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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000746-19 | EudraCT Number | ||
| U1111-1282-4519 | Other Identifier | World Health Organization (WHO) |
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The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tralokinumab, all subjects | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tralokinumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268) | From Week 0 up to Week 268 |
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Pharma Investigational Site | Birmingham | Alabama | 35209 | United States | ||
| LEO Pharma Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35863467 | Background | 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. | |
| 38563683 |
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This trial was conducted at 309 sites that screened subjects in 11 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tralokinumab, All Subjects | Week 0: subcutaneous (SC) injection of tralokinumab loading dose. From Week 2 up to Week 266*: SC injection of tralokinumab maintenance dose. *The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from. Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2022 | Dec 16, 2024 |
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| 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 |
| 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 |
| LEO Pharma Investigational Site | Fukushima | 960-1295 | Japan |
| LEO Pharma Investigational Site | Gifu | 501-1194 | Japan |
| LEO Pharma Investigational Site | Hamamatsu | 431-3192 | Japan |
| LEO Pharma Investigational Site | Hyōgo | 663-8186 | Japan |
| LEO Pharma Investigational Site | Hyōgo | 663-8501 | Japan |
| LEO Pharma Investigational Site | Ichinomiya | 491-8558 | Japan |
| LEO Pharma Investigational Site | Kagoshima | 890-8520 | Japan |
| LEO Pharma Investigational Site | Kyoto | 602-8566 | Japan |
| LEO Pharma Investigational Site | Morioka | 020-0066 | Japan |
| LEO Pharma Investigational Site | 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 |
| LEO Pharma Investigational Site | Tokyo | 105-8471 | Japan |
| LEO Pharma Investigational Site | Tokyo | 113-8603 | Japan |
| LEO Pharma Investigational Site | Tokyo | 160-0023 | Japan |
| LEO Pharma Investigational Site | Tokyo | 167-0035 | Japan |
| LEO Pharma Investigational Site | Toyama | 933-0871 | Japan |
| LEO Pharma Investigational Site | Bialystok | 15-375 | Poland |
| LEO Pharma Investigational Site | Bochnia | 32-700 | Poland |
| LEO Pharma Investigational Site | Bydgoszcz | 85-094 | Poland |
| LEO Pharma Investigational Site | Gdansk | 80-546 | Poland |
| LEO Pharma Investigational Site | Gdynia | 81-338 | Poland |
| LEO Pharma Investigational Site | Gdynia | 81-537 | Poland |
| LEO Pharma Investigational Site | Katowice | 40-040 | Poland |
| LEO Pharma Investigational Site | Krakow | 30-033 | Poland |
| LEO Pharma Investigational Site | Krakow | 30-149 | Poland |
| LEO Pharma Investigational Site | Krakow | 30-510 | Poland |
| LEO Pharma Investigational Site | Krakow | 31-011 | Poland |
| LEO Pharma Investigational Site | Krakow | 31-147 | Poland |
| LEO Pharma Investigational Site | Krakow | 31-501 | Poland |
| LEO Pharma Investigational Site | Krakow | 31-559 | Poland |
| LEO Pharma Investigational Site | Lodz | 90-242 | Poland |
| LEO Pharma Investigational Site | Lodz | 90-265 | Poland |
| LEO Pharma Investigational Site | Lodz | 90-436 | Poland |
| LEO Pharma Investigational Site | Lodz | 90-752 | Poland |
| LEO Pharma Investigational Site | Lublin | 20-081 | Poland |
| LEO Pharma Investigational Site | Lublin | 20-406 | Poland |
| LEO Pharma Investigational Site | Poznan | 60-369 | Poland |
| LEO Pharma Investigational Site | Poznan | 60-702 | Poland |
| LEO Pharma Investigational Site | Rzeszów | 35-055 | Poland |
| LEO Pharma Investigational Site | Rzeszów | 35-612 | Poland |
| LEO Pharma Investigational Site | Warsaw | 01-141 | Poland |
| LEO Pharma Investigational Site | Warsaw | 01-817 | Poland |
| LEO Pharma Investigational Site | Warsaw | 02-625 | Poland |
| LEO Pharma Investigational Site | Warsaw | 02-953 | Poland |
| LEO Pharma Investigational Site | Wroclaw | 51-318 | Poland |
| LEO Pharma Investigational Site | Wroclaw | 51-685 | Poland |
| LEO Pharma Investigational Site | Wroclaw | 52-416 | Poland |
| LEO Pharma Investigational Site | Alicante | 03010 | Spain |
| LEO Pharma Investigational Site | Badalona | 08915 | Spain |
| LEO Pharma Investigational Site | Barakaldo | 48903 | Spain |
| LEO Pharma Investigational Site | Barcelona | 08003 | Spain |
| LEO Pharma Investigational Site | Barcelona | 08036 | Spain |
| LEO Pharma Investigational Site | Barcelona | 08041 | Spain |
| LEO Pharma Investigational Site | Bilbao | 48013 | Spain |
| LEO Pharma Investigational Site | 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 |
| LEO Pharma Investigational Site | Pamplona | 31008 | Spain |
| LEO Pharma Investigational Site | Pontevedra | 36003 | Spain |
| LEO Pharma Investigational Site | Seville | 41007 | Spain |
| LEO Pharma Investigational Site | Valencia | 46014 | Spain |
| LEO Pharma Investigational Site | Valencia | 46026 | Spain |
| LEO Pharma Investigational Site | Birmingham | B15 2TH | United Kingdom |
| LEO Pharma Investigational Site | Cambridge | CB2 0QQ | United Kingdom |
| LEO Pharma Investigational Site | Cottingham | HU16 5JQ | United Kingdom |
| LEO Pharma Investigational Site | Dudley | DY1 2HQ | United Kingdom |
| LEO Pharma Investigational Site | Dundee | DD1 9SY | United Kingdom |
| LEO Pharma Investigational Site | Harlow | CM20 1QX | United Kingdom |
| LEO Pharma Investigational Site | Harrogate | HG2 7SX | United Kingdom |
| LEO Pharma Investigational Site | Leytonstone | E11 1NR | United Kingdom |
| LEO Pharma Investigational Site | London | N19 5NF | United Kingdom |
| LEO Pharma Investigational Site | London | NW3 2QG | United Kingdom |
| LEO Pharma Investigational Site | London | SE1 9RT | United Kingdom |
| LEO Pharma Investigational Site | Redhill | RH1 5RH | United Kingdom |
| LEO Pharma Investigational Site | Salford | M6 8HD | United Kingdom |
| LEO Pharma Investigational Site | Sheffield | S10 2RX | United Kingdom |
| LEO Pharma Investigational Site | Southampton | SO16 6YD | United Kingdom |
| LEO Pharma Investigational Site | Wakefield | WF1 4DG | United Kingdom |
| LEO Pharma Investigational Site | Walsall | WS2 9PS | United Kingdom |
| Background |
| 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. |
| 36223087 | Background | 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. |
| 41642555 | Derived | Blauvelt A, Hong HC, Katoh N, Langley RG, Laquer V, Lesiak A, Peris K, Seneschal J, Silvestre JF, Warren RB, Wollenberg A, Zirwas M, Bennike NH, Safavimanesh F, Tindberg AM, Reich K. Long-Term Safety and Efficacy of Tralokinumab in Patients with Moderate-to-Severe Atopic Dermatitis Treated for up to 6 Years: Final Results from the Open-Label Extension Trial ECZTEND. Dermatol Ther (Heidelb). 2026 Apr;16(4):2001-2018. doi: 10.1007/s13555-026-01656-7. Epub 2026 Feb 5. |
| 41118053 | Derived | Mayo T, Silverberg JI, Armstrong A, Guttman-Yassky E, Blauvelt A, Esdaile B, Kabashima K, Gooderham M, Kircik L, Schneider S, Bennike N, von Eyben R, Martel BC, Ropke MA, Katoh N, Alexis AF. Efficacy and Safety of Tralokinumab Across Racial Subgroups in Adults with Moderate-to-Severe Atopic Dermatitis: Post Hoc Analysis of Phase III Trials. Am J Clin Dermatol. 2026 Jan;27(1):149-166. doi: 10.1007/s40257-025-00985-1. Epub 2025 Oct 21. |
| 40879371 | Derived | Reich K, Langley RG, Silvestre Salvador JF, Staumont-Salle D, Costanzo A, Pink AE, Paller AS, Katoh N, Wollenberg A, Warren RB, Blauvelt A, Bjerregard Oland C, 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 eight clinical trials. Br J Dermatol. 2026 Jan 27;194(2):225-235. doi: 10.1093/bjd/ljaf309. |
| 40085349 | Derived | Chovatiya R, Ribero S, Wollenberg A, Park CO, Silvestre JF, Hong HC, Seneschal J, Saeki H, Thyssen JP, Oland CB, Gjerum L, Maslin D, Blauvelt A. Long-Term Disease Control and Minimal Disease Activity of Head and Neck Atopic Dermatitis in Patients Treated with Tralokinumab up to 4 Years. Am J Clin Dermatol. 2025 Jul;26(4):587-601. doi: 10.1007/s40257-025-00931-1. Epub 2025 Mar 14. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tralokinumab, All Subjects | Week 0: subcutaneous (SC) injection of tralokinumab loading dose. From Week 2 up to Week 266*: SC injection of tralokinumab maintenance dose. *The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from. Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight (kg) | Mean | Standard Deviation | Kg |
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| Height (cm) | Mean | Standard Deviation | cm |
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| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268) | Posted | Number | events | From Week 0 up to Week 268 |
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| 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). | Modified non-responder analysis with data multiply imputed using a hypothetical strategy. Response is based on observed and multiply imputed data. If a participant permanently discontinued IMP due to lack of efficacy or adverse event before the analyzed visit, they are considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of responders | From Week 16 up to Week 248 |
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| 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. | Modified non-responder analysis with data multiply imputed using a hypothetical strategy. Response is based on observed and multiply imputed data. If a participant permanently discontinued IMP due to lack of efficacy or adverse event before the analyzed visit, they are considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of responders | From Week 16 up to Week 248 |
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From baseline up to week 268
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tralokinumab, All Subjects | Week 0: subcutaneous (SC) injection of tralokinumab loading dose. From Week 2 up to Week 266: SC injection of tralokinumab maintenance dose. The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from. Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection. | 1 | 1,672 | 151 | 1,672 | 924 | 1,672 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Corneal dystrophy | Congenital, familial and genetic disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Atopic cataract | Eye disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Cataract nuclear | Eye disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Corneal disorder | Eye disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Vogt-Koyanagi-Harada disease | Eye disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Crohn disease | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Haemoperitoneum | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Proctitis ulcerative | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| cholelithiasis | Hepatobiliary disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Corneal graft rejection | Immune system disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Dermatitis infected | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Eczema herpeticum | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Encephalitis herpes | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Giardiasis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Herpes zoster pharyngitis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Medical device site joint infection | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Tonsilitis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Intervertebral protrusion | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Jaw cyst | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Adenoid cystic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Non-systematic Assessment |
| |
| Cutaneous T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Non-systematic Assessment |
| |
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Non-systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Non-systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Non-systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Non-systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Non-systematic Assessment |
| |
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (27.0) | Non-systematic Assessment |
| |
| ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (27.0) | Non-systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA (27.0) | Non-systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Bladder metaplasia | Renal and urinary disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Obstructive sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Cutaneous vasculitis | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Atopic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Alcohol detoxication | Surgical and medical procedures | MedDRA (27.0) | Non-systematic Assessment |
| |
| Cardiac resynchronisation therapy | Surgical and medical procedures | MedDRA (27.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjuctivitis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.0) | Non-systematic Assessment |
| |
| Atopic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Non-systematic Assessment |
|
The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure | LEO Pharma A/S | +45 44945888 | disclosure@leo-pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2024 | Dec 9, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C574065 | tralokinumab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Asian |
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| American indian or alaska native |
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| Native hawaiian or other pacific islander |
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| Other |
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| Missing |
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| United States |
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| Czechia |
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| Japan |
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| Poland |
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| Italy |
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| United Kingdom |
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| France |
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| Germany |
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| Spain |
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| Participants |
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