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

PHASE3CompletedINTERVENTIONAL
Enrollment

802

Participants

Timeline

Start Date

May 30, 2017

Primary Completion Date

August 7, 2018

Study Completion Date

October 10, 2019

Conditions
Atopic Dermatitis
Interventions
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

Trial Locations (123)

10021

Weil Cornell Medicine, New York

10022

Juva Skin & Laser Center, New York

14203

University at Buffalo Department of Dermatology, Buffalo

15213

UPMC Department of Dermatology, Pittsburgh

20037

The GWU Medical Faculty Associates, Washington D.C.

20850

DermAssociates, PC, Rockville

23502

Virginia Clinical Research, Norfolk

26505

West Virginia Research Institute, Morgantown

27262

Deramatology Consulting Services, PLLC, High Point

30159

Hautärzte Zentrum Hannover, Hannover

31217

Dermatologic Surgery Specialists, Macon

31406

Meridian Clinical Research, Savannah

31707

Georgia Pollens Clinical Research Centers, Inc., Albany

31904

Allergy Center at Brookstone Research, Columbus

32073

Park Avenue Dermatology, Orange Park

33401

Research Institute of the Southeast, LLC, West Palm Beach

33406

ACRC Dermatology, West Palm Beach

33486

Skin Care Research, Inc., Boca Raton

33624

Forward Clinical Trials, Tampa

35209

Clinical Research Center of Alabama, Birmingham

40217

Skin Sciences, PLLC, Louisville

43209

Dermatologists of Greater Columbus, Bexley

44106

University Hospitals Cleveland Medical Center, Cleveland

47713

Deaconess Clinic, Evansville

48084

Derm Center, Troy

48346

Clarkston Skin Research, Clarkston

60005

Altman Dermatology Associates, Arlington Heights

61820

PMG Research of Christie Clinic, Chicago

64506

MediSearch LLC, Saint Joseph

68100

GHRMSA, Service de Dermatologie, Mulhouse

70601

Clinical Trials of SWLA, LLC, Lake Charles

75230

Dermtology Treatment and Research Center, Dallas

77004

Houston Skin Associates, Houston

77958

Center for Clinical Studies, Webster

78705

Austin Dermatology Associates, Austin

78745

Tekton Research, Austin

89148

JDR Dermatology Research, Las Vegas

90045

Dermatology Research Associates, Los Angeles

91324

Quest Dermatology Research, Northridge

92056

Dermatology Specialists, Inc., Oceanside

92123

University Clinical Trials, Inc., San Diego

92708

Tien Q. Nguyen, MD, Inc., Fountain Valley

95819

Center for Dermatology and Laser Surgery, Sacramento

97223

Oregon Medical Research Center, Portland

97239

Oregon Health & Sciences University, Portland

98101

Dermatology Associates of Seattle, Seattle

Unknown

Centre Hospitalier de Valence, Valence

Hôpital St ANDRE, CHU de BORDEAUX, Service de Dermatologie, Bordeaux

CHRU de Brest - Hôpital Morvan, Service de Dermatologie, Brest

CHU de Dijon, Service de Dermatologie, Dijon

Hôpital Claude Huriez-CHRU, Service de dermatologie, Lille

Hôpital Saint vincent de paul, Clinique de Dermatologie, Lille

Cabinet Médical, Le Bateau Blanc-Immeuble A, Martigues

Centre Hospitalier Universitaire, Clinique dermatologique 7 eme nord, Nantes

Hôpital de l'Archet II, Service de Dermatologie- Vénérologie, Nice

Hôpital Robert Debré, Service de Dermatologie, Reims

Hôpital Charles Nicolle, Clinique Dermatologique, Rouen

C.H.U. de Saint-Etienne - Hôpital Nord, Service de dermatologie, Saint-Etienne

CHU de Toulouse Hôpital Larrey, Service de Dermatologie, Toulouse

Derma-Study-Center Friedrichshafen GmbH, Friedrichshafen

Klinikum Augsburg, Klinik für Dermatologie und Allergologie, Augsburg

Universitätsklinikum Erlangen, Hautklinik, Erlangen

LMU München, Klinik und Poliklinik für Dermatologie und Allergologie, München

Facharztpraxis für Dermatologie, Allergologie, Venerologie und Umweltmedizin, Mahlow

Klinikum Darmstadt GmbH, Hautklinik, Darmstadt

Medizinische Hochschule Hannover, Klinik für Dermatologie, Allergologie und Venerologie, Hannover

KliFOs - Klinische Forschung Osnabrück, Osnabrück

Klinikum Bielefeld Rosenhöhe, Hautklinik, Bielefeld

Niesmann, Hautzentrum im Jahrhunderthaus, Bochum

Universitätsklinikum Bonn, Klinik und Poliklinik für Dermatologie und Allergologie, Bonn

Hautzentrum Dülmen, Dülmen

Universitätsklinikum Essen (AöR), Klinik für Dermatologie, Venerologie und Allergologie, Essen

Universitätsklinikum Münster Klinik und Poliklinik für Hautkrankheiten Münster, Zentrale Studienkoordination für innovative Dermatologie, Münster

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Dermatologie, Dresden

Universitätsklinikum Leipzig, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Leipzig

Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Dermatologie und Venerologie, Halle

SRH Wald-Klinikum Gera, Klinik für klinische Studien, Gera

Charité - Universitätsmedizin Berlin, Klinik für Dermatologie, Allergologie und Venerologie, Berlin

CMB Collegium Medicum Berlin GmbH, Berlin

SCIderm GmbH, Hamburg

Takagi Dermatological Clinic, Obihiro

Hospital Reina Sofía, Servicio Dermatología, Córdoba

Hospital Virgen de la Macarena, Servicio Dermatología, Seville

Hospital de Basurto, Servicio Dermatología, Bilbao

Hospital de Cruces, Servicio Dermatología, Bilbao

Hospital Germans Trias i Pujol, Servicio Dermatología, Badalona

Hospital Clinic de Barcelona, Dermatology Department, Barcelona

Hospital de la Santa Creu i Sant Pau, Servicio Dermatología, Barcelona

Hospital del Mar, Servicio Dermatología, Barcelona

Clínica Universitaria de Navarra, Servicio Dermatología, Pamplona

Hospital de Fuenlabrada, Servicio Dermatología, Madrid

Hospital Infanta Leonor, Servicio Dermatología, Madrid

Hospital Universitario de la Princesa, Servicio Dermatología, Madrid

Hospital Universitario La Paz, Servicio Dermatología, Madrid

Hospital Universitario y Politécnico La Fe, Servicio Dermatología, Valencia

663-8186

Meiwa Hospital, Hyōgo

663-8501

Hyogo College Of Medicine Hospital, Hyōgo

593-8324

KUME Clinic, Sakai

141-8625

NTT Medical Center Tokyo, Tokyo

070-8610

Asahikawa City Hospital, Asahikawa

060-0033

JR Sapporo Hospital, Chūō

060-0063

Medical Corporation Kojinkai, Chūō

814-0180

Fukuoka University Hospital, Fukuoka

830-0011

Kurume University Hospital, Fukuoka

960-1295

Fukushima Medical University Hospital, Fukushima

315-0974

Gifu University Hospital, Gifu

583-8588

Osaka Habikono Medical Center, Habikino

431-3192

Hamamatsu University hospital, Hamamatsu

491-8558

Ichinomiya Municipal Hospital, Ichinomiya

890-8520

Kagoshima University Hospital, Kagoshima

602-8566

Kyoto Prefectural Hospital, Kyoto

020-0066

Iwate Prefectural Central Hospital, Morioka

457-8510

Chukyo Hospital, Nagoya

532-0003

Gokeikai Osaka Kaisei Hospital, Ōsaka

553-0003

Osaka Hospital, Ōsaka

329-0498

Jichi Medical University Hospital, Tochigi

102-8798

Tokyo Teishin Hospital, Tokyo

105-8471

The Jikei University Hospital, Tokyo

113-8603

Nippon Medical School Hospital, Tokyo

130-8587

The Fraternity Memorial Hospital, Tokyo

160-0023

Tokyo Medical University Hospital, Tokyo

167-0035

Ogikubo Hospital, Tokyo

933-0871

Shirasaki Dermatology Clinic, Tōyama

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LEO Pharma

INDUSTRY

NCT03131648 - Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1) | Biotech Hunter | Biotech Hunter