Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03587805
• Other study ID #: LP0162-1337
• Secondary ID: 2018-000746-19U1
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 18, 2018
• Est. completion date: June 13, 2025

Study information

• Verified date: March 2024
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1672
• Est. completion date: June 13, 2025
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	LEO Pharma Investigational Site	Brussel
Belgium	LEO Pharma Investigational Site	Brussels
Belgium	LEO Pharma Investigational Site	Edegem
Belgium	LEO Pharma Investigational Site	Gent
Belgium	LEO Pharma Investigational Site	Gent
Belgium	LEO Pharma Investigational Site	Herstal
Belgium	LEO Pharma Investigational Site	Kortrijk
Belgium	LEO Pharma Investigational Site	Leuven
Belgium	LEO Pharma Investigational Site	Liège
Belgium	LEO Pharma Investigational Site	Loverval
Belgium	LEO Pharma Investigational Site	Maldegem
Canada	LEO Pharma Investigational Site	Ajax	Ontario
Canada	LEO Pharma Investigational Site	Bathurst	New Brunswick
Canada	LEO Pharma Investigational Site	Calgary	Alberta
Canada	LEO Pharma Investigational Site	Calgary	Alberta
Canada	LEO Pharma Investigational Site	Edmonton	Alberta
Canada	LEO Pharma Investigational Site	Edmonton	Alberta
Canada	LEO Pharma Investigational Site	Edmonton	Alberta
Canada	LEO Pharma Investigational Site	Etobicoke	Ontario
Canada	LEO Pharma Investigational Site	Fredericton	New Brunswick
Canada	LEO Pharma Investigational Site	Halifax	Nova Scotia
Canada	LEO Pharma Investigational Site	Hamilton	Ontario
Canada	LEO Pharma Investigational Site	London	Ontario
Canada	LEO Pharma Investigational Site	London	Ontario
Canada	LEO Pharma Investigational Site	Markham	Ontario
Canada	LEO Pharma Investigational Site	Mississauga	Ontario
Canada	LEO Pharma Investigational Site	Montreal	Quebec
Canada	LEO Pharma Investigational Site	North Bay	Ontario
Canada	LEO Pharma Investigational Site	Oakville	Ontario
Canada	LEO Pharma Investigational Site	Ottawa	Ontario
Canada	LEO Pharma Investigational Site	Peterborough	Ontario
Canada	LEO Pharma Investigational Site	Québec	Quebec
Canada	LEO Pharma Investigational Site	Richmond Hill	Ontario
Canada	LEO Pharma Investigational Site	Richmond Hill	Ontario
Canada	LEO Pharma Investigational Site	Saint John's	Newfoundland and Labrador
Canada	LEO Pharma Investigational Site	Saskatoon	Saskatchewan
Canada	LEO Pharma Investigational Site	Surrey	British Columbia
Canada	LEO Pharma Investigational Site	Surrey	British Columbia
Canada	LEO Pharma Investigational Site	Toronto	Ontario
Canada	LEO Pharma Investigational Site	Toronto	Ontario
Canada	LEO Pharma Investigational Site	Toronto	Ontario
Canada	LEO Pharma Investigational Site	Vancouver	British Columbia
Canada	LEO Pharma Investigational Site	Vancouver	British Columbia
Canada	LEO Pharma Investigational Site	Verdun	Quebec
Canada	LEO Pharma Investigational Site	Waterloo	Ontario
Canada	LEO Pharma Investigational Site	Windsor	Ontario
Canada	LEO Pharma Investigational Site	Windsor	Ontario
Canada	LEO Pharma Investigational Site	Winnipeg	Manitoba
Canada	LEO Pharma Investigational Site	Winnipeg	Manitoba
Czechia	LEO Pharma Investigational Site	Karlovy Vary
Czechia	LEO Pharma Investigational Site	Kutná Hora
Czechia	LEO Pharma Investigational Site	Ostrava-Poruba
Czechia	LEO Pharma Investigational Site	Pardubice
Czechia	LEO Pharma Investigational Site	Prague
Czechia	LEO Pharma Investigational Site	Prague
France	LEO Pharma Investigational Site	Bordeaux
France	LEO Pharma Investigational Site	Dijon
France	LEO Pharma Investigational Site	Grenoble
France	LEO Pharma Investigational Site	Lille
France	LEO Pharma Investigational Site	Marseille	Bouches-du-Rhône
France	LEO Pharma Investigational Site	Martigues
France	LEO Pharma Investigational Site	Mulhouse
France	LEO Pharma Investigational Site	Nice
France	LEO Pharma Investigational Site	Paris
France	LEO Pharma Investigational Site	Pierre-Bénite
France	LEO Pharma Investigational Site	Rouen
France	LEO Pharma Investigational Site	Saint-Étienne
France	LEO Pharma Investigational Site	Toulouse
France	LEO Pharma Investigational Site	Valence
Germany	LEO Pharma Investigational Site	Aachen
Germany	LEO Pharma Investigational Site	Augsburg
Germany	LEO Pharma Investigational Site	Bad Bentheim
Germany	LEO Pharma Investigational Site	Berlin
Germany	LEO Pharma Investigational Site	Berlin
Germany	LEO Pharma Investigational Site	Berlin
Germany	LEO Pharma Investigational Site	Bielefeld
Germany	LEO Pharma Investigational Site	Bochum
Germany	LEO Pharma Investigational Site	Bochum
Germany	LEO Pharma Investigational Site	Bonn
Germany	LEO Pharma Investigational Site	Darmstadt
Germany	LEO Pharma Investigational Site	Dresden
Germany	LEO Pharma Investigational Site	Dülmen
Germany	LEO Pharma Investigational Site	Erlangen
Germany	LEO Pharma Investigational Site	Frankfurt am Main
Germany	LEO Pharma Investigational Site	Friedrichshafen
Germany	LEO Pharma Investigational Site	Gera
Germany	LEO Pharma Investigational Site	Halle
Germany	LEO Pharma Investigational Site	Hamburg
Germany	LEO Pharma Investigational Site	Hamburg
Germany	LEO Pharma Investigational Site	Hanover
Germany	LEO Pharma Investigational Site	Jena
Germany	LEO Pharma Investigational Site	Kiel
Germany	LEO Pharma Investigational Site	Leipzig
Germany	LEO Pharma Investigational Site	Mainz
Germany	LEO Pharma Investigational Site	München
Germany	LEO Pharma Investigational Site	Münster
Germany	LEO Pharma Investigational Site	Osnabrück
Germany	LEO Pharma Investigational Site	Selters
Germany	LEO Pharma Investigational Site	Tübingen
Italy	LEO Pharma Investigational Site	Brescia
Italy	LEO Pharma Investigational Site	Catania
Italy	LEO Pharma Investigational Site	L'Aquila
Italy	LEO Pharma Investigational Site	Roma
Italy	LEO Pharma Investigational Site	Roma
Italy	LEO Pharma Investigational Site	Rozzano
Japan	LEO Pharma Investigational Site	Asahikawa	Hokkaido
Japan	LEO Pharma Investigational Site	Chikushino-shi	Fukuoka
Japan	LEO Pharma Investigational Site	Chuo Ku
Japan	LEO Pharma Investigational Site	Chuo Ku
Japan	LEO Pharma Investigational Site	Fukuoka
Japan	LEO Pharma Investigational Site	Fukuoka-shi	Fukuoka
Japan	LEO Pharma Investigational Site	Fukushima
Japan	LEO Pharma Investigational Site	Gifu
Japan	LEO Pharma Investigational Site	Hamamatsu
Japan	LEO Pharma Investigational Site	Hyogo
Japan	LEO Pharma Investigational Site	Hyogo
Japan	LEO Pharma Investigational Site	Ichikawa-shi	Chiba
Japan	LEO Pharma Investigational Site	Ichikawa-shi	Chiba
Japan	LEO Pharma Investigational Site	Ichinomiya
Japan	LEO Pharma Investigational Site	Kagoshima
Japan	LEO Pharma Investigational Site	Kagoshima-shi	Kagoshima
Japan	LEO Pharma Investigational Site	Kawasaki-shi	Kanagawa
Japan	LEO Pharma Investigational Site	Koto-Ku	Tokyo
Japan	LEO Pharma Investigational Site	Kyoto
Japan	LEO Pharma Investigational Site	Minato-Ku	Tokyo
Japan	LEO Pharma Investigational Site	Morioka City
Japan	LEO Pharma Investigational Site	Nagoya-shi
Japan	LEO Pharma Investigational Site	Nonoichi-shi	Ishikawa
Japan	LEO Pharma Investigational Site	Obihiro
Japan	LEO Pharma Investigational Site	Osaka
Japan	LEO Pharma Investigational Site	Osaka
Japan	LEO Pharma Investigational Site 1	Osaka
Japan	LEO Pharma Investigational Site 2	Osaka
Japan	LEO Pharma Investigational Site	Sapporo-shi	Hokkaido
Japan	LEO Pharma Investigational Site	Sapporo-shi	Hokkaido
Japan	LEO Pharma Investigational Site	Setagaya-ku	Tokyo
Japan	LEO Pharma Investigational Site	Shimotsuke-shi
Japan	LEO Pharma Investigational Site	Shinjuku-Ku	Tokyo
Japan	LEO Pharma Investigational Site	Tokyo
Japan	LEO Pharma Investigational Site	Tokyo
Japan	LEO Pharma Investigational Site	Tokyo
Japan	LEO Pharma Investigational Site	Tokyo
Japan	LEO Pharma Investigational Site	Toyama
Japan	LEO Pharma Investigational Site	Toyonaka-shi	Osaka
Japan	LEO Pharma Investigational Site	Yokohama-shi	Kanagawa
Japan	LEO Pharma Investigational Site	Yokohama-shi	Kanagawa
Poland	LEO Pharma Investigational Site	Bialystok
Poland	LEO Pharma Investigational Site	Bochnia
Poland	LEO Pharma Investigational Site	Bydgoszcz
Poland	LEO Pharma Investigational Site	Gdansk
Poland	LEO Pharma Investigational Site	Gdynia
Poland	LEO Pharma Investigational Site	Gdynia
Poland	LEO Pharma Investigational Site	Katowice
Poland	LEO Pharma Investigational Site	Kraków
Poland	LEO Pharma Investigational Site	Kraków
Poland	LEO Pharma Investigational Site	Kraków
Poland	LEO Pharma Investigational Site	Kraków
Poland	LEO Pharma Investigational Site	Kraków
Poland	LEO Pharma Investigational Site	Kraków
Poland	LEO Pharma Investigational Site	Kraków
Poland	LEO Pharma Investigational Site	Lódz
Poland	LEO Pharma Investigational Site	Lódz
Poland	LEO Pharma Investigational Site	Lódz
Poland	LEO Pharma Investigational Site	Lódz
Poland	LEO Pharma Investigational Site	Lublin
Poland	LEO Pharma Investigational Site	Lublin
Poland	LEO Pharma Investigational Site	Poznan
Poland	LEO Pharma Investigational Site	Poznan
Poland	LEO Pharma Investigational Site	Rzeszów
Poland	LEO Pharma Investigational Site	Rzeszów
Poland	LEO Pharma Investigational Site	Warszawa
Poland	LEO Pharma Investigational Site	Warszawa
Poland	LEO Pharma Investigational Site	Warszawa
Poland	LEO Pharma Investigational Site	Warszawa
Poland	LEO Pharma Investigational Site	Wroclaw
Poland	LEO Pharma Investigational Site	Wroclaw
Poland	LEO Pharma Investigational Site	Wroclaw
Spain	LEO Pharma Investigational Site	Alicante
Spain	LEO Pharma Investigational Site	Badalona
Spain	LEO Pharma Investigational Site	Barakaldo
Spain	LEO Pharma Investigational Site	Barcelona
Spain	LEO Pharma Investigational Site	Barcelona
Spain	LEO Pharma Investigational Site	Barcelona
Spain	LEO Pharma Investigational Site	Bilbao
Spain	LEO Pharma Investigational Site	Cordoba
Spain	LEO Pharma Investigational Site	Fuenlabrada
Spain	LEO Pharma Investigational Site	Granada
Spain	LEO Pharma Investigational Site	L'Hospitalet De Llobregat
Spain	LEO Pharma Investigational Site	Madrid
Spain	LEO Pharma Investigational Site	Madrid
Spain	LEO Pharma Investigational Site	Madrid
Spain	LEO Pharma Investigational Site	Madrid
Spain	LEO Pharma Investigational Site	Pamplona
Spain	LEO Pharma Investigational Site	Pontevedra
Spain	LEO Pharma Investigational Site	Sevilla
Spain	LEO Pharma Investigational Site	Valencia
Spain	LEO Pharma Investigational Site	Valencia
United Kingdom	LEO Pharma Investigational Site	Birmingham
United Kingdom	LEO Pharma Investigational Site	Cambridge
United Kingdom	LEO Pharma Investigational Site	Cottingham
United Kingdom	LEO Pharma Investigational Site	Dudley
United Kingdom	LEO Pharma Investigational Site	Dundee
United Kingdom	LEO Pharma Investigational Site	Harlow
United Kingdom	LEO Pharma Investigational Site	Harrogate
United Kingdom	LEO Pharma Investigational Site	Leytonstone
United Kingdom	LEO Pharma Investigational Site	London
United Kingdom	LEO Pharma Investigational Site	London
United Kingdom	LEO Pharma Investigational Site	London
United Kingdom	LEO Pharma Investigational Site	Redhill
United Kingdom	LEO Pharma Investigational Site	Salford
United Kingdom	LEO Pharma Investigational Site	Sheffield
United Kingdom	LEO Pharma Investigational Site	Southampton
United Kingdom	LEO Pharma Investigational Site	Wakefield
United Kingdom	LEO Pharma Investigational Site	Walsall
United States	LEO Pharma Investigational Site	Albany	Georgia
United States	LEO Pharma Investigational Site	Ann Arbor	Michigan
United States	LEO Pharma Investigational Site	Austin	Texas
United States	LEO Pharma Investigational Site	Bakersfield	California
United States	LEO Pharma Investigational Site	Bangor	Maine
United States	LEO Pharma Investigational Site	Baton Rouge	Louisiana
United States	LEO Pharma Investigational Site	Bellaire	Texas
United States	LEO Pharma Investigational Site	Beverly Hills	California
United States	LEO Pharma Investigational Site	Bexley	Ohio
United States	LEO Pharma Investigational Site	Birmingham	Alabama
United States	LEO Pharma Investigational Site	Birmingham	Alabama
United States	LEO Pharma Investigational Site	Boston	Massachusetts
United States	LEO Pharma Investigational Site	Brighton	Massachusetts
United States	LEO Pharma Investigational Site	Buffalo	New York
United States	LEO Pharma Investigational Site	Chicago	Illinois
United States	LEO Pharma Investigational Site	Cincinnati	Ohio
United States	LEO Pharma Investigational Site	Cincinnati	Ohio
United States	LEO Pharma Investigational Site	Clarksville	Indiana
United States	LEO Pharma Investigational Site	Clearwater	Florida
United States	LEO Pharma Investigational Site	Columbus	Georgia
United States	LEO Pharma Investigational Site	Cortland	New York
United States	LEO Pharma Investigational Site	Dallas	Texas
United States	LEO Pharma Investigational Site	Detroit	Michigan
United States	LEO Pharma Investigational Site	Doral	Florida
United States	LEO Pharma Investigational Site	Dublin	Ohio
United States	LEO Pharma Investigational Site	East Windsor	New Jersey
United States	LEO Pharma Investigational Site	Encinitas	California
United States	LEO Pharma Investigational Site	Fairborn	Ohio
United States	LEO Pharma Investigational Site	Fort Smith	Arkansas
United States	LEO Pharma Investigational Site	Fountain Valley	California
United States	LEO Pharma Investigational Site	Fremont	California
United States	LEO Pharma Investigational Site	Frisco	Texas
United States	LEO Pharma Investigational Site	Fullerton	California
United States	LEO Pharma Investigational Site	Goodlettsville	Tennessee
United States	LEO Pharma Investigational Site	Henderson	Nevada
United States	LEO Pharma Investigational Site	Hialeah	Florida
United States	LEO Pharma Investigational Site	Horseheads	New York
United States	LEO Pharma Investigational Site	Houston	Texas
United States	LEO Pharma Investigational Site	Indianapolis	Indiana
United States	LEO Pharma Investigational Site	Kew Gardens	New York
United States	LEO Pharma Investigational Site	Lake Charles	Louisiana
United States	LEO Pharma Investigational Site	Los Angeles	California
United States	LEO Pharma Investigational Site	Los Angeles	California
United States	LEO Pharma Investigational Site	Los Angeles	California
United States	LEO Pharma Investigational Site	Louisville	Kentucky
United States	LEO Pharma Investigational Site	Louisville	Kentucky
United States	LEO Pharma Investigational Site	Macon	Georgia
United States	LEO Pharma Investigational Site	Miami	Florida
United States	LEO Pharma Investigational Site 1	Miami	Florida
United States	LEO Pharma Investigational Site 2	Miami	Florida
United States	LEO Pharma Investigational Site	Missoula	Montana
United States	LEO Pharma Investigational Site	Mobile	Alabama
United States	LEO Pharma Investigational Site	Morgantown	West Virginia
United States	LEO Pharma Investigational Site	New Haven	Connecticut
United States	LEO Pharma Investigational Site	New York	New York
United States	LEO Pharma Investigational Site	New York	New York
United States	LEO Pharma Investigational Site	New York	New York
United States	LEO Pharma Investigational Site	New York	New York
United States	LEO Pharma Investigational Site	Newnan	Georgia
United States	LEO Pharma Investigational Site	Newport Beach	California
United States	LEO Pharma Investigational Site	Norfolk	Virginia
United States	LEO Pharma Investigational Site	North Charleston	South Carolina
United States	LEO Pharma Investigational Site	North Miami Beach	Florida
United States	LEO Pharma Investigational Site	Northridge	California
United States	LEO Pharma Investigational Site	Orange Park	Florida
United States	LEO Pharma Investigational Site	Overland Park	Kansas
United States	LEO Pharma Investigational Site	Palo Alto	California
United States	LEO Pharma Investigational Site	Pflugerville	Texas
United States	LEO Pharma Investigational Site	Pittsburgh	Pennsylvania
United States	LEO Pharma Investigational Site	Plainfield	Indiana
United States	LEO Pharma Investigational Site	Portland	Oregon
United States	LEO Pharma Investigational Site	Portland	Oregon
United States	LEO Pharma Investigational Site	Quincy	Massachusetts
United States	LEO Pharma Investigational Site	Raleigh	North Carolina
United States	LEO Pharma Investigational Site	Saint Joseph	Missouri
United States	LEO Pharma Investigational Site	San Antonio	Texas
United States	LEO Pharma Investigational Site	San Antonio	Texas
United States	LEO Pharma Investigational Site	San Diego	California
United States	LEO Pharma Investigational Site	San Diego	California
United States	LEO Pharma Investigational Site	San Francisco	California
United States	LEO Pharma Investigational Site	San Luis Obispo	California
United States	LEO Pharma Investigational Site	Santa Ana	California
United States	LEO Pharma Investigational Site	Santa Monica	California
United States	LEO Pharma Investigational Site	Savannah	Georgia
United States	LEO Pharma Investigational Site	South Burlington	Vermont
United States	LEO Pharma Investigational Site	Sweetwater	Florida
United States	LEO Pharma Investigational Site	Tampa	Florida
United States	LEO Pharma Investigational Site	Toledo	Ohio
United States	LEO Pharma Investigational Site	Troy	Michigan
United States	LEO Pharma Investigational Site	Tulsa	Oklahoma
United States	LEO Pharma Investigational Site	Webster	Texas
United States	LEO Pharma Investigational Site	West Bloomfield	Michigan
United States	LEO Pharma Investigational Site	West Palm Beach	Florida
United States	LEO Pharma Investigational Site	West Palm Beach	Florida
United States	LEO Pharma Investigational Site	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  France,  Germany,  Italy,  Japan,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events from baseline through the last treatment visit (up to Week 268)		From Week 0 up to Week 268
Secondary	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	The IGA is an instrument used in clinical trials to rate the severity of the subject's global atopic dermatitis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).	From Week 16 up to Week 248
Secondary	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	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition.	From Week 16 up to Week 248