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

March 6, 2024 updated by: LEO Pharma

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

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

Study Overview

Status

Active, not recruiting

Conditions

Atopic Dermatitis

Intervention / Treatment

Drug: Tralokinumab

Study Type

Interventional

Enrollment (Actual)

1672

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Brussel, Belgium, 1090
    - LEO Pharma Investigational Site
  - Brussels, Belgium, 1200
    - LEO Pharma Investigational Site
  - Edegem, Belgium, 2650
    - LEO Pharma Investigational Site
  - Gent, Belgium, 9000
    - LEO Pharma Investigational Site
  - Gent, Belgium, B-9000
    - LEO Pharma Investigational Site
  - Herstal, Belgium, B-4040
    - LEO Pharma Investigational Site
  - Kortrijk, Belgium, 8500
    - LEO Pharma Investigational Site
  - Leuven, Belgium, 3000
    - LEO Pharma Investigational Site
  - Liège, Belgium, 4000 LIEGE
    - LEO Pharma Investigational Site
  - Loverval, Belgium, 6280
    - LEO Pharma Investigational Site
  - Maldegem, Belgium, 9990
    - LEO Pharma Investigational Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T2J 7E1
    - LEO Pharma Investigational Site
  - Calgary, Alberta, Canada, T3E 0B2
    - LEO Pharma Investigational Site
  - Edmonton, Alberta, Canada, T5K 1X3
    - LEO Pharma Investigational Site
  - Edmonton, Alberta, Canada, T6G 1C3
    - LEO Pharma Investigational Site
  - Edmonton, Alberta, Canada, T6G 2B7
    - LEO Pharma Investigational Site
- British Columbia
  - Surrey, British Columbia, Canada, V3R 6A7
    - LEO Pharma Investigational Site
  - Surrey, British Columbia, Canada, V3V 0C6
    - LEO Pharma Investigational Site
  - Vancouver, British Columbia, Canada, V5Z 4E8
    - LEO Pharma Investigational Site
  - Vancouver, British Columbia, Canada, V6H 4E1
    - LEO Pharma Investigational Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3C 0N2
    - LEO Pharma Investigational Site
  - Winnipeg, Manitoba, Canada, R3M 3Z4
    - LEO Pharma Investigational Site
- New Brunswick
  - Bathurst, New Brunswick, Canada, E2A 4Z9
    - LEO Pharma Investigational Site
  - Fredericton, New Brunswick, Canada, E3B 1G9
    - LEO Pharma Investigational Site
- Newfoundland and Labrador
  - Saint John's, Newfoundland and Labrador, Canada, A1A 4Y3
    - LEO Pharma Investigational Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1Z2
    - LEO Pharma Investigational Site
- Ontario
  - Ajax, Ontario, Canada, L1S 7K8
    - LEO Pharma Investigational Site
  - Etobicoke, Ontario, Canada, M8X 1Y9
    - LEO Pharma Investigational Site
  - Hamilton, Ontario, Canada, L8S 1G5
    - LEO Pharma Investigational Site
  - London, Ontario, Canada, N6A 3H7
    - LEO Pharma Investigational Site
  - London, Ontario, Canada, N6H 5L5
    - LEO Pharma Investigational Site
  - Markham, Ontario, Canada, L3P 1X3
    - LEO Pharma Investigational Site
  - Mississauga, Ontario, Canada, L5H 1G9
    - LEO Pharma Investigational Site
  - North Bay, Ontario, Canada, P1B 3Z7
    - LEO Pharma Investigational Site
  - Oakville, Ontario, Canada, L6J 7W5
    - LEO Pharma Investigational Site
  - Ottawa, Ontario, Canada, K2C 3N2
    - LEO Pharma Investigational Site
  - Peterborough, Ontario, Canada, K9J 5K2
    - LEO Pharma Investigational Site
  - Richmond Hill, Ontario, Canada, L4B 1A5
    - LEO Pharma Investigational Site
  - Richmond Hill, Ontario, Canada, L4C 9M7
    - LEO Pharma Investigational Site
  - Toronto, Ontario, Canada, M3B 3S6
    - LEO Pharma Investigational Site
  - Toronto, Ontario, Canada, M4W 2N2
    - LEO Pharma Investigational Site
  - Toronto, Ontario, Canada, M5A 3R6
    - LEO Pharma Investigational Site
  - Waterloo, Ontario, Canada, N2J 1C4
    - LEO Pharma Investigational Site
  - Windsor, Ontario, Canada, N8W 1E6
    - LEO Pharma Investigational Site
  - Windsor, Ontario, Canada, N8X 2G1
    - LEO Pharma Investigational Site
- Quebec
  - Montreal, Quebec, Canada, H3H 1V4
    - LEO Pharma Investigational Site
  - Québec, Quebec, Canada, G1V 4X7
    - LEO Pharma Investigational Site
  - Verdun, Quebec, Canada, H4G 3E7
    - LEO Pharma Investigational Site
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7K 0H6
    - LEO Pharma Investigational Site
Czechia
- - Karlovy Vary, Czechia, 360 01
    - LEO Pharma Investigational Site
  - Kutná Hora, Czechia, 284 01
    - LEO Pharma Investigational Site
  - Ostrava-Poruba, Czechia, 708 52
    - LEO Pharma Investigational Site
  - Pardubice, Czechia, 530 02
    - LEO Pharma Investigational Site
  - Prague, Czechia, 100 00
    - LEO Pharma Investigational Site
  - Prague, Czechia, 110 00
    - LEO Pharma Investigational Site
France
- - Bordeaux, France, 33 075
    - LEO Pharma Investigational Site
  - Dijon, France, 21079
    - LEO Pharma Investigational Site
  - Grenoble, France, 38000
    - LEO Pharma Investigational Site
  - Lille, France, 59000
    - LEO Pharma Investigational Site
  - Martigues, France, 13500
    - LEO Pharma Investigational Site
  - Mulhouse, France, 68100
    - LEO Pharma Investigational Site
  - Nice, France, 06202
    - LEO Pharma Investigational Site
  - Paris, France, 75010
    - LEO Pharma Investigational Site
  - Pierre-Bénite, France, 69495
    - LEO Pharma Investigational Site
  - Rouen, France, 76031
    - LEO Pharma Investigational Site
  - Saint-Étienne, France, 42000
    - LEO Pharma Investigational Site
  - Toulouse, France, 31000
    - LEO Pharma Investigational Site
  - Valence, France, 26000
    - LEO Pharma Investigational Site
- Bouches-du-Rhône
  - Marseille, Bouches-du-Rhône, France, 13285
    - LEO Pharma Investigational Site
Germany
- - Aachen, Germany, 52074
    - LEO Pharma Investigational Site
  - Augsburg, Germany, 86179
    - LEO Pharma Investigational Site
  - Bad Bentheim, Germany, 48455
    - LEO Pharma Investigational Site
  - Berlin, Germany, 10115
    - LEO Pharma Investigational Site
  - Berlin, Germany, 10789
    - LEO Pharma Investigational Site
  - Berlin, Germany, 12203
    - LEO Pharma Investigational Site
  - Bielefeld, Germany, 33647
    - LEO Pharma Investigational Site
  - Bochum, Germany, 44791
    - LEO Pharma Investigational Site
  - Bochum, Germany, 44793
    - LEO Pharma Investigational Site
  - Bonn, Germany, 53127
    - LEO Pharma Investigational Site
  - Darmstadt, Germany, 64283
    - LEO Pharma Investigational Site
  - Dresden, Germany, 01307
    - LEO Pharma Investigational Site
  - Dülmen, Germany, 48249
    - LEO Pharma Investigational Site
  - Erlangen, Germany, 91054
    - LEO Pharma Investigational Site
  - Frankfurt am Main, Germany, 60590
    - LEO Pharma Investigational Site
  - Friedrichshafen, Germany, 88045
    - LEO Pharma Investigational Site
  - Gera, Germany, 07548
    - LEO Pharma Investigational Site
  - Halle, Germany, 06097
    - LEO Pharma Investigational Site
  - Hamburg, Germany, 20537
    - LEO Pharma Investigational Site
  - Hamburg, Germany, 22391
    - LEO Pharma Investigational Site
  - Hanover, Germany, 30159
    - LEO Pharma Investigational Site
  - Jena, Germany, 07743
    - LEO Pharma Investigational Site
  - Kiel, Germany, 24105
    - LEO Pharma Investigational Site
  - Leipzig, Germany, 04103
    - LEO Pharma Investigational Site
  - Mainz, Germany, 55128
    - LEO Pharma Investigational Site
  - München, Germany, 80337
    - LEO Pharma Investigational Site
  - Münster, Germany, 48149
    - LEO Pharma Investigational Site
  - Osnabrück, Germany, 49074
    - LEO Pharma Investigational Site
  - Selters, Germany, 56242
    - LEO Pharma Investigational Site
  - Tübingen, Germany, 72076
    - LEO Pharma Investigational Site
Italy
- - Brescia, Italy, 25123
    - LEO Pharma Investigational Site
  - Catania, Italy, 95123
    - LEO Pharma Investigational Site
  - L'Aquila, Italy, 67100
    - LEO Pharma Investigational Site
  - Roma, Italy, 00144
    - LEO Pharma Investigational Site
  - Roma, Italy, 00168
    - LEO Pharma Investigational Site
  - Rozzano, Italy, 20089
    - LEO Pharma Investigational Site
Japan
- - Chuo Ku, Japan, 060-0033
    - LEO Pharma Investigational Site
  - Chuo Ku, Japan, 060-0063
    - LEO Pharma Investigational Site
  - Fukuoka, Japan, 814-0180
    - LEO Pharma Investigational Site
  - Fukushima, Japan, 960-1295
    - LEO Pharma Investigational Site
  - Gifu, Japan, 501-1194
    - LEO Pharma Investigational Site
  - Hamamatsu, Japan, 431-3192
    - LEO Pharma Investigational Site
  - Hyōgo, Japan, 663-8186
    - LEO Pharma Investigational Site
  - Hyōgo, Japan, 663-8501
    - LEO Pharma Investigational Site
  - Ichinomiya, Japan, 491-8558
    - LEO Pharma Investigational Site
  - Kagoshima, Japan, 890-8520
    - LEO Pharma Investigational Site
  - Kyoto, Japan, 602-8566
    - LEO Pharma Investigational Site
  - Morioka City, Japan, 020-0066
    - LEO Pharma Investigational Site
  - Nagoya-shi, Japan, 457-8510
    - LEO Pharma Investigational Site
  - Obihiro, Japan, 080-0013
    - LEO Pharma Investigational Site
  - Osaka, Japan, 532-0003
    - LEO Pharma Investigational Site 2
  - Osaka, Japan, 553-0003
    - LEO Pharma Investigational Site 1
  - Osaka, Japan, 583-8588
    - LEO Pharma Investigational Site
  - Osaka, Japan, 593-8324
    - LEO Pharma Investigational Site
  - Shimotsuke-shi, Japan, 329-0498
    - LEO Pharma Investigational Site
  - Tokyo, Japan, 105-8471
    - LEO Pharma Investigational Site
  - Tokyo, Japan, 113-8603
    - LEO Pharma Investigational Site
  - Tokyo, Japan, 160-0023
    - LEO Pharma Investigational Site
  - Tokyo, Japan, 167-0035
    - LEO Pharma Investigational Site
  - Toyama, Japan, 933-0871
    - LEO Pharma Investigational Site
- Chiba
  - Ichikawa-shi, Chiba, Japan, 272-0033
    - LEO Pharma Investigational Site
  - Ichikawa-shi, Chiba, Japan, 272-0143
    - LEO Pharma Investigational Site
- Fukuoka
  - Chikushino-shi, Fukuoka, Japan, 818-0083
    - LEO Pharma Investigational Site
  - Fukuoka-shi, Fukuoka, Japan, 814-0171
    - LEO Pharma Investigational Site
- Hokkaido
  - Asahikawa, Hokkaido, Japan, 070-8610
    - LEO Pharma Investigational Site
  - Sapporo-shi, Hokkaido, Japan, 060-0807
    - LEO Pharma Investigational Site
  - Sapporo-shi, Hokkaido, Japan, 063-0812
    - LEO Pharma Investigational Site
- Ishikawa
  - Nonoichi-shi, Ishikawa, Japan, 921-8801
    - LEO Pharma Investigational Site
- Kagoshima
  - Kagoshima-shi, Kagoshima, Japan, 890-0063
    - LEO Pharma Investigational Site
- Kanagawa
  - Kawasaki-shi, Kanagawa, Japan, 211-0063
    - LEO Pharma Investigational Site
  - Yokohama-shi, Kanagawa, Japan, 220-6208
    - LEO Pharma Investigational Site
  - Yokohama-shi, Kanagawa, Japan, 221-0825
    - LEO Pharma Investigational Site
- Osaka
  - Toyonaka-shi, Osaka, Japan, 560-0085
    - LEO Pharma Investigational Site
- Tokyo
  - Koto-Ku, Tokyo, Japan, 136-0074
    - LEO Pharma Investigational Site
  - Minato-Ku, Tokyo, Japan, 108-0014
    - LEO Pharma Investigational Site
  - Setagaya-ku, Tokyo, Japan, 158-0097
    - LEO Pharma Investigational Site
  - Shinjuku-Ku, Tokyo, Japan, 169-0075
    - LEO Pharma Investigational Site
Poland
- - Białystok, Poland, 15-375
    - LEO Pharma Investigational Site
  - Bochnia, Poland, 32-700
    - LEO Pharma Investigational Site
  - Bydgoszcz, Poland, 85-094
    - LEO Pharma Investigational Site
  - Gdańsk, Poland, 80-546
    - LEO Pharma Investigational Site
  - Gdynia, Poland, 81-338
    - LEO Pharma Investigational Site
  - Gdynia, Poland, 81-537
    - LEO Pharma Investigational Site
  - Katowice, Poland, 40-040
    - LEO Pharma Investigational Site
  - Kraków, Poland, 30-033
    - LEO Pharma Investigational Site
  - Kraków, Poland, 30-149
    - LEO Pharma Investigational Site
  - Kraków, Poland, 30-510
    - LEO Pharma Investigational Site
  - Kraków, Poland, 31-011
    - LEO Pharma Investigational Site
  - Kraków, Poland, 31-147
    - LEO Pharma Investigational Site
  - Kraków, Poland, 31-501
    - LEO Pharma Investigational Site
  - Kraków, Poland, 31-559
    - LEO Pharma Investigational Site
  - Lublin, Poland, 20-081
    - LEO Pharma Investigational Site
  - Lublin, Poland, 20-406
    - LEO Pharma Investigational Site
  - Poznań, Poland, 60-369
    - LEO Pharma Investigational Site
  - Poznań, Poland, 60-702
    - LEO Pharma Investigational Site
  - Rzeszów, Poland, 35-055
    - LEO Pharma Investigational Site
  - Rzeszów, Poland, 35-612
    - LEO Pharma Investigational Site
  - Warszawa, Poland, 01-141
    - LEO Pharma Investigational Site
  - Warszawa, Poland, 01-817
    - LEO Pharma Investigational Site
  - Warszawa, Poland, 02-625
    - LEO Pharma Investigational Site
  - Warszawa, Poland, 02-953
    - LEO Pharma Investigational Site
  - Wrocław, Poland, 51-318
    - LEO Pharma Investigational Site
  - Wrocław, Poland, 51-685
    - LEO Pharma Investigational Site
  - Wrocław, Poland, 52-416
    - LEO Pharma Investigational Site
  - Łódź, Poland, 90-242
    - LEO Pharma Investigational Site
  - Łódź, Poland, 90-265
    - LEO Pharma Investigational Site
  - Łódź, Poland, 90-436
    - LEO Pharma Investigational Site
  - Łódź, Poland, 90-752
    - LEO Pharma Investigational Site
Spain
- - Alicante, Spain, 03010
    - LEO Pharma Investigational Site
  - Badalona, Spain, 08915
    - LEO Pharma Investigational Site
  - Barakaldo, Spain, 48903
    - LEO Pharma Investigational Site
  - Barcelona, Spain, 08003
    - LEO Pharma Investigational Site
  - Barcelona, Spain, 08036
    - LEO Pharma Investigational Site
  - Barcelona, Spain, 08041
    - LEO Pharma Investigational Site
  - Bilbao, Spain, 48013
    - LEO Pharma Investigational Site
  - Cordoba, Spain, 14004
    - LEO Pharma Investigational Site
  - Fuenlabrada, Spain, 28942
    - LEO Pharma Investigational Site
  - Granada, Spain, 18014
    - LEO Pharma Investigational Site
  - L'Hospitalet De Llobregat, Spain, 08907
    - LEO Pharma Investigational Site
  - Madrid, Spain, 28006
    - LEO Pharma Investigational Site
  - Madrid, Spain, 28031
    - LEO Pharma Investigational Site
  - Madrid, Spain, 28046
    - LEO Pharma Investigational Site
  - Madrid, Spain, 28922
    - LEO Pharma Investigational Site
  - Pamplona, Spain, 31008
    - LEO Pharma Investigational Site
  - Pontevedra, Spain, 36003
    - LEO Pharma Investigational Site
  - Sevilla, Spain, 41007
    - LEO Pharma Investigational Site
  - Valencia, Spain, 46014
    - LEO Pharma Investigational Site
  - Valencia, Spain, 46026
    - LEO Pharma Investigational Site
United Kingdom
- - Birmingham, United Kingdom, B15 2TH
    - LEO Pharma Investigational Site
  - Cambridge, United Kingdom, CB2 0QQ
    - LEO Pharma Investigational Site
  - Cottingham, United Kingdom, HU16 5JQ
    - LEO Pharma Investigational Site
  - Dudley, United Kingdom, DY1 2HQ
    - LEO Pharma Investigational Site
  - Dundee, United Kingdom, DD1 9SY
    - LEO Pharma Investigational Site
  - Harlow, United Kingdom, CM20 1QX
    - LEO Pharma Investigational Site
  - Harrogate, United Kingdom, HG2 7SX
    - LEO Pharma Investigational Site
  - Leytonstone, United Kingdom, E11 1NR
    - LEO Pharma Investigational Site
  - London, United Kingdom, N19 5NF
    - LEO Pharma Investigational Site
  - London, United Kingdom, NW3 2QG
    - LEO Pharma Investigational Site
  - London, United Kingdom, SE1 9RT
    - LEO Pharma Investigational Site
  - Redhill, United Kingdom, RH1 5RH
    - LEO Pharma Investigational Site
  - Salford, United Kingdom, M6 8HD
    - LEO Pharma Investigational Site
  - Sheffield, United Kingdom, S10 2RX
    - LEO Pharma Investigational Site
  - Southampton, United Kingdom, SO16 6YD
    - LEO Pharma Investigational Site
  - Wakefield, United Kingdom, WF1 4DG
    - LEO Pharma Investigational Site
  - Walsall, United Kingdom, WS2 9PS
    - LEO Pharma Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - LEO Pharma Investigational Site
  - Birmingham, Alabama, United States, 35233
    - LEO Pharma Investigational Site
  - Mobile, Alabama, United States, 36695
    - LEO Pharma Investigational Site
- Arkansas
  - Fort Smith, Arkansas, United States, 72916
    - LEO Pharma Investigational Site
- California
  - Bakersfield, California, United States, 93301
    - LEO Pharma Investigational Site
  - Beverly Hills, California, United States, 90212
    - LEO Pharma Investigational Site
  - Encinitas, California, United States, 92024
    - LEO Pharma Investigational Site
  - Fountain Valley, California, United States, 92708
    - LEO Pharma Investigational Site
  - Fremont, California, United States, 94538
    - LEO Pharma Investigational Site
  - Fullerton, California, United States, 92835
    - LEO Pharma Investigational Site
  - Los Angeles, California, United States, 90025
    - LEO Pharma Investigational Site
  - Los Angeles, California, United States, 90033
    - LEO Pharma Investigational Site
  - Los Angeles, California, United States, 90045
    - LEO Pharma Investigational Site
  - Newport Beach, California, United States, 92660
    - LEO Pharma Investigational Site
  - Northridge, California, United States, 91324
    - LEO Pharma Investigational Site
  - Palo Alto, California, United States, 94304
    - LEO Pharma Investigational Site
  - San Diego, California, United States, 92119
    - LEO Pharma Investigational Site
  - San Diego, California, United States, 92123
    - LEO Pharma Investigational Site
  - San Francisco, California, United States, 94132
    - LEO Pharma Investigational Site
  - San Luis Obispo, California, United States, 93405
    - LEO Pharma Investigational Site
  - Santa Ana, California, United States, 92701
    - LEO Pharma Investigational Site
  - Santa Monica, California, United States, 90404
    - LEO Pharma Investigational Site
- Connecticut
  - New Haven, Connecticut, United States, 06519
    - LEO Pharma Investigational Site
- Florida
  - Clearwater, Florida, United States, 33756
    - LEO Pharma Investigational Site
  - Doral, Florida, United States, 33122
    - LEO Pharma Investigational Site
  - Hialeah, Florida, United States, 33012
    - LEO Pharma Investigational Site
  - Miami, Florida, United States, 33015
    - LEO Pharma Investigational Site
  - Miami, Florida, United States, 33144
    - LEO Pharma Investigational Site 1
  - Miami, Florida, United States, 33144
    - LEO Pharma Investigational Site 2
  - North Miami Beach, Florida, United States, 33162
    - LEO Pharma Investigational Site
  - Orange Park, Florida, United States, 32073
    - LEO Pharma Investigational Site
  - Sweetwater, Florida, United States, 33172
    - LEO Pharma Investigational Site
  - Tampa, Florida, United States, 33614
    - LEO Pharma Investigational Site
  - West Palm Beach, Florida, United States, 33401
    - LEO Pharma Investigational Site
  - West Palm Beach, Florida, United States, 33406
    - LEO Pharma Investigational Site
- Georgia
  - Albany, Georgia, United States, 31707
    - LEO Pharma Investigational Site
  - Columbus, Georgia, United States, 31904
    - LEO Pharma Investigational Site
  - Macon, Georgia, United States, 31217
    - LEO Pharma Investigational Site
  - Newnan, Georgia, United States, 30263
    - LEO Pharma Investigational Site
  - Savannah, Georgia, United States, 31406
    - LEO Pharma Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - LEO Pharma Investigational Site
- Indiana
  - Clarksville, Indiana, United States, 47129
    - LEO Pharma Investigational Site
  - Indianapolis, Indiana, United States, 46250
    - LEO Pharma Investigational Site
  - Plainfield, Indiana, United States, 46168
    - LEO Pharma Investigational Site
- Kansas
  - Overland Park, Kansas, United States, 66215
    - LEO Pharma Investigational Site
- Kentucky
  - Louisville, Kentucky, United States, 40215
    - LEO Pharma Investigational Site
  - Louisville, Kentucky, United States, 40217
    - LEO Pharma Investigational Site
- Louisiana
  - Baton Rouge, Louisiana, United States, 70808
    - LEO Pharma Investigational Site
  - Lake Charles, Louisiana, United States, 70601
    - LEO Pharma Investigational Site
- Maine
  - Bangor, Maine, United States, 04401
    - LEO Pharma Investigational Site
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - LEO Pharma Investigational Site
  - Brighton, Massachusetts, United States, 02135
    - LEO Pharma Investigational Site
  - Quincy, Massachusetts, United States, 02169
    - LEO Pharma Investigational Site
- Michigan
  - Ann Arbor, Michigan, United States, 48103
    - LEO Pharma Investigational Site
  - Detroit, Michigan, United States, 48202
    - LEO Pharma Investigational Site
  - Troy, Michigan, United States, 48084
    - LEO Pharma Investigational Site
  - West Bloomfield, Michigan, United States, 48322
    - LEO Pharma Investigational Site
  - Ypsilanti, Michigan, United States, 48197
    - LEO Pharma Investigational Site
- Missouri
  - Saint Joseph, Missouri, United States, 64506
    - LEO Pharma Investigational Site
- Montana
  - Missoula, Montana, United States, 59808
    - LEO Pharma Investigational Site
- Nevada
  - Henderson, Nevada, United States, 89074
    - LEO Pharma Investigational Site
- New Jersey
  - East Windsor, New Jersey, United States, 08520
    - LEO Pharma Investigational Site
- New York
  - Buffalo, New York, United States, 14203
    - LEO Pharma Investigational Site
  - Cortland, New York, United States, 13045
    - LEO Pharma Investigational Site
  - Horseheads, New York, United States, 14845
    - LEO Pharma Investigational Site
  - Kew Gardens, New York, United States, 11415
    - LEO Pharma Investigational Site
  - New York, New York, United States, 10021
    - LEO Pharma Investigational Site
  - New York, New York, United States, 10022
    - LEO Pharma Investigational Site
  - New York, New York, United States, 10028
    - LEO Pharma Investigational Site
  - New York, New York, United States, 10075
    - LEO Pharma Investigational Site
- North Carolina
  - Raleigh, North Carolina, United States, 27612
    - LEO Pharma Investigational Site
- Ohio
  - Bexley, Ohio, United States, 43209
    - LEO Pharma Investigational Site
  - Cincinnati, Ohio, United States, 45219
    - LEO Pharma Investigational Site
  - Cincinnati, Ohio, United States, 45231
    - LEO Pharma Investigational Site
  - Dublin, Ohio, United States, 43016
    - LEO Pharma Investigational Site
  - Fairborn, Ohio, United States, 45324
    - LEO Pharma Investigational Site
  - Toledo, Ohio, United States, 43617
    - LEO Pharma Investigational Site
- Oklahoma
  - Tulsa, Oklahoma, United States, 74136
    - LEO Pharma Investigational Site
- Oregon
  - Portland, Oregon, United States, 97210
    - LEO Pharma Investigational Site
  - Portland, Oregon, United States, 97223
    - LEO Pharma Investigational Site
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15213
    - LEO Pharma Investigational Site
- South Carolina
  - North Charleston, South Carolina, United States, 29420
    - LEO Pharma Investigational Site
- Tennessee
  - Goodlettsville, Tennessee, United States, 37072
    - LEO Pharma Investigational Site
- Texas
  - Austin, Texas, United States, 78759
    - LEO Pharma Investigational Site
  - Bellaire, Texas, United States, 77401
    - LEO Pharma Investigational Site
  - Dallas, Texas, United States, 75225
    - LEO Pharma Investigational Site
  - Frisco, Texas, United States, 75034
    - LEO Pharma Investigational Site
  - Houston, Texas, United States, 77004
    - LEO Pharma Investigational Site
  - Pflugerville, Texas, United States, 78660
    - LEO Pharma Investigational Site
  - San Antonio, Texas, United States, 78213
    - LEO Pharma Investigational Site
  - San Antonio, Texas, United States, 78218
    - LEO Pharma Investigational Site
  - Webster, Texas, United States, 77598
    - LEO Pharma Investigational Site
- Vermont
  - South Burlington, Vermont, United States, 05403
    - LEO Pharma Investigational Site
- Virginia
  - Norfolk, Virginia, United States, 23502
    - LEO Pharma Investigational Site
- West Virginia
  - Morgantown, West Virginia, United States, 26505
    - LEO Pharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events from baseline through the last treatment visit (up to Week 268) Time Frame: From Week 0 up to Week 268	From Week 0 up to Week 268

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Time Frame: From Week 16 up to Week 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
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 Time Frame: From Week 16 up to Week 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

Study Director: Medical Expert, LEO Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2018

Primary Completion (Estimated)

June 28, 2024

Study Completion (Estimated)

June 13, 2025

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 16, 2018

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

LP0162-1337
2018-000746-19 (EudraCT Number)
U1111-1282-4519 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

IPD Sharing Time Frame

Data is available to request after results of the trial are available on leopharmatrials.com

IPD Sharing Access Criteria

Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Atopic Dermatitis

Clinical Trials on Tralokinumab

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