Clinical trial NCT03587805: Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
Official title: An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2018-07-16
Enrollment: 1672
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.


Eligibility criteria: Inclusion Criteria:

* Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, -1343, -1346, or TRA-WEI-0015-I.
* 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:

* Any condition that required permanent discontinuation of trial treatment in the parent trial.
* 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.

Primary outcomes:
measure: Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268)
timeFrame: From Week 0 up to Week 268
Secondary outcomes:
measure: Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
timeFrame: From Week 16 up to Week 248
measure: At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
timeFrame: From Week 16 up to Week 248
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: LEO Pharma Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: LEO Pharma Investigational Site
state: Alabama
city: Mobile
country: United States
facility: LEO Pharma Investigational Site
state: Alabama
city: Fort Smith
country: United States
facility: LEO Pharma Investigational Site
state: Arkansas
city: Bakersfield
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Beverly Hills
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Encinitas
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Fountain Valley
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Fremont
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Fullerton
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Los Angeles
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Los Angeles
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Los Angeles
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Newport Beach
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Northridge
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Palo Alto
country: United States
facility: LEO Pharma Investigational Site
state: California
city: San Diego
country: United States
facility: LEO Pharma Investigational Site
state: California
city: San Diego
country: United States
facility: LEO Pharma Investigational Site
state: California
city: San Francisco
country: United States
facility: LEO Pharma Investigational Site
state: California
city: San Luis Obispo
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Santa Ana
country: United States
facility: LEO Pharma Investigational Site
state: California
city: Santa Monica
country: United States
facility: LEO Pharma Investigational Site
state: California
city: New Haven
country: United States
facility: LEO Pharma Investigational Site
state: Connecticut
city: Clearwater
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: Doral
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: Hialeah
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: Miami
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: Miami
country: United States
facility: LEO Pharma Investigational Site 1
state: Florida
city: Miami
country: United States
facility: LEO Pharma Investigational Site 2
state: Florida
city: North Miami Beach
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: Orange Park
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: Sweetwater
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: Tampa
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: LEO Pharma Investigational Site
state: Florida
city: Albany
country: United States
facility: LEO Pharma Investigational Site
state: Georgia
city: Columbus
country: United States
facility: LEO Pharma Investigational Site
state: Georgia
city: Macon
country: United States
facility: LEO Pharma Investigational Site
state: Georgia
city: Newnan
country: United States
facility: LEO Pharma Investigational Site
state: Georgia
city: Savannah
country: United States
facility: LEO Pharma Investigational Site
state: Georgia
city: Chicago
country: United States
facility: LEO Pharma Investigational Site
state: Illinois
city: Clarksville
country: United States
facility: LEO Pharma Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: LEO Pharma Investigational Site
state: Indiana
city: Plainfield
country: United States
facility: LEO Pharma Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: LEO Pharma Investigational Site
state: Kansas
city: Louisville
country: United States
facility: LEO Pharma Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: LEO Pharma Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: LEO Pharma Investigational Site
state: Louisiana
city: Lake Charles
country: United States
facility: LEO Pharma Investigational Site
state: Louisiana
city: Bangor
country: United States
facility: LEO Pharma Investigational Site
state: Maine
city: Boston
country: United States
facility: LEO Pharma Investigational Site
state: Massachusetts
city: Brighton
country: United States
facility: LEO Pharma Investigational Site
state: Massachusetts
city: Quincy
country: United States
facility: LEO Pharma Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: LEO Pharma Investigational Site
state: Michigan
city: Detroit
country: United States
facility: LEO Pharma Investigational Site
state: Michigan
city: Troy
country: United States
facility: LEO Pharma Investigational Site
state: Michigan
city: West Bloomfield
country: United States
facility: LEO Pharma Investigational Site
state: Michigan
city: Ypsilanti
country: United States
facility: LEO Pharma Investigational Site
state: Michigan
city: Saint Joseph
country: United States
facility: LEO Pharma Investigational Site
state: Missouri
city: Missoula
country: United States
facility: LEO Pharma Investigational Site
state: Montana
city: Henderson
country: United States
facility: LEO Pharma Investigational Site
state: Nevada
city: East Windsor
country: United States
facility: LEO Pharma Investigational Site
state: New Jersey
city: Buffalo
country: United States
facility: LEO Pharma Investigational Site
state: New York
city: Cortland
country: United States
facility: LEO Pharma Investigational Site
state: New York
city: Horseheads
country: United States
facility: LEO Pharma Investigational Site
state: New York
city: Kew Gardens
country: United States
facility: LEO Pharma Investigational Site
state: New York
city: New York
country: United States
facility: LEO Pharma Investigational Site
state: New York
city: New York
country: United States
facility: LEO Pharma Investigational Site
state: New York
city: New York
country: United States
facility: LEO Pharma Investigational Site
state: New York
city: New York
country: United States
facility: LEO Pharma Investigational Site
state: New York
city: Raleigh
country: United States
facility: LEO Pharma Investigational Site
state: North Carolina
city: Bexley
country: United States
facility: LEO Pharma Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: LEO Pharma Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: LEO Pharma Investigational Site
state: Ohio
city: Dublin
country: United States
facility: LEO Pharma Investigational Site
state: Ohio
city: Fairborn
country: United States
facility: LEO Pharma Investigational Site
state: Ohio
city: Toledo
country: United States
facility: LEO Pharma Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: LEO Pharma Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: LEO Pharma Investigational Site
state: Oregon
city: Portland
country: United States
facility: LEO Pharma Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: LEO Pharma Investigational Site
state: Pennsylvania
city: North Charleston
country: United States
facility: LEO Pharma Investigational Site
state: South Carolina
city: Goodlettsville
country: United States
facility: LEO Pharma Investigational Site
state: Tennessee
city: Austin
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: Bellaire
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: Dallas
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: Frisco
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: Houston
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: Pflugerville
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: San Antonio
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: San Antonio
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: Webster
country: United States
facility: LEO Pharma Investigational Site
state: Texas
city: South Burlington
country: United States
facility: LEO Pharma Investigational Site
state: Vermont
city: Norfolk
country: United States
facility: LEO Pharma Investigational Site
state: Virginia
city: Morgantown
country: United States
facility: LEO Pharma Investigational Site
state: West Virginia
city: Brussels
country: Belgium
facility: LEO Pharma Investigational Site
city: Brussel
country: Belgium
facility: LEO Pharma Investigational Site
city: Edegem
country: Belgium
facility: LEO Pharma Investigational Site
city: Gent
country: Belgium
facility: LEO Pharma Investigational Site
city: Gent
country: Belgium
facility: LEO Pharma Investigational Site
city: Herstal
country: Belgium
facility: LEO Pharma Investigational Site
city: Kortrijk
country: Belgium
facility: LEO Pharma Investigational Site
city: Leuven
country: Belgium
facility: LEO Pharma Investigational Site
city: Liège
country: Belgium
facility: LEO Pharma Investigational Site
city: Loverval
country: Belgium
facility: LEO Pharma Investigational Site
city: Maldegem
country: Belgium
facility: LEO Pharma Investigational Site
city: Calgary
country: Canada
facility: LEO Pharma Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: LEO Pharma Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: LEO Pharma Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: LEO Pharma Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: LEO Pharma Investigational Site
state: Alberta
city: Surrey
country: Canada
facility: LEO Pharma Investigational Site
state: British Columbia
city: Surrey
country: Canada
facility: LEO Pharma Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: LEO Pharma Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: LEO Pharma Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: LEO Pharma Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: LEO Pharma Investigational Site
state: Manitoba
city: Bathurst
country: Canada
facility: LEO Pharma Investigational Site
state: New Brunswick
city: Fredericton
country: Canada
facility: LEO Pharma Investigational Site
state: New Brunswick
city: Saint John's
country: Canada
facility: LEO Pharma Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: LEO Pharma Investigational Site
state: Nova Scotia
city: Ajax
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Etobicoke
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: London
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: London
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Markham
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: North Bay
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Richmond Hill
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Richmond Hill
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Waterloo
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: LEO Pharma Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: LEO Pharma Investigational Site
state: Quebec
city: Québec
country: Canada
facility: LEO Pharma Investigational Site
state: Quebec
city: Verdun
country: Canada
facility: LEO Pharma Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: LEO Pharma Investigational Site
state: Saskatchewan
city: Karlovy Vary
country: Czechia
facility: LEO Pharma Investigational Site
city: Kutná Hora
country: Czechia
facility: LEO Pharma Investigational Site
city: Ostrava-Poruba
country: Czechia
facility: LEO Pharma Investigational Site
city: Pardubice
country: Czechia
facility: LEO Pharma Investigational Site
city: Prague
country: Czechia
facility: LEO Pharma Investigational Site
city: Prague
country: Czechia
facility: LEO Pharma Investigational Site
city: Marseille
country: France
facility: LEO Pharma Investigational Site
state: Bouches-du-Rhône
city: Bordeaux
country: France
facility: LEO Pharma Investigational Site
city: Dijon
country: France
facility: LEO Pharma Investigational Site
city: Grenoble
country: France
facility: LEO Pharma Investigational Site
city: Lille
country: France
facility: LEO Pharma Investigational Site
city: Martigues
country: France
facility: LEO Pharma Investigational Site
city: Mulhouse
country: France
facility: LEO Pharma Investigational Site
city: Nice
country: France
facility: LEO Pharma Investigational Site
city: Paris
country: France
facility: LEO Pharma Investigational Site
city: Pierre-Bénite
country: France
facility: LEO Pharma Investigational Site
city: Rouen
country: France
facility: LEO Pharma Investigational Site
city: Saint-Étienne
country: France
facility: LEO Pharma Investigational Site
city: Toulouse
country: France
facility: LEO Pharma Investigational Site
city: Valence
country: France
facility: LEO Pharma Investigational Site
city: Aachen
country: Germany
facility: LEO Pharma Investigational Site
city: Augsburg
country: Germany
facility: LEO Pharma Investigational Site
city: Bad Bentheim
country: Germany
facility: LEO Pharma Investigational Site
city: Berlin
country: Germany
facility: LEO Pharma Investigational Site
city: Berlin
country: Germany
facility: LEO Pharma Investigational Site
city: Berlin
country: Germany
facility: LEO Pharma Investigational Site
city: Bielefeld
country: Germany
facility: LEO Pharma Investigational Site
city: Bochum
country: Germany
facility: LEO Pharma Investigational Site
city: Bochum
country: Germany
facility: LEO Pharma Investigational Site
city: Bonn
country: Germany
facility: LEO Pharma Investigational Site
city: Darmstadt
country: Germany
facility: LEO Pharma Investigational Site
city: Dresden
country: Germany
facility: LEO Pharma Investigational Site
city: Dülmen
country: Germany
facility: LEO Pharma Investigational Site
city: Erlangen
country: Germany
facility: LEO Pharma Investigational Site
city: Frankfurt am Main
country: Germany
facility: LEO Pharma Investigational Site
city: Friedrichshafen
country: Germany
facility: LEO Pharma Investigational Site
city: Gera
country: Germany
facility: LEO Pharma Investigational Site
city: Halle
country: Germany
facility: LEO Pharma Investigational Site
city: Hamburg
country: Germany
facility: LEO Pharma Investigational Site
city: Hamburg
country: Germany
facility: LEO Pharma Investigational Site
city: Hanover
country: Germany
facility: LEO Pharma Investigational Site
city: Jena
country: Germany
facility: LEO Pharma Investigational Site
city: Kiel
country: Germany
facility: LEO Pharma Investigational Site
city: Leipzig
country: Germany
facility: LEO Pharma Investigational Site
city: Mainz
country: Germany
facility: LEO Pharma Investigational Site
city: München
country: Germany
facility: LEO Pharma Investigational Site
city: Münster
country: Germany
facility: LEO Pharma Investigational Site
city: Osnabrück
country: Germany
facility: LEO Pharma Investigational Site
city: Selters
country: Germany
facility: LEO Pharma Investigational Site
city: Tübingen
country: Germany
facility: LEO Pharma Investigational Site
city: Brescia
country: Italy
facility: LEO Pharma Investigational Site
city: Catania
country: Italy
facility: LEO Pharma Investigational Site
city: L'Aquila
country: Italy
facility: LEO Pharma Investigational Site
city: Roma
country: Italy
facility: LEO Pharma Investigational Site
city: Roma
country: Italy
facility: LEO Pharma Investigational Site
city: Rozzano
country: Italy
facility: LEO Pharma Investigational Site
city: Ichikawa-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Chiba
city: Ichikawa-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Chiba
city: Chikushino-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Fukuoka
city: Asahikawa
country: Japan
facility: LEO Pharma Investigational Site
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Hokkaido
city: Nonoichi-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Ishikawa
city: Kagoshima-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Kagoshima
city: Kawasaki-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Kanagawa
city: Toyonaka-shi
country: Japan
facility: LEO Pharma Investigational Site
state: Osaka
city: Koto-Ku
country: Japan
facility: LEO Pharma Investigational Site
state: Tokyo
city: Minato-Ku
country: Japan
facility: LEO Pharma Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: LEO Pharma Investigational Site
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: LEO Pharma Investigational Site
state: Tokyo
city: Chuo Ku
country: Japan
facility: LEO Pharma Investigational Site
city: Chuo Ku
country: Japan
facility: LEO Pharma Investigational Site
city: Fukuoka
country: Japan
facility: LEO Pharma Investigational Site
city: Fukushima
country: Japan
facility: LEO Pharma Investigational Site
city: Gifu
country: Japan
facility: LEO Pharma Investigational Site
city: Hamamatsu
country: Japan
facility: LEO Pharma Investigational Site
city: Hyōgo
country: Japan
facility: LEO Pharma Investigational Site
city: Hyōgo
country: Japan
facility: LEO Pharma Investigational Site
city: Ichinomiya
country: Japan
facility: LEO Pharma Investigational Site
city: Kagoshima
country: Japan
facility: LEO Pharma Investigational Site
city: Kyoto
country: Japan
facility: LEO Pharma Investigational Site
city: Morioka City
country: Japan
facility: LEO Pharma Investigational Site
city: Nagoya-shi
country: Japan
facility: LEO Pharma Investigational Site
city: Obihiro
country: Japan
facility: LEO Pharma Investigational Site
city: Osaka
country: Japan
facility: LEO Pharma Investigational Site 2
city: Osaka
country: Japan
facility: LEO Pharma Investigational Site 1
city: Osaka
country: Japan
facility: LEO Pharma Investigational Site
city: Osaka
country: Japan
facility: LEO Pharma Investigational Site
city: Shimotsuke-shi
country: Japan
facility: LEO Pharma Investigational Site
city: Tokyo
country: Japan
facility: LEO Pharma Investigational Site
city: Tokyo
country: Japan
facility: LEO Pharma Investigational Site
city: Tokyo
country: Japan
facility: LEO Pharma Investigational Site
city: Tokyo
country: Japan
facility: LEO Pharma Investigational Site
city: Toyama
country: Japan
facility: LEO Pharma Investigational Site
city: Białystok
country: Poland
facility: LEO Pharma Investigational Site
city: Bochnia
country: Poland
facility: LEO Pharma Investigational Site
city: Bydgoszcz
country: Poland
facility: LEO Pharma Investigational Site
city: Gdańsk
country: Poland
facility: LEO Pharma Investigational Site
city: Gdynia
country: Poland
facility: LEO Pharma Investigational Site
city: Gdynia
country: Poland
facility: LEO Pharma Investigational Site
city: Katowice
country: Poland
facility: LEO Pharma Investigational Site
city: Kraków
country: Poland
facility: LEO Pharma Investigational Site
city: Kraków
country: Poland
facility: LEO Pharma Investigational Site
city: Kraków
country: Poland
facility: LEO Pharma Investigational Site
city: Kraków
country: Poland
facility: LEO Pharma Investigational Site
city: Kraków
country: Poland
facility: LEO Pharma Investigational Site
city: Kraków
country: Poland
facility: LEO Pharma Investigational Site
city: Kraków
country: Poland
facility: LEO Pharma Investigational Site
city: Lublin
country: Poland
facility: LEO Pharma Investigational Site
city: Lublin
country: Poland
facility: LEO Pharma Investigational Site
city: Poznań
country: Poland
facility: LEO Pharma Investigational Site
city: Poznań
country: Poland
facility: LEO Pharma Investigational Site
city: Rzeszów
country: Poland
facility: LEO Pharma Investigational Site
city: Rzeszów
country: Poland
facility: LEO Pharma Investigational Site
city: Warszawa
country: Poland
facility: LEO Pharma Investigational Site
city: Warszawa
country: Poland
facility: LEO Pharma Investigational Site
city: Warszawa
country: Poland
facility: LEO Pharma Investigational Site
city: Warszawa
country: Poland
facility: LEO Pharma Investigational Site
city: Wrocław
country: Poland
facility: LEO Pharma Investigational Site
city: Wrocław
country: Poland
facility: LEO Pharma Investigational Site
city: Wrocław
country: Poland
facility: LEO Pharma Investigational Site
city: Łódź
country: Poland
facility: LEO Pharma Investigational Site
city: Łódź
country: Poland
facility: LEO Pharma Investigational Site
city: Łódź
country: Poland
facility: LEO Pharma Investigational Site
city: Łódź
country: Poland
facility: LEO Pharma Investigational Site
city: Alicante
country: Spain
facility: LEO Pharma Investigational Site
city: Badalona
country: Spain
facility: LEO Pharma Investigational Site
city: Barakaldo
country: Spain
facility: LEO Pharma Investigational Site
city: Barcelona
country: Spain
facility: LEO Pharma Investigational Site
city: Barcelona
country: Spain
facility: LEO Pharma Investigational Site
city: Barcelona
country: Spain
facility: LEO Pharma Investigational Site
city: Bilbao
country: Spain
facility: LEO Pharma Investigational Site
city: Cordoba
country: Spain
facility: LEO Pharma Investigational Site
city: Fuenlabrada
country: Spain
facility: LEO Pharma Investigational Site
city: Granada
country: Spain
facility: LEO Pharma Investigational Site
city: L'Hospitalet De Llobregat
country: Spain
facility: LEO Pharma Investigational Site
city: Madrid
country: Spain
facility: LEO Pharma Investigational Site
city: Madrid
country: Spain
facility: LEO Pharma Investigational Site
city: Madrid
country: Spain
facility: LEO Pharma Investigational Site
city: Madrid
country: Spain
facility: LEO Pharma Investigational Site
city: Pamplona
country: Spain
facility: LEO Pharma Investigational Site
city: Pontevedra
country: Spain
facility: LEO Pharma Investigational Site
city: Sevilla
country: Spain
facility: LEO Pharma Investigational Site
city: Valencia
country: Spain
facility: LEO Pharma Investigational Site
city: Valencia
country: Spain
facility: LEO Pharma Investigational Site
city: Birmingham
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Cambridge
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Cottingham
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Dudley
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Dundee
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Harlow
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Harrogate
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Leytonstone
country: United Kingdom
facility: LEO Pharma Investigational Site
city: London
country: United Kingdom
facility: LEO Pharma Investigational Site
city: London
country: United Kingdom
facility: LEO Pharma Investigational Site
city: London
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Redhill
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Salford
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Sheffield
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Southampton
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Wakefield
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Walsall
country: United Kingdom
facility: LEO Pharma Investigational Site
Study officials:
affiliation: LEO Pharma
name: Medical expert
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.