Nagoya
country: Japan
facility: Chukyo Hospital
city: Obihiro
country: Japan
facility: Takagi Dermatological Clinic
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokyo
country: Japan
facility: Tokyo Teishin Hospital
city: Tokyo
country: Japan
facility: The Jikei University Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: The Fraternity Memorial Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Ogikubo Hospital
city: Tōyama
country: Japan
facility: Shirasaki Dermatology Clinic
city: Ōsaka
country: Japan
facility: Gokeikai Osaka Kaisei Hospital
city: Ōsaka
country: Japan
facility: Osaka Hospital
city: Córdoba
country: Spain
facility: Hospital Reina Sofía, Servicio Dermatología
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena, Servicio Dermatología
state: Andalucía
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol, Servicio Dermatología
state: Catalunya
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona, Dermatology Department
state: Catalunya
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau, Servicio Dermatología
state: Catalunya
city: Barcelona
country: Spain
facility: Hospital del Mar, Servicio Dermatología
state: Catalunya
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra, Servicio Dermatología
state: Navarra
city: Bilbao
country: Spain
facility: Hospital de Basurto, Servicio Dermatología
state: País Vasco
city: Bilbao
country: Spain
facility: Hospital de Cruces, Servicio Dermatología
state: País Vasco
city: Madrid
country: Spain
facility: Hospital de Fuenlabrada, Servicio Dermatología
city: Madrid
country: Spain
facility: Hospital Infanta Leonor, Servicio Dermatología
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa, Servicio Dermatología
city: Madrid
country: Spain
facility: Hospital Universitario La Paz, Servicio Dermatología
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe, Servicio Dermatología
Study officials:
affiliation: Department of Dermatology and Allergy, Ludwig-Maximilian University Munich, Germany
name: Andreas Wollenberg, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.