Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
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
3 other identifiers
interventional
1,672
11 countries
309
Brief Summary
The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2018
Longer than P75 for phase_3
309 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2018
CompletedFirst Submitted
Initial submission to the registry
July 3, 2018
CompletedFirst Posted
Study publicly available on registry
July 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2024
CompletedResults Posted
Study results publicly available
January 16, 2025
CompletedMarch 11, 2025
December 1, 2024
6.3 years
July 3, 2018
December 20, 2024
February 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268)
From Week 0 up to Week 268
Secondary Outcomes (2)
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
From Week 16 up to Week 248
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
From Week 16 up to Week 248
Study Arms (1)
Tralokinumab, all subjects
EXPERIMENTALWeek 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.
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (309)
LEO Pharma Investigational Site
Birmingham, Alabama, 35209, United States
LEO Pharma Investigational Site
Birmingham, Alabama, 35233, United States
LEO Pharma Investigational Site
Mobile, Alabama, 36695, United States
LEO Pharma Investigational Site
Fort Smith, Arkansas, 72916, United States
LEO Pharma Investigational Site
Bakersfield, California, 93301, United States
LEO Pharma Investigational Site
Beverly Hills, California, 90212, United States
LEO Pharma Investigational Site
Encinitas, California, 92024, United States
LEO Pharma Investigational Site
Fountain Valley, California, 92708, United States
LEO Pharma Investigational Site
Fremont, California, 94538, United States
LEO Pharma Investigational Site
Fullerton, California, 92835, United States
LEO Pharma Investigational Site
Los Angeles, California, 90025, United States
LEO Pharma Investigational Site
Los Angeles, California, 90033, United States
LEO Pharma Investigational Site
Los Angeles, California, 90045, United States
LEO Pharma Investigational Site
Newport Beach, California, 92660, United States
LEO Pharma Investigational Site
Northridge, California, 91324, United States
LEO Pharma Investigational Site
Palo Alto, California, 94304, United States
LEO Pharma Investigational Site
San Diego, California, 92119, United States
LEO Pharma Investigational Site
San Diego, California, 92123, United States
LEO Pharma Investigational Site
San Francisco, California, 94132, United States
LEO Pharma Investigational Site
San Luis Obispo, California, 93405, United States
LEO Pharma Investigational Site
Santa Ana, California, 92701, United States
LEO Pharma Investigational Site
Santa Monica, California, 90404, United States
LEO Pharma Investigational Site
New Haven, Connecticut, 06519, United States
LEO Pharma Investigational Site
Clearwater, Florida, 33756, United States
LEO Pharma Investigational Site
Doral, Florida, 33122, United States
LEO Pharma Investigational Site
Hialeah, Florida, 33012, United States
LEO Pharma Investigational Site
Miami, Florida, 33015, United States
LEO Pharma Investigational Site 1
Miami, Florida, 33144, United States
LEO Pharma Investigational Site 2
Miami, Florida, 33144, United States
LEO Pharma Investigational Site
North Miami Beach, Florida, 33162, United States
LEO Pharma Investigational Site
Orange Park, Florida, 32073, United States
LEO Pharma Investigational Site
Sweetwater, Florida, 33172, United States
LEO Pharma Investigational Site
Tampa, Florida, 33614, United States
LEO Pharma Investigational Site
West Palm Beach, Florida, 33401, United States
LEO Pharma Investigational Site
West Palm Beach, Florida, 33406, United States
LEO Pharma Investigational Site
Albany, Georgia, 31707, United States
LEO Pharma Investigational Site
Columbus, Georgia, 31904, United States
LEO Pharma Investigational Site
Macon, Georgia, 31217, United States
LEO Pharma Investigational Site
Newnan, Georgia, 30263, United States
LEO Pharma Investigational Site
Savannah, Georgia, 31406, United States
LEO Pharma Investigational Site
Chicago, Illinois, 60611, United States
LEO Pharma Investigational Site
Clarksville, Indiana, 47129, United States
LEO Pharma Investigational Site
Indianapolis, Indiana, 46250, United States
LEO Pharma Investigational Site
Plainfield, Indiana, 46168, United States
LEO Pharma Investigational Site
Overland Park, Kansas, 66215, United States
LEO Pharma Investigational Site
Louisville, Kentucky, 40215, United States
LEO Pharma Investigational Site
Louisville, Kentucky, 40217, United States
LEO Pharma Investigational Site
Baton Rouge, Louisiana, 70808, United States
LEO Pharma Investigational Site
Lake Charles, Louisiana, 70601, United States
LEO Pharma Investigational Site
Bangor, Maine, 04401, United States
LEO Pharma Investigational Site
Boston, Massachusetts, 02115, United States
LEO Pharma Investigational Site
Brighton, Massachusetts, 02135, United States
LEO Pharma Investigational Site
Quincy, Massachusetts, 02169, United States
LEO Pharma Investigational Site
Ann Arbor, Michigan, 48103, United States
LEO Pharma Investigational Site
Detroit, Michigan, 48202, United States
LEO Pharma Investigational Site
Troy, Michigan, 48084, United States
LEO Pharma Investigational Site
West Bloomfield, Michigan, 48322, United States
LEO Pharma Investigational Site
Ypsilanti, Michigan, 48197, United States
LEO Pharma Investigational Site
Saint Joseph, Missouri, 64506, United States
LEO Pharma Investigational Site
Missoula, Montana, 59808, United States
LEO Pharma Investigational Site
Henderson, Nevada, 89074, United States
LEO Pharma Investigational Site
East Windsor, New Jersey, 08520, United States
LEO Pharma Investigational Site
Buffalo, New York, 14203, United States
LEO Pharma Investigational Site
Cortland, New York, 13045, United States
LEO Pharma Investigational Site
Horseheads, New York, 14845, United States
LEO Pharma Investigational Site
Kew Gardens, New York, 11415, United States
LEO Pharma Investigational Site
New York, New York, 10021, United States
LEO Pharma Investigational Site
New York, New York, 10022, United States
LEO Pharma Investigational Site
New York, New York, 10028, United States
LEO Pharma Investigational Site
New York, New York, 10075, United States
LEO Pharma Investigational Site
Raleigh, North Carolina, 27612, United States
LEO Pharma Investigational Site
Bexley, Ohio, 43209, United States
LEO Pharma Investigational Site
Cincinnati, Ohio, 45219, United States
LEO Pharma Investigational Site
Cincinnati, Ohio, 45231, United States
LEO Pharma Investigational Site
Dublin, Ohio, 43016, United States
LEO Pharma Investigational Site
Fairborn, Ohio, 45324, United States
LEO Pharma Investigational Site
Toledo, Ohio, 43617, United States
LEO Pharma Investigational Site
Tulsa, Oklahoma, 74136, United States
LEO Pharma Investigational Site
Portland, Oregon, 97210, United States
LEO Pharma Investigational Site
Portland, Oregon, 97223, United States
LEO Pharma Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
LEO Pharma Investigational Site
North Charleston, South Carolina, 29420, United States
LEO Pharma Investigational Site
Goodlettsville, Tennessee, 37072, United States
LEO Pharma Investigational Site
Austin, Texas, 78759, United States
LEO Pharma Investigational Site
Bellaire, Texas, 77401, United States
LEO Pharma Investigational Site
Dallas, Texas, 75225, United States
LEO Pharma Investigational Site
Frisco, Texas, 75034, United States
LEO Pharma Investigational Site
Houston, Texas, 77004, United States
LEO Pharma Investigational Site
Pflugerville, Texas, 78660, United States
LEO Pharma Investigational Site
San Antonio, Texas, 78213, United States
LEO Pharma Investigational Site
San Antonio, Texas, 78218, United States
LEO Pharma Investigational Site
Webster, Texas, 77598, United States
LEO Pharma Investigational Site
South Burlington, Vermont, 05403, United States
LEO Pharma Investigational Site
Norfolk, Virginia, 23502, United States
LEO Pharma Investigational Site
Morgantown, West Virginia, 26505, United States
LEO Pharma Investigational Site
Brussels, 1090, Belgium
LEO Pharma Investigational Site
Brussels, 1200, Belgium
LEO Pharma Investigational Site
Edegem, 2650, Belgium
LEO Pharma Investigational Site
Ghent, 9000, Belgium
LEO Pharma Investigational Site
Ghent, B-9000, Belgium
LEO Pharma Investigational Site
Herstal, B-4040, Belgium
LEO Pharma Investigational Site
Kortrijk, 8500, Belgium
LEO Pharma Investigational Site
Leuven, 3000, Belgium
LEO Pharma Investigational Site
Liège, 4000 LIEGE, Belgium
LEO Pharma Investigational Site
Loverval, 6280, Belgium
LEO Pharma Investigational Site
Maldegem, 9990, Belgium
LEO Pharma Investigational Site
Calgary, Alberta, T2J 7E1, Canada
LEO Pharma Investigational Site
Calgary, Alberta, T3E 0B2, Canada
LEO Pharma Investigational Site
Edmonton, Alberta, T5K 1X3, Canada
LEO Pharma Investigational Site
Edmonton, Alberta, T6G 1C3, Canada
LEO Pharma Investigational Site
Edmonton, Alberta, T6G 2B7, Canada
LEO Pharma Investigational Site
Surrey, British Columbia, V3R 6A7, Canada
LEO Pharma Investigational Site
Surrey, British Columbia, V3V 0C6, Canada
LEO Pharma Investigational Site
Vancouver, British Columbia, V5Z 4E8, Canada
LEO Pharma Investigational Site
Vancouver, British Columbia, V6H 4E1, Canada
LEO Pharma Investigational Site
Winnipeg, Manitoba, R3C 0N2, Canada
LEO Pharma Investigational Site
Winnipeg, Manitoba, R3M 3Z4, Canada
LEO Pharma Investigational Site
Bathurst, New Brunswick, E2A 4Z9, Canada
LEO Pharma Investigational Site
Fredericton, New Brunswick, E3B 1G9, Canada
LEO Pharma Investigational Site
St. John's, Newfoundland and Labrador, A1A 4Y3, Canada
LEO Pharma Investigational Site
Halifax, Nova Scotia, B3H 1Z2, Canada
LEO Pharma Investigational Site
Ajax, Ontario, L1S 7K8, Canada
LEO Pharma Investigational Site
Etobicoke, Ontario, M8X 1Y9, Canada
LEO Pharma Investigational Site
Hamilton, Ontario, L8S 1G5, Canada
LEO Pharma Investigational Site
London, Ontario, N6A 3H7, Canada
LEO Pharma Investigational Site
London, Ontario, N6H 5L5, Canada
LEO Pharma Investigational Site
Markham, Ontario, L3P 1X3, Canada
LEO Pharma Investigational Site
Mississauga, Ontario, L5H 1G9, Canada
LEO Pharma Investigational Site
North Bay, Ontario, P1B 3Z7, Canada
LEO Pharma Investigational Site
Oakville, Ontario, L6J 7W5, Canada
LEO Pharma Investigational Site
Ottawa, Ontario, K2C 3N2, Canada
LEO Pharma Investigational Site
Peterborough, Ontario, K9J 5K2, Canada
LEO Pharma Investigational Site
Richmond Hill, Ontario, L4B 1A5, Canada
LEO Pharma Investigational Site
Richmond Hill, Ontario, L4C 9M7, Canada
LEO Pharma Investigational Site
Toronto, Ontario, M3B 3S6, Canada
LEO Pharma Investigational Site
Toronto, Ontario, M4W 2N2, Canada
LEO Pharma Investigational Site
Toronto, Ontario, M5A 3R6, Canada
LEO Pharma Investigational Site
Waterloo, Ontario, N2J 1C4, Canada
LEO Pharma Investigational Site
Windsor, Ontario, N8W 1E6, Canada
LEO Pharma Investigational Site
Windsor, Ontario, N8X 2G1, Canada
LEO Pharma Investigational Site
Montreal, Quebec, H3H 1V4, Canada
LEO Pharma Investigational Site
Québec, Quebec, G1V 4X7, Canada
LEO Pharma Investigational Site
Verdun, Quebec, H4G 3E7, Canada
LEO Pharma Investigational Site
Saskatoon, Saskatchewan, S7K 0H6, Canada
LEO Pharma Investigational Site
Karlovy Vary, 360 01, Czechia
LEO Pharma Investigational Site
Kutná Hora, 284 01, Czechia
LEO Pharma Investigational Site
Ostrava-Poruba, 708 52, Czechia
LEO Pharma Investigational Site
Pardubice, 530 02, Czechia
LEO Pharma Investigational Site
Prague, 100 00, Czechia
LEO Pharma Investigational Site
Prague, 110 00, Czechia
LEO Pharma Investigational Site
Marseille, Bouches-du-Rhône, 13285, France
LEO Pharma Investigational Site
Bordeaux, 33 075, France
LEO Pharma Investigational Site
Dijon, 21079, France
LEO Pharma Investigational Site
Grenoble, 38000, France
LEO Pharma Investigational Site
Lille, 59000, France
LEO Pharma Investigational Site
Martigues, 13500, France
LEO Pharma Investigational Site
Mulhouse, 68100, France
LEO Pharma Investigational Site
Nice, 06202, France
LEO Pharma Investigational Site
Paris, 75010, France
LEO Pharma Investigational Site
Pierre-Bénite, 69495, France
LEO Pharma Investigational Site
Rouen, 76031, France
LEO Pharma Investigational Site
Saint-Etienne, 42000, France
LEO Pharma Investigational Site
Toulouse, 31000, France
LEO Pharma Investigational Site
Valence, 26000, France
LEO Pharma Investigational Site
Aachen, 52074, Germany
LEO Pharma Investigational Site
Augsburg, 86179, Germany
LEO Pharma Investigational Site
Bad Bentheim, 48455, Germany
LEO Pharma Investigational Site
Berlin, 10115, Germany
LEO Pharma Investigational Site
Berlin, 10789, Germany
LEO Pharma Investigational Site
Berlin, 12203, Germany
LEO Pharma Investigational Site
Bielefeld, 33647, Germany
LEO Pharma Investigational Site
Bochum, 44791, Germany
LEO Pharma Investigational Site
Bochum, 44793, Germany
LEO Pharma Investigational Site
Bonn, 53127, Germany
LEO Pharma Investigational Site
Darmstadt, 64283, Germany
LEO Pharma Investigational Site
Dresden, 01307, Germany
LEO Pharma Investigational Site
Dülmen, 48249, Germany
LEO Pharma Investigational Site
Erlangen, 91054, Germany
LEO Pharma Investigational Site
Frankfurt am Main, 60590, Germany
LEO Pharma Investigational Site
Friedrichshafen, 88045, Germany
LEO Pharma Investigational Site
Gera, 07548, Germany
LEO Pharma Investigational Site
Halle, 06097, Germany
LEO Pharma Investigational Site
Hamburg, 20537, Germany
LEO Pharma Investigational Site
Hamburg, 22391, Germany
LEO Pharma Investigational Site
Hanover, 30159, Germany
LEO Pharma Investigational Site
Jena, 07743, Germany
LEO Pharma Investigational Site
Kiel, 24105, Germany
LEO Pharma Investigational Site
Leipzig, 04103, Germany
LEO Pharma Investigational Site
Mainz, 55128, Germany
LEO Pharma Investigational Site
München, 80337, Germany
LEO Pharma Investigational Site
Münster, 48149, Germany
LEO Pharma Investigational Site
Osnabrück, 49074, Germany
LEO Pharma Investigational Site
Selters, 56242, Germany
LEO Pharma Investigational Site
Tübingen, 72076, Germany
LEO Pharma Investigational Site
Brescia, 25123, Italy
LEO Pharma Investigational Site
Catania, 95123, Italy
LEO Pharma Investigational Site
L’Aquila, 67100, Italy
LEO Pharma Investigational Site
Roma, 00144, Italy
LEO Pharma Investigational Site
Roma, 00168, Italy
LEO Pharma Investigational Site
Rozzano, 20089, Italy
LEO Pharma Investigational Site
Ichikawa-shi, Chiba, 272-0033, Japan
LEO Pharma Investigational Site
Ichikawa-shi, Chiba, 272-0143, Japan
LEO Pharma Investigational Site
Chikushino-shi, Fukuoka, 818-0083, Japan
LEO Pharma Investigational Site
Fukuoka, Fukuoka, 814-0171, Japan
LEO Pharma Investigational Site
Asahikawa, Hokkaido, 070-8610, Japan
LEO Pharma Investigational Site
Sapporo, Hokkaido, 060-0807, Japan
LEO Pharma Investigational Site
Sapporo, Hokkaido, 063-0812, Japan
LEO Pharma Investigational Site
Nonoichi-shi, Ishikawa-ken, 921-8801, Japan
LEO Pharma Investigational Site
Kagoshima, Kagoshima-ken, 890-0063, Japan
LEO Pharma Investigational Site
Kawasaki-shi, Kanagawa, 211-0063, Japan
LEO Pharma Investigational Site
Yokohama, Kanagawa, 220-6208, Japan
LEO Pharma Investigational Site
Yokohama, Kanagawa, 221-0825, Japan
LEO Pharma Investigational Site
Toyonaka-shi, Osaka, 560-0085, Japan
LEO Pharma Investigational Site
Koto-Ku, Tokyo, 136-0074, Japan
LEO Pharma Investigational Site
Minato-Ku, Tokyo, 108-0014, Japan
LEO Pharma Investigational Site
Setagaya-ku, Tokyo, 158-0097, Japan
LEO Pharma Investigational Site
Shinjuku-Ku, Tokyo, 169-0075, Japan
LEO Pharma Investigational Site
Chūōku, 060-0033, Japan
LEO Pharma Investigational Site
Chūōku, 060-0063, Japan
LEO Pharma Investigational Site
Fukuoka, 814-0180, Japan
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Fukushima, 960-1295, Japan
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Gifu, 501-1194, Japan
LEO Pharma Investigational Site
Hamamatsu, 431-3192, Japan
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Hyōgo, 663-8186, Japan
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Hyōgo, 663-8501, Japan
LEO Pharma Investigational Site
Ichinomiya, 491-8558, Japan
LEO Pharma Investigational Site
Kagoshima, 890-8520, Japan
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Kyoto, 602-8566, Japan
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Morioka, 020-0066, Japan
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Nagoya, 457-8510, Japan
LEO Pharma Investigational Site
Obihiro, 080-0013, Japan
LEO Pharma Investigational Site 2
Osaka, 532-0003, Japan
LEO Pharma Investigational Site 1
Osaka, 553-0003, Japan
LEO Pharma Investigational Site
Osaka, 583-8588, Japan
LEO Pharma Investigational Site
Osaka, 593-8324, Japan
LEO Pharma Investigational Site
Shimotsuke-shi, 329-0498, Japan
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Tokyo, 105-8471, Japan
LEO Pharma Investigational Site
Tokyo, 113-8603, Japan
LEO Pharma Investigational Site
Tokyo, 160-0023, Japan
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Tokyo, 167-0035, Japan
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Toyama, 933-0871, Japan
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Bialystok, 15-375, Poland
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Bochnia, 32-700, Poland
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Bydgoszcz, 85-094, Poland
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Gdansk, 80-546, Poland
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Gdynia, 81-338, Poland
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Gdynia, 81-537, Poland
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Katowice, 40-040, Poland
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Krakow, 30-033, Poland
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Krakow, 30-149, Poland
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Krakow, 30-510, Poland
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Krakow, 31-011, Poland
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Krakow, 31-147, Poland
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Krakow, 31-501, Poland
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Krakow, 31-559, Poland
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Lodz, 90-242, Poland
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Lodz, 90-265, Poland
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Lodz, 90-436, Poland
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Lodz, 90-752, Poland
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Lublin, 20-081, Poland
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Lublin, 20-406, Poland
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Poznan, 60-369, Poland
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Poznan, 60-702, Poland
LEO Pharma Investigational Site
Rzeszów, 35-055, Poland
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Rzeszów, 35-612, Poland
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Warsaw, 01-141, Poland
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Warsaw, 01-817, Poland
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Warsaw, 02-625, Poland
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Warsaw, 02-953, Poland
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Wroclaw, 51-318, Poland
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Wroclaw, 51-685, Poland
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Wroclaw, 52-416, Poland
LEO Pharma Investigational Site
Alicante, 03010, Spain
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Badalona, 08915, Spain
LEO Pharma Investigational Site
Barakaldo, 48903, Spain
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Barcelona, 08003, Spain
LEO Pharma Investigational Site
Barcelona, 08036, Spain
LEO Pharma Investigational Site
Barcelona, 08041, Spain
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Bilbao, 48013, Spain
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Córdoba, 14004, Spain
LEO Pharma Investigational Site
Fuenlabrada, 28942, Spain
LEO Pharma Investigational Site
Granada, 18014, Spain
LEO Pharma Investigational Site
L'Hospitalet de Llobregat, 08907, Spain
LEO Pharma Investigational Site
Madrid, 28006, Spain
LEO Pharma Investigational Site
Madrid, 28031, Spain
LEO Pharma Investigational Site
Madrid, 28046, Spain
LEO Pharma Investigational Site
Madrid, 28922, Spain
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Pamplona, 31008, Spain
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Pontevedra, 36003, Spain
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Seville, 41007, Spain
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Valencia, 46014, Spain
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Valencia, 46026, Spain
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Birmingham, B15 2TH, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Cottingham, HU16 5JQ, United Kingdom
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Dudley, DY1 2HQ, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Harlow, CM20 1QX, United Kingdom
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Harrogate, HG2 7SX, United Kingdom
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Leytonstone, E11 1NR, United Kingdom
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London, N19 5NF, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE1 9RT, United Kingdom
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Redhill, RH1 5RH, United Kingdom
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Salford, M6 8HD, United Kingdom
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Sheffield, S10 2RX, United Kingdom
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Southampton, SO16 6YD, United Kingdom
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Wakefield, WF1 4DG, United Kingdom
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Walsall, WS2 9PS, United Kingdom
Related Publications (6)
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.
PMID: 35863467BACKGROUNDGuttman-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.
PMID: 38563683BACKGROUNDBlauvelt 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.
PMID: 36223087BACKGROUNDMayo 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.
PMID: 41118053DERIVEDReich 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.
PMID: 40879371DERIVEDChovatiya 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.
PMID: 40085349DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Disclosure
- Organization
- LEO Pharma A/S
Study Officials
- STUDY DIRECTOR
Medical expert
LEO Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2018
First Posted
July 16, 2018
Study Start
March 18, 2018
Primary Completion
July 3, 2024
Study Completion
July 3, 2024
Last Updated
March 11, 2025
Results First Posted
January 16, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share