Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
NCT ID: NCT03587805
Last Updated: 2025-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1672 participants
INTERVENTIONAL
2018-03-18
2024-07-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tralokinumab, all subjects
Week 0: subcutaneous (SC) injection of tralokinumab loading dose. From Week 2 up to Week 266: SC injection of tralokinumab maintenance dose. The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.
Tralokinumab
Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
Interventions
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Tralokinumab
Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
Eligibility Criteria
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Inclusion Criteria
* Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
* Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial).
* Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
Exclusion Criteria
* More than 26 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial (to be assessed at baseline).
* Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
* Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to baseline.
* Treatment with topical phosphodiesterase 4 inhibitors or topical JAK inhibitors within 2 weeks prior to baseline.
* Clinically significant infection within 4 weeks prior to baseline.
* A helminth parasitic infection within 6 months prior to the date when informed consent is obtained.
* Tuberculosis requiring treatment within 12 months prior to screening.
* Known primary immunodeficiency disorder.
12 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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Fukuoka, Fukuoka, Japan
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Fort Smith, Arkansas, United States
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Bakersfield, California, United States
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Beverly Hills, California, United States
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Encinitas, California, United States
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Fountain Valley, California, United States
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Fremont, California, United States
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Fullerton, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Palo Alto, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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San Luis Obispo, California, United States
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Santa Ana, California, United States
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Santa Monica, California, United States
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New Haven, Connecticut, United States
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Clearwater, Florida, United States
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Doral, Florida, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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North Miami Beach, Florida, United States
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Orange Park, Florida, United States
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Sweetwater, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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West Palm Beach, Florida, United States
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Albany, Georgia, United States
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Columbus, Georgia, United States
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Savannah, Georgia, United States
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Clarksville, Indiana, United States
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Indianapolis, Indiana, United States
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Plainfield, Indiana, United States
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Overland Park, Kansas, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Lake Charles, Louisiana, United States
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Bangor, Maine, United States
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Boston, Massachusetts, United States
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Brighton, Massachusetts, United States
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Quincy, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Troy, Michigan, United States
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West Bloomfield, Michigan, United States
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Ypsilanti, Michigan, United States
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Saint Joseph, Missouri, United States
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Missoula, Montana, United States
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Henderson, Nevada, United States
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East Windsor, New Jersey, United States
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Buffalo, New York, United States
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Cortland, New York, United States
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Horseheads, New York, United States
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Kew Gardens, New York, United States
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New York, New York, United States
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New York, New York, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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South Burlington, Vermont, United States
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Norfolk, Virginia, United States
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Morgantown, West Virginia, United States
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Brussels, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Herstal, , Belgium
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Liège, , Belgium
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Loverval, , Belgium
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Maldegem, , Belgium
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Calgary, Alberta, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Saskatoon, Saskatchewan, Canada
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Karlovy Vary, , Czechia
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Kutná Hora, , Czechia
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Ostrava-Poruba, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Marseille, Bouches-du-Rhône, France
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Dijon, , France
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Grenoble, , France
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Lille, , France
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Nice, , France
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Paris, , France
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Pierre-Bénite, , France
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Rouen, , France
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Saint-Etienne, , France
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Toulouse, , France
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Valence, , France
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Aachen, , Germany
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Erlangen, , Germany
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Frankfurt am Main, , Germany
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Friedrichshafen, , Germany
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Gera, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Jena, , Germany
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Münster, , Germany
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Osnabrück, , Germany
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Selters, , Germany
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Tübingen, , Germany
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Brescia, , Italy
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Catania, , Italy
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L’Aquila, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Ichikawa-shi, Chiba, Japan
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Ichikawa-shi, Chiba, Japan
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Chikushino-shi, Fukuoka, Japan
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Asahikawa, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Nonoichi-shi, Ishikawa-ken, Japan
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Kagoshima, Kagoshima-ken, Japan
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Kawasaki-shi, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Toyonaka-shi, Osaka, Japan
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Koto-Ku, Tokyo, Japan
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Minato-Ku, Tokyo, Japan
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Setagaya-ku, Tokyo, Japan
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Shinjuku-Ku, Tokyo, Japan
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Chūōku, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Fukushima, , Japan
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Gifu, , Japan
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Hamamatsu, , Japan
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Hyōgo, , Japan
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Hyōgo, , Japan
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Ichinomiya, , Japan
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Kagoshima, , Japan
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Kyoto, , Japan
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Morioka, , Japan
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Nagoya, , Japan
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Obihiro, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Shimotsuke-shi, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Toyama, , Japan
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Bialystok, , Poland
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Bochnia, , Poland
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Bydgoszcz, , Poland
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Gdynia, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Rzeszów, , Poland
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Rzeszów, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Alicante, , Spain
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Badalona, , Spain
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Barakaldo, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Fuenlabrada, , Spain
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Granada, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Pamplona, , Spain
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Pontevedra, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Birmingham, , United Kingdom
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Cambridge, , United Kingdom
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Cottingham, , United Kingdom
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Dudley, , United Kingdom
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Dundee, , United Kingdom
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Harlow, , United Kingdom
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Harrogate, , United Kingdom
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Leytonstone, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Redhill, , United Kingdom
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Salford, , United Kingdom
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Sheffield, , United Kingdom
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Southampton, , United Kingdom
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Wakefield, , United Kingdom
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Walsall, , United Kingdom
Countries
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References
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Blauvelt A, Langley RG, Lacour JP, Toth D, Laquer V, Beissert S, Wollenberg A, Herranz P, Pink AE, Peris K, Fangel S, Gjerum L, Corriveau J, Saeki H, Warren RB, Simpson E, Reich K. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022 Oct;87(4):815-824. doi: 10.1016/j.jaad.2022.07.019. Epub 2022 Jul 19.
Guttman-Yassky E, Kabashima K, Staumont-Salle D, Nahm WK, Pauser S, Da Rosa JC, Martel BC, Madsen DE, Ropke M, Arlert P, Steffensen L, Blauvelt A, Reich K. Targeting IL-13 with tralokinumab normalizes type 2 inflammation in atopic dermatitis both early and at 2 years. Allergy. 2024 Jun;79(6):1560-1572. doi: 10.1111/all.16108. Epub 2024 Apr 2.
Blauvelt A, Pink A, Worm M, Langley RGB, Elewski BE, Gjerum L, Guttman-Yassky E. Outcomes of COVID-19 and Vaccination in Patients With Moderate to Severe Atopic Dermatitis Treated With Tralokinumab. JAMA Dermatol. 2022 Nov 1;158(11):1327-1330. doi: 10.1001/jamadermatol.2022.3488.
Mayo T, Silverberg JI, Armstrong A, Guttman-Yassky E, Blauvelt A, Esdaile B, Kabashima K, Gooderham M, Kircik L, Schneider S, Bennike N, von Eyben R, Martel BC, Ropke MA, Katoh N, Alexis AF. Efficacy and Safety of Tralokinumab Across Racial Subgroups in Adults with Moderate-to-Severe Atopic Dermatitis: Post Hoc Analysis of Phase III Trials. Am J Clin Dermatol. 2025 Oct 21. doi: 10.1007/s40257-025-00985-1. Online ahead of print.
Reich K, Langley RG, Salvador JFS, Staumont-Salle D, Costanzo A, Pink AE, Paller AS, Katoh N, Wollenberg A, Warren RB, Blauvelt A, Oland CB, Tindberg AM, Gjerum L, Simpson EL. Safety of tralokinumab in patients with moderate-to-severe atopic dermatitis followed for up to 4.5 years: an integrated analysis of 8 clinical trials. Br J Dermatol. 2025 Aug 29:ljaf309. doi: 10.1093/bjd/ljaf309. Online ahead of print.
Chovatiya R, Ribero S, Wollenberg A, Park CO, Silvestre JF, Hong HC, Seneschal J, Saeki H, Thyssen JP, Oland CB, Gjerum L, Maslin D, Blauvelt A. Long-Term Disease Control and Minimal Disease Activity of Head and Neck Atopic Dermatitis in Patients Treated with Tralokinumab up to 4 Years. Am J Clin Dermatol. 2025 Jul;26(4):587-601. doi: 10.1007/s40257-025-00931-1. Epub 2025 Mar 14.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-000746-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1282-4519
Identifier Type: OTHER
Identifier Source: secondary_id
LP0162-1337
Identifier Type: -
Identifier Source: org_study_id
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