AzTrials
AzTrials

Atopic DermatitisPhase 3NCT03587805

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

A Phase 3 study testing Tralokinumab in people with Atopic Dermatitis, run by LEO Pharma at 309 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
Tralokinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,672 participants
Where
309 sitesin 11 countries
Study dates
18 Mar 2018to 3 Jul 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

309 sites in 11 countries.

309 sites in 11 countries

United States95 sites

  • LEO Pharma Investigational Site

    Albany, Georgia, 31707

  • LEO Pharma Investigational Site

    Ann Arbor, Michigan, 48103

  • LEO Pharma Investigational Site

    Austin, Texas, 78759

  • LEO Pharma Investigational Site

    Bakersfield, California, 93301

  • LEO Pharma Investigational Site

    Bangor, Maine, 04401

  • LEO Pharma Investigational Site

    Baton Rouge, Louisiana, 70808

  • LEO Pharma Investigational Site

    Bellaire, Texas, 77401

  • LEO Pharma Investigational Site

    Beverly Hills, California, 90212

  • LEO Pharma Investigational Site

    Bexley, Ohio, 43209

  • LEO Pharma Investigational Site

    Birmingham, Alabama, 35209

  • LEO Pharma Investigational Site

    Birmingham, Alabama, 35233

  • LEO Pharma Investigational Site

    Boston, Massachusetts, 02115

  • LEO Pharma Investigational Site

    Brighton, Massachusetts, 02135

  • LEO Pharma Investigational Site

    Buffalo, New York, 14203

  • LEO Pharma Investigational Site

    Chicago, Illinois, 60611

  • LEO Pharma Investigational Site

    Cincinnati, Ohio, 45219

  • LEO Pharma Investigational Site

    Cincinnati, Ohio, 45231

  • LEO Pharma Investigational Site

    Clarksville, Indiana, 47129

  • LEO Pharma Investigational Site

    Clearwater, Florida, 33756

  • LEO Pharma Investigational Site

    Columbus, Georgia, 31904

  • LEO Pharma Investigational Site

    Cortland, New York, 13045

  • LEO Pharma Investigational Site

    Dallas, Texas, 75225

  • LEO Pharma Investigational Site

    Detroit, Michigan, 48202

  • LEO Pharma Investigational Site

    Doral, Florida, 33122

  • LEO Pharma Investigational Site

    Dublin, Ohio, 43016

  • LEO Pharma Investigational Site

    East Windsor, New Jersey, 08520

  • LEO Pharma Investigational Site

    Encinitas, California, 92024

  • LEO Pharma Investigational Site

    Fairborn, Ohio, 45324

  • LEO Pharma Investigational Site

    Fort Smith, Arkansas, 72916

  • LEO Pharma Investigational Site

    Fountain Valley, California, 92708

  • LEO Pharma Investigational Site

    Fremont, California, 94538

  • LEO Pharma Investigational Site

    Frisco, Texas, 75034

  • LEO Pharma Investigational Site

    Fullerton, California, 92835

  • LEO Pharma Investigational Site

    Goodlettsville, Tennessee, 37072

  • LEO Pharma Investigational Site

    Henderson, Nevada, 89074

  • LEO Pharma Investigational Site

    Hialeah, Florida, 33012

  • LEO Pharma Investigational Site

    Horseheads, New York, 14845

  • LEO Pharma Investigational Site

    Houston, Texas, 77004

  • LEO Pharma Investigational Site

    Indianapolis, Indiana, 46250

  • LEO Pharma Investigational Site

    Kew Gardens, New York, 11415

  • LEO Pharma Investigational Site

    Lake Charles, Louisiana, 70601

  • LEO Pharma Investigational Site

    Los Angeles, California, 90025

  • LEO Pharma Investigational Site

    Los Angeles, California, 90033

  • LEO Pharma Investigational Site

    Los Angeles, California, 90045

  • LEO Pharma Investigational Site

    Louisville, Kentucky, 40215

  • LEO Pharma Investigational Site

    Louisville, Kentucky, 40217

  • LEO Pharma Investigational Site

    Macon, Georgia, 31217

  • LEO Pharma Investigational Site

    Miami, Florida, 33015

  • LEO Pharma Investigational Site 1

    Miami, Florida, 33144

  • LEO Pharma Investigational Site 2

    Miami, Florida, 33144

  • LEO Pharma Investigational Site

    Missoula, Montana, 59808

  • LEO Pharma Investigational Site

    Mobile, Alabama, 36695

  • LEO Pharma Investigational Site

    Morgantown, West Virginia, 26505

  • LEO Pharma Investigational Site

    New Haven, Connecticut, 06519

  • LEO Pharma Investigational Site

    New York, New York, 10021

  • LEO Pharma Investigational Site

    New York, New York, 10022

  • LEO Pharma Investigational Site

    New York, New York, 10028

  • LEO Pharma Investigational Site

    New York, New York, 10075

  • LEO Pharma Investigational Site

    Newnan, Georgia, 30263

  • LEO Pharma Investigational Site

    Newport Beach, California, 92660

  • LEO Pharma Investigational Site

    Norfolk, Virginia, 23502

  • LEO Pharma Investigational Site

    North Charleston, South Carolina, 29420

  • LEO Pharma Investigational Site

    North Miami Beach, Florida, 33162

  • LEO Pharma Investigational Site

    Northridge, California, 91324

  • LEO Pharma Investigational Site

    Orange Park, Florida, 32073

  • LEO Pharma Investigational Site

    Overland Park, Kansas, 66215

  • LEO Pharma Investigational Site

    Palo Alto, California, 94304

  • LEO Pharma Investigational Site

    Pflugerville, Texas, 78660

  • LEO Pharma Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • LEO Pharma Investigational Site

    Plainfield, Indiana, 46168

  • LEO Pharma Investigational Site

    Portland, Oregon, 97210

  • LEO Pharma Investigational Site

    Portland, Oregon, 97223

  • LEO Pharma Investigational Site

    Quincy, Massachusetts, 02169

  • LEO Pharma Investigational Site

    Raleigh, North Carolina, 27612

  • LEO Pharma Investigational Site

    Saint Joseph, Missouri, 64506

  • LEO Pharma Investigational Site

    San Antonio, Texas, 78213

  • LEO Pharma Investigational Site

    San Antonio, Texas, 78218

  • LEO Pharma Investigational Site

    San Diego, California, 92119

  • LEO Pharma Investigational Site

    San Diego, California, 92123

  • LEO Pharma Investigational Site

    San Francisco, California, 94132

  • LEO Pharma Investigational Site

    San Luis Obispo, California, 93405

  • LEO Pharma Investigational Site

    Santa Ana, California, 92701

  • LEO Pharma Investigational Site

    Santa Monica, California, 90404

  • LEO Pharma Investigational Site

    Savannah, Georgia, 31406

  • LEO Pharma Investigational Site

    South Burlington, Vermont, 05403

  • LEO Pharma Investigational Site

    Sweetwater, Florida, 33172

  • LEO Pharma Investigational Site

    Tampa, Florida, 33614

  • LEO Pharma Investigational Site

    Toledo, Ohio, 43617

  • LEO Pharma Investigational Site

    Troy, Michigan, 48084

  • LEO Pharma Investigational Site

    Tulsa, Oklahoma, 74136

  • LEO Pharma Investigational Site

    Webster, Texas, 77598

  • LEO Pharma Investigational Site

    West Bloomfield, Michigan, 48322

  • LEO Pharma Investigational Site

    West Palm Beach, Florida, 33401

  • LEO Pharma Investigational Site

    West Palm Beach, Florida, 33406

  • LEO Pharma Investigational Site

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan41 sites

  • LEO Pharma Investigational Site

    Asahikawa, Hokkaido, 070-8610

  • LEO Pharma Investigational Site

    Chikushino-shi, Fukuoka, 818-0083

  • LEO Pharma Investigational Site

    Chūōku, 060-0033

  • LEO Pharma Investigational Site

    Chūōku, 060-0063

  • LEO Pharma Investigational Site

    Fukuoka, Fukuoka, 814-0171

  • LEO Pharma Investigational Site

    Fukuoka, 814-0180

  • LEO Pharma Investigational Site

    Fukushima, 960-1295

  • LEO Pharma Investigational Site

    Gifu, 501-1194

  • LEO Pharma Investigational Site

    Hamamatsu, 431-3192

  • LEO Pharma Investigational Site

    Hyōgo, 663-8186

  • LEO Pharma Investigational Site

    Hyōgo, 663-8501

  • LEO Pharma Investigational Site

    Ichikawa-shi, Chiba, 272-0033

  • LEO Pharma Investigational Site

    Ichikawa-shi, Chiba, 272-0143

  • LEO Pharma Investigational Site

    Ichinomiya, 491-8558

  • LEO Pharma Investigational Site

    Kagoshima, Kagoshima-ken, 890-0063

  • LEO Pharma Investigational Site

    Kagoshima, 890-8520

  • LEO Pharma Investigational Site

    Kawasaki-shi, Kanagawa, 211-0063

  • LEO Pharma Investigational Site

    Koto-Ku, Tokyo, 136-0074

  • LEO Pharma Investigational Site

    Kyoto, 602-8566

  • LEO Pharma Investigational Site

    Minato-Ku, Tokyo, 108-0014

  • LEO Pharma Investigational Site

    Morioka, 020-0066

  • LEO Pharma Investigational Site

    Nagoya, 457-8510

  • LEO Pharma Investigational Site

    Nonoichi-shi, Ishikawa-ken, 921-8801

  • LEO Pharma Investigational Site

    Obihiro, 080-0013

  • LEO Pharma Investigational Site 2

    Osaka, 532-0003

  • LEO Pharma Investigational Site 1

    Osaka, 553-0003

  • LEO Pharma Investigational Site

    Osaka, 583-8588

  • LEO Pharma Investigational Site

    Osaka, 593-8324

  • LEO Pharma Investigational Site

    Sapporo, Hokkaido, 060-0807

  • LEO Pharma Investigational Site

    Sapporo, Hokkaido, 063-0812

  • LEO Pharma Investigational Site

    Setagaya-ku, Tokyo, 158-0097

  • LEO Pharma Investigational Site

    Shimotsuke-shi, 329-0498

  • LEO Pharma Investigational Site

    Shinjuku-Ku, Tokyo, 169-0075

  • LEO Pharma Investigational Site

    Tokyo, 105-8471

  • LEO Pharma Investigational Site

    Tokyo, 113-8603

  • LEO Pharma Investigational Site

    Tokyo, 160-0023

  • LEO Pharma Investigational Site

    Tokyo, 167-0035

  • LEO Pharma Investigational Site

    Toyama, 933-0871

  • LEO Pharma Investigational Site

    Toyonaka-shi, Osaka, 560-0085

  • LEO Pharma Investigational Site

    Yokohama, Kanagawa, 220-6208

  • LEO Pharma Investigational Site

    Yokohama, Kanagawa, 221-0825

Other trials in Japan

Canada38 sites

  • LEO Pharma Investigational Site

    Ajax, Ontario, L1S 7K8

  • LEO Pharma Investigational Site

    Bathurst, New Brunswick, E2A 4Z9

  • LEO Pharma Investigational Site

    Calgary, Alberta, T2J 7E1

  • LEO Pharma Investigational Site

    Calgary, Alberta, T3E 0B2

  • LEO Pharma Investigational Site

    Edmonton, Alberta, T5K 1X3

  • LEO Pharma Investigational Site

    Edmonton, Alberta, T6G 1C3

  • LEO Pharma Investigational Site

    Edmonton, Alberta, T6G 2B7

  • LEO Pharma Investigational Site

    Etobicoke, Ontario, M8X 1Y9

  • LEO Pharma Investigational Site

    Fredericton, New Brunswick, E3B 1G9

  • LEO Pharma Investigational Site

    Halifax, Nova Scotia, B3H 1Z2

  • LEO Pharma Investigational Site

    Hamilton, Ontario, L8S 1G5

  • LEO Pharma Investigational Site

    London, Ontario, N6A 3H7

  • LEO Pharma Investigational Site

    London, Ontario, N6H 5L5

  • LEO Pharma Investigational Site

    Markham, Ontario, L3P 1X3

  • LEO Pharma Investigational Site

    Mississauga, Ontario, L5H 1G9

  • LEO Pharma Investigational Site

    Montreal, Quebec, H3H 1V4

  • LEO Pharma Investigational Site

    North Bay, Ontario, P1B 3Z7

  • LEO Pharma Investigational Site

    Oakville, Ontario, L6J 7W5

  • LEO Pharma Investigational Site

    Ottawa, Ontario, K2C 3N2

  • LEO Pharma Investigational Site

    Peterborough, Ontario, K9J 5K2

  • LEO Pharma Investigational Site

    Québec, Quebec, G1V 4X7

  • LEO Pharma Investigational Site

    Richmond Hill, Ontario, L4B 1A5

  • LEO Pharma Investigational Site

    Richmond Hill, Ontario, L4C 9M7

  • LEO Pharma Investigational Site

    Saskatoon, Saskatchewan, S7K 0H6

  • LEO Pharma Investigational Site

    St. John's, Newfoundland and Labrador, A1A 4Y3

  • LEO Pharma Investigational Site

    Surrey, British Columbia, V3R 6A7

  • LEO Pharma Investigational Site

    Surrey, British Columbia, V3V 0C6

  • LEO Pharma Investigational Site

    Toronto, Ontario, M3B 3S6

  • LEO Pharma Investigational Site

    Toronto, Ontario, M4W 2N2

  • LEO Pharma Investigational Site

    Toronto, Ontario, M5A 3R6

  • LEO Pharma Investigational Site

    Vancouver, British Columbia, V5Z 4E8

  • LEO Pharma Investigational Site

    Vancouver, British Columbia, V6H 4E1

  • LEO Pharma Investigational Site

    Verdun, Quebec, H4G 3E7

  • LEO Pharma Investigational Site

    Waterloo, Ontario, N2J 1C4

  • LEO Pharma Investigational Site

    Windsor, Ontario, N8W 1E6

  • LEO Pharma Investigational Site

    Windsor, Ontario, N8X 2G1

  • LEO Pharma Investigational Site

    Winnipeg, Manitoba, R3C 0N2

  • LEO Pharma Investigational Site

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Poland31 sites

  • LEO Pharma Investigational Site

    Bialystok, 15-375

  • LEO Pharma Investigational Site

    Bochnia, 32-700

  • LEO Pharma Investigational Site

    Bydgoszcz, 85-094

  • LEO Pharma Investigational Site

    Gdansk, 80-546

  • LEO Pharma Investigational Site

    Gdynia, 81-338

  • LEO Pharma Investigational Site

    Gdynia, 81-537

  • LEO Pharma Investigational Site

    Katowice, 40-040

  • LEO Pharma Investigational Site

    Krakow, 30-033

  • LEO Pharma Investigational Site

    Krakow, 30-149

  • LEO Pharma Investigational Site

    Krakow, 30-510

  • LEO Pharma Investigational Site

    Krakow, 31-011

  • LEO Pharma Investigational Site

    Krakow, 31-147

  • LEO Pharma Investigational Site

    Krakow, 31-501

  • LEO Pharma Investigational Site

    Krakow, 31-559

  • LEO Pharma Investigational Site

    Lodz, 90-242

  • LEO Pharma Investigational Site

    Lodz, 90-265

  • LEO Pharma Investigational Site

    Lodz, 90-436

  • LEO Pharma Investigational Site

    Lodz, 90-752

  • LEO Pharma Investigational Site

    Lublin, 20-081

  • LEO Pharma Investigational Site

    Lublin, 20-406

  • LEO Pharma Investigational Site

    Poznan, 60-369

  • LEO Pharma Investigational Site

    Poznan, 60-702

  • LEO Pharma Investigational Site

    Rzeszów, 35-055

  • LEO Pharma Investigational Site

    Rzeszów, 35-612

  • LEO Pharma Investigational Site

    Warsaw, 01-141

  • LEO Pharma Investigational Site

    Warsaw, 01-817

  • LEO Pharma Investigational Site

    Warsaw, 02-625

  • LEO Pharma Investigational Site

    Warsaw, 02-953

  • LEO Pharma Investigational Site

    Wroclaw, 51-318

  • LEO Pharma Investigational Site

    Wroclaw, 51-685

  • LEO Pharma Investigational Site

    Wroclaw, 52-416

Other trials in Poland

Germany30 sites

  • LEO Pharma Investigational Site

    Aachen, 52074

  • LEO Pharma Investigational Site

    Augsburg, 86179

  • LEO Pharma Investigational Site

    Bad Bentheim, 48455

  • LEO Pharma Investigational Site

    Berlin, 10115

  • LEO Pharma Investigational Site

    Berlin, 10789

  • LEO Pharma Investigational Site

    Berlin, 12203

  • LEO Pharma Investigational Site

    Bielefeld, 33647

  • LEO Pharma Investigational Site

    Bochum, 44791

  • LEO Pharma Investigational Site

    Bochum, 44793

  • LEO Pharma Investigational Site

    Bonn, 53127

  • LEO Pharma Investigational Site

    Darmstadt, 64283

  • LEO Pharma Investigational Site

    Dresden, 01307

  • LEO Pharma Investigational Site

    Dülmen, 48249

  • LEO Pharma Investigational Site

    Erlangen, 91054

  • LEO Pharma Investigational Site

    Frankfurt am Main, 60590

  • LEO Pharma Investigational Site

    Friedrichshafen, 88045

  • LEO Pharma Investigational Site

    Gera, 07548

  • LEO Pharma Investigational Site

    Halle, 06097

  • LEO Pharma Investigational Site

    Hamburg, 20537

  • LEO Pharma Investigational Site

    Hamburg, 22391

  • LEO Pharma Investigational Site

    Hanover, 30159

  • LEO Pharma Investigational Site

    Jena, 07743

  • LEO Pharma Investigational Site

    Kiel, 24105

  • LEO Pharma Investigational Site

    Leipzig, 04103

  • LEO Pharma Investigational Site

    Mainz, 55128

  • LEO Pharma Investigational Site

    München, 80337

  • LEO Pharma Investigational Site

    Münster, 48149

  • LEO Pharma Investigational Site

    Osnabrück, 49074

  • LEO Pharma Investigational Site

    Selters, 56242

  • LEO Pharma Investigational Site

    Tübingen, 72076

Other trials in Germany

Spain20 sites

  • LEO Pharma Investigational Site

    Alicante, 03010

  • LEO Pharma Investigational Site

    Badalona, 08915

  • LEO Pharma Investigational Site

    Barakaldo, 48903

  • LEO Pharma Investigational Site

    Barcelona, 08003

  • LEO Pharma Investigational Site

    Barcelona, 08036

  • LEO Pharma Investigational Site

    Barcelona, 08041

  • LEO Pharma Investigational Site

    Bilbao, 48013

  • LEO Pharma Investigational Site

    Córdoba, 14004

  • LEO Pharma Investigational Site

    Fuenlabrada, 28942

  • LEO Pharma Investigational Site

    Granada, 18014

  • LEO Pharma Investigational Site

    L'Hospitalet de Llobregat, 08907

  • LEO Pharma Investigational Site

    Madrid, 28006

  • LEO Pharma Investigational Site

    Madrid, 28031

  • LEO Pharma Investigational Site

    Madrid, 28046

  • LEO Pharma Investigational Site

    Madrid, 28922

  • LEO Pharma Investigational Site

    Pamplona, 31008

  • LEO Pharma Investigational Site

    Pontevedra, 36003

  • LEO Pharma Investigational Site

    Seville, 41007

  • LEO Pharma Investigational Site

    Valencia, 46014

  • LEO Pharma Investigational Site

    Valencia, 46026

Other trials in Spain

United Kingdom17 sites

  • LEO Pharma Investigational Site

    Birmingham, B15 2TH

  • LEO Pharma Investigational Site

    Cambridge, CB2 0QQ

  • LEO Pharma Investigational Site

    Cottingham, HU16 5JQ

  • LEO Pharma Investigational Site

    Dudley, DY1 2HQ

  • LEO Pharma Investigational Site

    Dundee, DD1 9SY

  • LEO Pharma Investigational Site

    Harlow, CM20 1QX

  • LEO Pharma Investigational Site

    Harrogate, HG2 7SX

  • LEO Pharma Investigational Site

    Leytonstone, E11 1NR

  • LEO Pharma Investigational Site

    London, N19 5NF

  • LEO Pharma Investigational Site

    London, NW3 2QG

  • LEO Pharma Investigational Site

    London, SE1 9RT

  • LEO Pharma Investigational Site

    Redhill, RH1 5RH

  • LEO Pharma Investigational Site

    Salford, M6 8HD

  • LEO Pharma Investigational Site

    Sheffield, S10 2RX

  • LEO Pharma Investigational Site

    Southampton, SO16 6YD

  • LEO Pharma Investigational Site

    Wakefield, WF1 4DG

  • LEO Pharma Investigational Site

    Walsall, WS2 9PS

Other trials in United Kingdom

France14 sites

  • LEO Pharma Investigational Site

    Bordeaux, 33 075

  • LEO Pharma Investigational Site

    Dijon, 21079

  • LEO Pharma Investigational Site

    Grenoble, 38000

  • LEO Pharma Investigational Site

    Lille, 59000

  • LEO Pharma Investigational Site

    Marseille, Bouches-du-Rhône, 13285

  • LEO Pharma Investigational Site

    Martigues, 13500

  • LEO Pharma Investigational Site

    Mulhouse, 68100

  • LEO Pharma Investigational Site

    Nice, 06202

  • LEO Pharma Investigational Site

    Paris, 75010

  • LEO Pharma Investigational Site

    Pierre-Bénite, 69495

  • LEO Pharma Investigational Site

    Rouen, 76031

  • LEO Pharma Investigational Site

    Saint-Etienne, 42000

  • LEO Pharma Investigational Site

    Toulouse, 31000

  • LEO Pharma Investigational Site

    Valence, 26000

Other trials in France

Belgium11 sites

  • LEO Pharma Investigational Site

    Brussels, 1090

  • LEO Pharma Investigational Site

    Brussels, 1200

  • LEO Pharma Investigational Site

    Edegem, 2650

  • LEO Pharma Investigational Site

    Ghent, 9000

  • LEO Pharma Investigational Site

    Ghent, B-9000

  • LEO Pharma Investigational Site

    Herstal, B-4040

  • LEO Pharma Investigational Site

    Kortrijk, 8500

  • LEO Pharma Investigational Site

    Leuven, 3000

  • LEO Pharma Investigational Site

    Liège, 4000 LIEGE

  • LEO Pharma Investigational Site

    Loverval, 6280

  • LEO Pharma Investigational Site

    Maldegem, 9990

Other trials in Belgium

Czechia6 sites

  • LEO Pharma Investigational Site

    Karlovy Vary, 360 01

  • LEO Pharma Investigational Site

    Kutná Hora, 284 01

  • LEO Pharma Investigational Site

    Ostrava-Poruba, 708 52

  • LEO Pharma Investigational Site

    Pardubice, 530 02

  • LEO Pharma Investigational Site

    Prague, 100 00

  • LEO Pharma Investigational Site

    Prague, 110 00

Other trials in Czechia

Italy6 sites

  • LEO Pharma Investigational Site

    Brescia, 25123

  • LEO Pharma Investigational Site

    Catania, 95123

  • LEO Pharma Investigational Site

    L’Aquila, 67100

  • LEO Pharma Investigational Site

    Roma, 00144

  • LEO Pharma Investigational Site

    Roma, 00168

  • LEO Pharma Investigational Site

    Rozzano, 20089

Other trials in Italy

About this study

Official title: An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials

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

Being tested
Tralokinumab
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TralokinumabDrug

    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.

Study groups in NCT03587805
Study groupRoleWhat they receive
Tralokinumab, all subjectsExperimentalWeek 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.
Receives: Drug: Tralokinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268)

    Measured: From Week 0 up to Week 268

Secondary outcomes (2)

  1. 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).

    Measured: From Week 16 up to Week 248

  2. 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.

    Measured: From Week 16 up to Week 248

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2018
  2. Study start18 Mar 2018
  3. Primary completion3 Jul 2024
  4. Study completion3 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,672 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03587805
Sponsor's protocol ID
LP0162-1337
Other IDs
2018-000746-19, U1111-1282-4519, 2018
Status last verified
Dec 2024
First submitted
3 Jul 2018
Last updated
11 Mar 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 35863467

  • 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.

    PubMed 38563683

  • 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.

    PubMed 36223087

  • 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.

    PubMed 41642555

  • 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.

    PubMed 41118053

  • 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.

    PubMed 40879371

  • 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.

    PubMed 40085349

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tralokinumab in people with Atopic Dermatitis, run by LEO Pharma at 309 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 309 sites in United States, Japan, Canada, Poland, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268) (time frame: From Week 0 up to Week 268). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03587805, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.

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