AzTrials
AzTrials

Atopic DermatitisPhase 3NCT01949311

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

A Phase 3 study testing Dupilumab in people with Atopic Dermatitis, run by Regeneron Pharmaceuticals at 432 sites in 28 countries.

Completed

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

Official record
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Trial summary

The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
Dupilumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,733 participants
Where
432 sitesin 28 countries
Study dates
10 Oct 2013to 27 Jun 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participation in a prior clinical trial of dupilumab for AD and met one of the following:
  • Received study treatment and adequately completed the assessments required for both the treatment and follow-up periods of the parent studies (except studies listed in b) as defined in the parent protocols
  • Received study treatment in one the studies that have completed last patient, last visit irrespective of duration of participation, provided that patients completed with the instructions received during the study.
  • Underwent screening in R668-AD-1334 (Liberty AD SOLO 1) or R668-AD-1416 (Liberty AD SOLO 2) but could not be randomized due to randomization closure.
  • Willing and able to comply with all clinic visits and study-related procedures
  • Able to understand and complete study-related questionnaires
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  • Provide signed informed consent
  • Optional Sub-Study:
  • Provide separate informed consent
  • Continuing in the treatment period of the main OLE study
  • Demonstrated compliance with dupilumab therapy, as defined in the protocol

Who cannot join

  • Patients who, during their participation in a previous dupilumab clinical trial, developed a serious adverse event (SAE) deemed related to dupilumab*, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
  • Patients who, during their participation in a previous dupilumab clinical trial, developed an AE that was deemed related to dupilumab* and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
  • Conditions in the previous dupilumab study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to dupilumab* or led to investigator - or sponsor-initiated withdrawal of patient from the study (eg, non-compliance, inability to complete study assessments, etc.).
  • Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded, conditions deemed related to the study treatment will be considered related to dupilumab.
  • Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
  • Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the patient's participation in this study
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  • Optional Sub-Study:
  • 1. Patients who have already completed the end of treatment visit (ie, visit 44) for the main study R668-AD-1225
  • Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply.

Trial locations and contacts

432 sites in 28 countries.

432 sites in 28 countries

United States129 sites

  • Regeneron Study Site 1

    Albuquerque, New Mexico, 87106

  • Regeneron Study Site 2

    Albuquerque, New Mexico, 87106

  • Regeneron Study Site

    Alpharetta, Georgia, 30022

  • Regeneron Study Site

    Anniston, Alabama, 36207

  • Regeneron Study Site

    Arlington, Texas, 76011

  • Regeneron Study Site

    Atlanta, Georgia, 30322

  • Regeneron Study Site

    Austin, Texas, 78705

  • Regeneron Study Site

    Bakersfield, California, 93309

  • Regeneron Study Site

    Bay City, Michigan, 48706

  • Regeneron Study Site

    Bellaire, Texas, 77401-3505

  • Regeneron Study Site

    Berlin, New Jersey, 08009

  • Regeneron Study Site

    Bethlehem, Pennsylvania, 18020

  • Regeneron Study Site

    Birmingham, Alabama, 35205

  • Regeneron Study Site 1

    Birmingham, Alabama, 35209

  • Regeneron Study Site 2

    Birmingham, Alabama, 35233

  • Regeneron Study Site

    Boca Raton, Florida, 33486

  • Regeneron Study Site

    Boston, Massachusetts, 02111

  • Regeneron Study Site

    Boston, Massachusetts, 02114

  • Regeneron Study Site

    Boston, Massachusetts, 02115

  • Regeneron Study Site

    Buffalo, New York, 14203

  • Regeneron Study Site

    Centennial, Colorado, 80112

  • Regeneron Study Site

    Chapel Hill, North Carolina, 27516

  • Regeneron Study Site

    Charleston, South Carolina, 29407

  • Regeneron Study Site

    Chattanooga, Tennessee, 37421

  • Regeneron Study Site

    Chicago, Illinois, 60611

  • Regeneron Study Site

    Cincinnati, Ohio, 45231

  • Regeneron Study Site

    Clearwater, Florida, 33756

  • Regeneron Study Site

    Cleveland, Ohio, 44106

  • Regeneron Study Site

    Clovis, California, 93612

  • Regeneron Study Site

    Columbus, Georgia, 31904

  • Regeneron Study Site

    Corning, New York, 14830

  • Regeneron Study Site

    Costa Mesa, California, 92626

  • Regeneron Study Site

    Dallas, Texas, 75230

  • Regeneron Study Site

    Dallas, Texas, 75231

  • Regeneron Study Site

    Dallas, Texas, 75246

  • Regeneron Study Site

    Denver, Colorado, 80206

  • Regeneron Study Site

    Denver, Colorado, 80220

  • Regeneron Study Site

    East Windsor, New Jersey, 08520

  • Regeneron Study Site

    Edina, Minnesota, 55435

  • Regeneron Study Site

    Encinitas, California, 92024

  • Regeneron Study Site

    Farmington Hills, Michigan, 48334

  • Regeneron Study Site

    Forest Hills, New York, 11375

  • Regeneron Study Site

    Fort Lauderdale, Florida, 33306

  • Regeneron Study Site

    Fort Smith, Arkansas, 72916

  • Regeneron Study Site

    Fremont, California, 94538

  • Regeneron Study Site

    Fridley, Minnesota, 55432

  • Regeneron Study Site

    Greer, South Carolina, 29650

  • Regeneron Study Site

    Henderson, Nevada, 89052

  • Regeneron Study Site

    High Point, North Carolina, 27262

  • Regeneron Study Site

    Houston, Texas, 77004

  • Regeneron Study Site

    Indianapolis, Indiana, 46250

  • Regeneron Study Site 1

    Jacksonville, Florida, 32216

  • Regeneron Study Site 2

    Jacksonville, Florida, 32216

  • Regeneron Study Site

    Jenkintown, Pennsylvania, 19046

  • Regeneron Study Site

    Lake Worth, Florida, 33461

  • Regeneron Study Site

    Las Vegas, Nevada, 89119

  • Regeneron Study Site

    Lomita, California, 90717

  • Regeneron Study Site

    Long Beach, California, 90808

  • Regeneron Study Site 1

    Los Angeles, California, 90025

  • Regeneron Study Site 2

    Los Angeles, California, 90025

  • Regeneron Study Site

    Los Angeles, California, 90045

  • Regeneron Study Site

    Macon, Georgia, 31217

  • Regeneron Study Site

    Medford, Oregon, 97504-9741

  • Regeneron Study Site

    Miami, Florida, 33135

  • Regeneron Study Site

    Miami, Florida, 33144

  • Regeneron Study Site

    Miami Lakes, Florida, 33016

  • Regeneron Study Site

    Minneapolis, Minnesota, 55402

  • Regeneron Study Site

    Nashville, Tennessee, 37215

  • Regeneron Study Site

    New Orleans, Louisiana, 70112

  • Regeneron Study Site

    New York, New York, 10016

  • Regeneron Study Site

    New York, New York, 10021

  • Regeneron Study Site

    New York, New York, 10029-6501

  • Regeneron Study Site

    New York, New York, 10075

  • Regeneron Study Site

    Newburgh, Indiana, 47630

  • Regeneron Study Site

    Newnan, Georgia, 30263

  • Regeneron Study Site

    Newport News, Virginia, 23606-4537

  • Regeneron Study Site

    Norfolk, Virginia, 23502

  • Regeneron Study Site

    Normal, Illinois, 61761

  • Regeneron Study Site

    Norman, Oklahoma, 73071

  • Regeneron Study Site

    Oceanside, California, 92056

  • Regeneron Study Site

    Orange, California, 92868

  • Regeneron Study Site

    Orlando, Florida, 32806

  • Regeneron Study Site

    Overland Park, Kansas, 66215

  • Regeneron Study Site

    Philadelphia, Pennsylvania, 19104

  • Regeneron Study Site 2

    Phoenix, Arizona, 85018

  • Regeneron Study Site 3

    Phoenix, Arizona, 85023

  • Regeneron Study Site 1

    Phoenix, Arizona, 85032

  • Regeneron Study Site

    Pittsburgh, Pennsylvania, 15213

  • Regeneron Study Site

    Plainfield, Indiana, 46168

  • Regeneron Study Site

    Plymouth, Minnesota, 55402

  • Regeneron Study Site

    Portland, Oregon, 97223

  • Regeneron Study Site

    Portland, Oregon, 97239

  • Regeneron Study Site

    Portsmouth, New Hampshire, 03801

  • Regeneron Study Site

    Raleigh, North Carolina, 27612

  • Regeneron Study Site

    Richmond, Virginia, 23220

  • Regeneron Study Site

    Rochester, New York, 14642

  • Regeneron Study Site

    Rockville, Maryland, 20850

  • Regeneron Study Site

    Rogers, Arkansas, 72758

  • Regeneron Study Site

    Rolling Hills Estates, California, 90274

  • Regeneron Study Site

    Saint Joseph, Missouri, 64506

  • Regeneron Study Site

    Salt Lake City, Utah, 84132

  • Regeneron Study Site

    San Antonio, Texas, 78218

  • Regeneron Study Site 1

    San Antonio, Texas, 78229

  • Regeneron Study Site 2

    San Antonio, Texas, 78229

  • Regeneron Study Site

    San Antonio, Texas, 78258

  • Regeneron Study Site

    San Diego, California, 92122

  • Regeneron Study Site 1

    San Diego, California, 92123

  • Regeneron Study Site 2

    San Diego, California, 92123

  • Regeneron Study Site

    Sandy Springs, Georgia, 30328

  • Regeneron Study Site

    Santa Monica, California, 90404

  • Regeneron Study Site

    Savannah, Georgia, 31405

  • Regeneron Study Site

    Seattle, Washington, 98101

  • Regeneron Study Site

    South Burlington, Vermont, 05403

  • Regeneron Study Site

    St Louis, Missouri, 63104

  • Regeneron Study Site

    St Louis, Missouri, 63141

  • Regeneron Study Site

    Tampa, Florida, 33607

  • Regeneron Study Site

    Tampa, Florida, 33614

  • Regeneron Study Site

    Tampa, Florida, 33624

  • Regeneron Study Site

    Troy, Michigan, 48084

  • Regeneron Study Site

    Trumbull, Connecticut, 06611

  • Regeneron Study Site

    Tulsa, Oklahoma, 74136

  • Regeneron Study Site

    Verona, New Jersey, 07044-2946

  • Regeneron Study Site

    Waco, Texas, 76710

  • Regeneron Study Site

    Washington D.C., District of Columbia, 20037

  • Regeneron Study Site

    Webster, Texas, 77598

  • Regeneron Study Site

    West Dundee, Illinois, 60118

  • Regeneron Study Site

    West Palm Beach, Florida, 33406

  • Regeneron Study Site

    Wilmington, North Carolina, 28405

  • Regeneron Study Site

    Winston-Salem, North Carolina, 27104

Other trials in United States

Japan59 sites

  • Regeneron Study Site 1

    Amagasaki, Hyôgo

  • Regeneron Study Site 2

    Amagasaki, Hyôgo

  • Regeneron Study Site 1

    Bunkyo-ku, Tokyo

  • Regeneron Study Site 2

    Bunkyo-ku, Tokyo

  • Regeneron Study Site 1

    Chiyoda-ku, Tokyo

  • Regeneron Study Site 2

    Chiyoda-ku, Tokyo

  • Regeneron Study Site

    Chūō, Yamanashi

  • Regeneron Study Site

    Chuo-ku, Tokyo

  • Regeneron Study Site 1

    Fukuoka, Hukuoka

  • Regeneron Study Site 2

    Fukuoka, Hukuoka

  • Regeneron Study Site

    Fukuyama, Hiroshima

  • Regeneron Study Site 2

    Fukuyama

  • Regeneron Study Site

    Gifu

  • Regeneron Study Site

    Habikino, Osaka

  • Regeneron Study Site

    Hamamatsu, Shizuoka

  • Regeneron Study Site 1

    Hiroshima

  • Regeneron Study Site 2

    Hiroshima

  • Regeneron Study Site

    Inashiki-gun, Ibaraki

  • Regeneron Study Site

    Kamimashiki, Kumamoto

  • Regeneron Study Site

    Kitakyushu, Hukuoka

  • Regeneron Study Site

    Kofu, Yamanashi

  • Regeneron Study Site

    Koto-ku, Tokyo

  • Regeneron Study Site

    Kurume, Fukuoka

  • Regeneron Study Site 1

    Kyoto

  • Regeneron Study Site 2

    Kyoto

  • Regeneron Study Site

    Nagakute, Aichi-ken

  • Regeneron Study Site

    Nakano-ku, Tokyo

  • Regeneron Study Site 1

    Nerima City, Tokyo

  • Regeneron Study Site 2

    Nerima City, Tokyo

  • Regeneron Study Site

    Neyagawa, Osaka

  • Regeneron Study Site 1

    Osaka

  • Regeneron Study Site 2

    Osaka

  • Regeneron Study Site

    Ōta-ku, Tokyo

  • Regeneron Study Site

    Saitama

  • Regeneron Study Site

    Sakai, Osaka

  • Regeneron Study Site

    Sapporo, Hokkaido

  • Regeneron Study Site

    Setagaya-ku, Tokyo

  • Regeneron Study Site 1

    Shibuya-ku, Tokyo

  • Regeneron Study Site 2

    Shibuya-ku, Tokyo

  • Regeneron Study Site 3

    Shibuya-ku, Tokyo

  • Regeneron Study Site 1

    Shinagawa-ku, Tokyo

  • Regeneron Study Site 2

    Shinagawa-ku, Tokyo

  • Regeneron Study Site 3

    Shinagawa-ku

  • Regeneron Study Site 1

    Shinjuku-ku, Tokyo

  • Regeneron Study Site 2

    Shinjuku-ku, Tokyo

  • Regeneron Study Site 3

    Shinjuku-ku, Tokyo

  • Regeneron Study Site 4

    Shinjuku-ku, Tokyo

  • Regeneron Study Site 5

    Shinjuku-ku, Tokyo

  • Regeneron Study Site 6

    Shinjuku-ku, Tokyo

  • Regeneron Study Site 1

    Suginami, Tokyo

  • Regeneron Study Site 2

    Suginami, Tokyo

  • Regeneron Study Site

    Suginome

  • Regeneron Study Site

    Takatsuki, Osaka

  • Regeneron Study Site

    Wakayama

  • Regeneron Study Site

    Yaizu, Shizuoka

  • Regeneron Study Site 1

    Yokohama, Kanagawa

  • Regeneron Study Site 2

    Yokohama, Kanagawa

  • Regeneron Study Site 3

    Yokohama, Kanagawa

  • Regeneron Study Site 4

    Yokohama

Other trials in Japan

Germany44 sites

  • Regeneron Study Site

    Augsburg, Bavaria

  • Regeneron Study Site 1

    Berlin

  • Regeneron Study Site 2

    Berlin

  • Regeneron Study Site 3

    Berlin

  • Regeneron Study Site 4

    Berlin

  • Regeneron Study Site 5

    Berlin

  • Regeneron Study Site 6

    Berlin

  • Regeneron Study Site 7

    Berlin

  • Regeneron Study Site 1

    Bochum, North Rhine-Westphalia

  • Regeneron Study Site 2

    Bochum, North Rhine-Westphalia

  • Regeneron Study Site

    Bonn

  • Regeneron Study Site

    Darmstadt

  • Regeneron Study Site 1

    Dresden, Saxony

  • Regeneron Study Site 2

    Dresden, Saxony

  • Regeneron Study Site 3

    Dresden, Saxony

  • Regeneron Study Site

    Dülmen, North Rhine-Westphalia

  • Regeneron Study Site

    Erlangen, Bavaria

  • Regeneron Study Site

    Frankfurt am Main, Hesse

  • Regeneron Study Site

    Friedrichshafen, Baden-Wurttemberg

  • Regeneron Study Site

    Gera, Thuringia

  • Regeneron Study Site

    Halle, Saxony-Anhalt

  • Regeneron Study Site 2

    Hamburg, Free and Hanseatic City of Hamburg

  • Regeneron Study Site 1

    Hamburg

  • Regeneron Study Site

    Hanover, Lower Saxony

  • Regeneron Study Site

    Heidelberg, Baden-Wurttemberg

  • Regeneron Study Site

    Ibbenbueren, North Rhine-Westphalia

  • Regeneron Study Site 1

    Kiel, Schleswig-Holstein

  • Regeneron Study Site 2

    Kiel, Schleswig-Holstein

  • Regeneron Study Site

    Langenau, Baden-Wurttemberg

  • Regeneron Study Site

    Leipzig, Saxony

  • Regeneron Study Site

    Lübeck, Schleswig-Holstein

  • Regeneron Study Site

    Magdeburg, Saxony-Anhalt

  • Regeneron Study Site

    Mahlow, Brandenburg

  • Regeneron Study Site

    Mainz, Rhineland-Palatinate

  • Regeneron Study Site

    Mönchengladbach, North Rhine-Westphalia

  • Regeneron Study Site

    München, Bavaria

  • Regeneron Study Site

    Munich, Bavaria

  • Regeneron Study Site

    Münster, North Rhine-Westphalia

  • Regeneron Study Site

    Münster

  • Regeneron Study Site

    Osnabrück

  • Regeneron Study Site

    Schwerin, Mecklenburg-Vorpommern

  • Regeneron Study Site

    Selters, Rhineland-Palatinate

  • Regeneron Study Site

    Stuttgart, Baden-Wurttemberg

  • Regeneron Study Site

    Tübingen, Baden-Wurttemberg

Other trials in Germany

Canada36 sites

  • Regeneron Study Site

    Ajax, Ontario

  • Regeneron Study Site 1

    Barrie, Ontario

  • Regeneron Study Site 2

    Barrie, Ontario

  • Regeneron Study Site

    Bathurst, New Brunswick

  • Regeneron Study Site 1

    Calgary, Alberta

  • Regeneron Study Site 2

    Calgary, Alberta

  • Regeneron Study Site

    Drummondville, Quebec

  • Regeneron Study Site 1

    Edmonton, Alberta

  • Regeneron Study Site 2

    Edmonton, Alberta

  • Regeneron Study Site

    Etobicoke, Ontario

  • Regeneron Study Site 1

    Hamilton, Ontario

  • Regeneron Study Site 2

    Hamilton, Ontario

  • Regeneron Study Site

    Markham, Ontario

  • Regeneron Study Site

    Mississauga, Ontario

  • Regeneron Study Site

    Montreal, Quebec

  • Regeneron Study Site

    Newmarket, Ontario

  • Regeneron Study Site

    North Bay, Ontario

  • Regeneron Study Site

    Oakville, Ontario

  • Regeneron Study Site 1

    Ottawa, Ontario

  • Regeneron Study Site

    Peterborough, Ontario

  • Regeneron Study Site 1

    Richmond Hill, Ontario

  • Regeneron Study Site 2

    Richmond Hill, Ontario

  • Regeneron Study Site

    St. John's, Newfoundland and Labrador

  • Regeneron Study Site 3

    Ste-Foy, Quebec

  • Regeneron Study Site

    Ste-Foy

  • Regeneron Study Site 1

    Surrey, British Columbia

  • Regeneron Study Site 2

    Surrey, British Columbia

  • Regeneron Study Site

    Toronto, Ontario

  • Regeneron Study Site 1

    Vancouver, British Columbia

  • Regeneron Study Site 2

    Vancouver, British Columbia

  • Regeneron Study Site 3

    Vancouver, British Columbia

  • Regeneron Study Site

    Waterloo, Ontario

  • Regeneron Study Site 1

    Windsor, Ontario

  • Regeneron Study Site 2

    Windsor, Ontario

  • Regeneron Study Site 1

    Winnipeg, Manitoba

  • Regeneron Study Site

    Winnipeg

Other trials in Canada

Poland36 sites

  • Regeneron Study Site

    Bialystok

  • Regeneron Study Site

    Bydgoszcz

  • Regeneron Study Site

    Chorzów

  • Regeneron Study Site

    Elblag, 82300

  • Regeneron Study Site 1

    Gdansk, Pomeranian Voivodeship

  • Regeneron Study Site 2

    Gdansk, Pomeranian Voivodeship

  • Regeneron Study Site

    Iwonicz-Zdrój, Podkarpackie Voivodeship

  • Regeneron Study Site 1

    Katowice

  • Regeneron Study Site 2

    Katowice

  • Regeneron Study Site 3

    Katowice

  • Regeneron Study Site 1

    Krakow, Lesser Poland Voivodeship

  • Regeneron Study Site 2

    Krakow, Lesser Poland Voivodeship

  • Regeneron Study Site 3

    Krakow, Lesser Poland Voivodeship

  • Regeneron Study Site 1

    Lodz, Łódź Voivodeship

  • Regeneron Study Site 2

    Lodz, Łódź Voivodeship

  • Regeneron Study Site 3

    Lodz, Łódź Voivodeship

  • Regeneron Study Site

    Lublin, Lublin Voivodeship

  • Regeneron Study Site

    Ostrowiec Świętokrzyski

  • Regeneron Study Site 1

    Poznan, Greater Poland Voivodeship

  • Regeneron Study Site 2

    Poznan, Greater Poland Voivodeship

  • Regeneron Study Site 3

    Poznan, Greater Poland Voivodeship

  • Regeneron Study Site

    Skarżysko-Kamienna

  • Regeneron Study Site

    Strzelce Opolskie, Opole Voivodeship

  • Regeneron Study Site

    Szczecin, West Pomeranian Voivodeship

  • Regeneron Study Site

    Torun, Kuyavian-Pomeranian Voivodeship

  • Regeneron Study Site 1

    Warsaw, Masovian Voivodeship

  • Regeneron Study Site 2

    Warsaw, Masovian Voivodeship

  • Regeneron Study Site 3

    Warsaw, Masovian Voivodeship

  • Regeneron Study Site 4

    Warsaw, Masovian Voivodeship

  • Regeneron Study Site 5

    Warsaw, Masovian Voivodeship

  • Regeneron Study Site 6

    Warsaw, Masovian Voivodeship

  • Regeneron Study Site 7

    Warsaw, Masovian Voivodeship

  • Regeneron Study Site 1

    Wroclaw, Lower Silesian Voivodeship

  • Regeneron Study Site 2

    Wroclaw, Lower Silesian Voivodeship

  • Regeneron Study Site 3

    Wroclaw, Lower Silesian Voivodeship

  • Regeneron Study Site

    Zgierz, 95100

Other trials in Poland

South Korea15 sites

  • Regeneron Study Site

    Bucheon-si, Kyonggi-do

  • Regeneron Study Site

    Busan, Busan Gwang'yeogsi

  • Regeneron Study Site

    Hwaseong-si, Kyonggi-do

  • Regeneron Study Site 1

    Incheon

  • Regeneron Study Site 2

    Incheon

  • Regeneron Study Site 1

    Seoul

  • Regeneron Study Site 2

    Seoul

  • Regeneron Study Site 3

    Seoul

  • Regeneron Study Site 4

    Seoul

  • Regeneron Study Site 5

    Seoul

  • Regeneron Study Site 6

    Seoul

  • Regeneron Study Site 7

    Seoul

  • Regeneron Study Site 8

    Seoul

  • Regeneron Study Site

    Suwon, Kyonggi-do

  • Regeneron Study Site

    Uijeongbu-si, Kyonggi-do

Other trials in South Korea

Italy14 sites

  • Regeneron Study Site

    Ancona

  • Regeneron Study Site

    Bologna, Balogna

  • Regeneron Study Site

    Chieti

  • Regeneron Study Site

    Florence

  • Regeneron Study Site

    L’Aquila

  • Regeneron Study Site

    Lucca

  • Regeneron Study Site

    Messina

  • Regeneron Study Site

    Milan

  • Regeneron Study Site

    Novara

  • Regeneron Study Site

    Pavia

  • Regeneron Study Site

    Perugia

  • Regeneron Study Site

    Pisa

  • Regeneron Study Site 1

    Roma

  • Regeneron Study Site 2

    Roma

Other trials in Italy

United Kingdom13 sites

  • Regeneron Study Site

    Dundee, Angus

  • Regeneron Study Site

    Edgbaston, Birmingham

  • Regeneron Study Site

    Liverpool

  • Regeneron Study Site 1

    London

  • Regeneron Study Site 2

    London

  • Regeneron Study Site

    Manchester

  • Regeneron Study Site

    Northwood, London

  • Regeneron Study Site

    Oxford, Oxfordshire

  • Regeneron Study Site

    Plymouth, Devon

  • Regeneron Study Site

    Portsmouth, Hampshire

  • Regeneron Study Site

    Salford

  • Regeneron Study Site

    Sheffield

  • Regeneron Study Site

    Sidcup, Kent

Other trials in United Kingdom

Spain10 sites

  • Regeneron Study Site

    Badalona, Barcelona

  • Regeneron Study Site 1

    Barcelona

  • Regeneron Study Site 2

    Barcelona

  • Regeneron Study Site 3

    Barcelona

  • Regeneron Study Site 4

    Barcelona

  • Regeneron Study Site

    Elche, Alicante

  • Regeneron Study Site

    Las Palmas de Gran Canaria, Canary Islands

  • Regeneron Study Site 1

    Madrid

  • Regeneron Study Site 2

    Madrid

  • Regeneron Study Site

    Seville

Other trials in Spain

Hungary9 sites

  • Regeneron Study Site 1

    Budapest

  • Regeneron Study Site 2

    Budapest

  • Regeneron Study Site 3

    Budapest

  • Regeneron Study Site

    Kaposvár, Somogy County

  • Regeneron Study Site

    Orosháza, Bekes County

  • Regeneron Study Site

    Sátoraljaújhely, Borsod-Abauj Zemplen county

  • Regeneron Study Site

    Szeged, Csongrád megye

  • Regeneron Study Site

    Szolnok, Jász-Nagykun-Szolnok

  • Regeneron Study Site

    Veszprém

Other trials in Hungary

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About this study

Official title: An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials

The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD).

The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.

Read more

Optional Sub-Study:

The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product.

The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

Being tested
Dupilumab
Medical subject headings
Dermatitis, Atopic

What participants receive

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

  • DupilumabDrug

    Also called DUPIXENT®, REGN668, SAR231893

Study groups in NCT01949311
Study groupRoleWhat they receive
DupilumabExperimentalParticipants will receive repeat doses of dupilumab
Receives: Drug: Dupilumab

What is being measured

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

  1. Number of Treatment Emergent Adverse Events (TEAEs)

    Measured: Up to 272 weeks

  2. OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product

    Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)

    Measured: Up to 24 Weeks

Secondary outcomes (22)

  1. Number of Serious Adverse Events (SAEs) of Special Interest

    Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)

    Measured: Up to 272 weeks

  2. Rate of AESIs

    Rate (events per patient-year) of AESIs

    Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)

    Measured: Up to 272 weeks

  3. Number of AESIs

    Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)

    Measured: Up to 272 weeks

  4. Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit

    IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration.

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)

  5. Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"

  6. Percentage of Participants With Low Disease Activity State (eg, IGA ≤2) at Each Visit

    Low disease activity state is defined as an IGA score of ≤2 [mild = 2, almost clear = 1, or clear = 0]

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"

  7. Change From Baseline in EASI Score at Each Visit

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"

  8. Percent Change From Baseline in EASI Score at Each Visit

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"

  9. Percentage of Participants With EASI-50 (≥50% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit

    EASI-50 was defined as >=50% reduction in EASI scores from baseline of the parent study

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"

  10. Percentage of Participants With EASI-90 (≥90% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit

    EASI-90 was defined as >=90% reduction in EASI scores from baseline of the parent study

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"

  11. Change From Baseline in Pruritus Numerical Rating Scale (NRS) in Parent Study

    The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable.

    Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score.

    Weekly worst score is calculated by taking the worst score within the week

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)"

  12. Percent Change From Baseline in Pruritus NRS

    The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable.

    Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score.

    Weekly worst score is calculated by taking the worst score within the week

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)"

  13. Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥3 From Baseline

    The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable.

    Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score.

    Weekly worst score is calculated by taking the worst score within the week

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)"

  14. Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥4 From Baseline

    The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable.

    Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score.

    Weekly worst score is calculated by taking the worst score within the week

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)"

  15. Percentage of Participants Requiring Rescue Treatment: Overall

    Measured: Up to 272 weeks

  16. Percentage of Participants Requiring Rescue Treatment: Systemic Treatment

    Measured: Up to 272 weeks

  17. Percentage of Participants Requiring Rescue Treatment: Phototherapy

    Measured: Up to 272 weeks

  18. Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Dermatology Life Quality Index (DLQI)

    The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The format is a simple response to 10 items, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"

  19. Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Patient Oriented Eczema Measure (POEM)

    The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults. The format is a response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) with a scoring system of 0 to 28; a high score is indicative of a poor QOL.

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"

  20. Changes From Parent Study Baseline to Prespecified Time Points Through the End of the Study: EuroQol-5D (EQ-5D)

    The EuroQOL 5-Dimension Health Questionnaire (EQ-5D) is a standardized measure of health status developed by the EuroQOL Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The minimum value for the single index utility score is -0.594 (Best imaginable health state) and the maximum value for the single index utility score is 1 (Worst imaginable health state).

    Measured: Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"

  21. OPTIONAL SUB-STUDY: Ctrough of Functional Dupilumab in Serum Before and After Switching to the New Dupilumab Drug Product

    Measured: Up to week 12

  22. OPTIONAL SUB-STUDY: Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response in Patients Receiving the New Dupilumab Drug Product

    For participants receiving dupilumab from a new manufacturing process, ADA baseline was defined as the baseline visit in the sub-study, or at the end of the main study, dependent on available data.

    Measured: Up to 24 Weeks

Timeline

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

  1. First posted24 Sep 2013 (estimated)
  2. Study start10 Oct 2013
  3. Primary completion27 Jun 2022
  4. Study completion27 Jun 2022

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
2,733 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01949311
Sponsor's protocol ID
R668-AD-1225
Other IDs
2013-001449-15
Status last verified
Oct 2023
First submitted
20 Sep 2013
Last updated
17 Oct 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Beck LA, Simpson EL, Thaci D, de Bruin-Weller M, Deleuran M, Kataoka Y, Blauvelt A, Wollenberg A, Eichenfield LF, Khokhar FA, Coleman A, Van Spall M, Ma Y, Avetisova E, Zhang A, Nguyen TV. Long-Term Dupilumab Treatment Is Not Associated with an Increased Overall Risk of Infections in Adults with Moderate-to-Severe Atopic Dermatitis: Results from an Open-Label 5-Year Extension Study. Adv Ther. 2026 Jul;43(7):2930-2948. doi: 10.1007/s12325-026-03582-8. Epub 2026 Apr 18.

    PubMed 41999446

  • Simpson EL, Bissonnette R, Deleuran M, Nakahara T, Galus R, de Bruin-Weller M, Coleman A, van Spall M, Chen Z, Avetisova E, Bastian M, Khokhar FA. Dupilumab Treatment Up to 5 Years Shows No Clinically Meaningful Changes in Laboratory Parameters in Adults with Moderate-to-Severe Atopic Dermatitis. Adv Ther. 2026 Mar;43(3):1213-1238. doi: 10.1007/s12325-025-03458-3. Epub 2026 Jan 21.

    PubMed 41563707

  • Kamal MA, Kosloski MP, Lai CH, Partridge MA, Rajadhyaksha M, Kanamaluru V, Bansal A, Shabbir A, Shumel B, Ardeleanu M, Richards SM, Yan H, Xu CR, Rodriguez-Marco A, Xiao J, Khokhar FA, Gherardi G, Babilonia E, Maloney J, Mortensen E, Akinlade B, Braunstein N, Stahl N, Torri A, Davis JD, DiCioccio AT. Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatitis. Front Immunol. 2024 Nov 11;15:1466372. doi: 10.3389/fimmu.2024.1466372. eCollection 2024.

    PubMed 39588375

  • Blauvelt A, Wollenberg A, Eichenfield LF, Zhang H, Sierka D, Khokhar FA, Vakil J, Shabbir A, Marco AR, Cyr SL. No Increased Risk of Overall Infection in Adults with Moderate-to-Severe Atopic Dermatitis Treated for up to 4 Years with Dupilumab. Adv Ther. 2023 Jan;40(1):367-380. doi: 10.1007/s12325-022-02322-y. Epub 2022 Nov 1.

    PubMed 36318387

  • Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.

    PubMed 35636689

  • Beck LA, Deleuran M, Bissonnette R, de Bruin-Weller M, Galus R, Nakahara T, Seo SJ, Khokhar FA, Vakil J, Xiao J, Marco AR, Levit NA, O'Malley JT, Shabbir A. Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2022 May;23(3):393-408. doi: 10.1007/s40257-022-00685-0. Epub 2022 May 3.

    PubMed 35503163

  • Armstrong A, Blauvelt A, Simpson EL, Smith CH, Herranz P, Kataoka Y, Seo SJ, Ferrucci SM, Chao J, Chen Z, Rossi AB, Shumel B, Tomondy P. Continued Treatment with Dupilumab is Associated with Improved Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Not Achieving Optimal Responses with Short-Term Treatment. Dermatol Ther (Heidelb). 2022 Jan;12(1):195-202. doi: 10.1007/s13555-021-00643-4. Epub 2021 Dec 13.

    PubMed 34897582

  • Yosipovitch G, de Bruin-Weller M, Armstrong A, Wu JJ, Herranz P, Thaci D, Delevry D, Bagousse GB, Zhang R, Shumel B, Rossi AB, Chao J. Dupilumab Treatment Provides Sustained Improvements Over 2 Years in Symptoms and Quality of Life in Adults with Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Dec;11(6):2147-2157. doi: 10.1007/s13555-021-00630-9. Epub 2021 Oct 29.

    PubMed 34714527

  • Beck LA, Thaci D, Deleuran M, de Bruin-Weller M, Chen Z, Khokhar FA, Zhang M, Ozturk ZE, Shumel B. Laboratory safety of dupilumab for up to 3 years in adults with moderate-to-severe atopic dermatitis: results from an open-label extension study. J Dermatolog Treat. 2022 May;33(3):1608-1616. doi: 10.1080/09546634.2020.1871463. Epub 2021 Feb 8.

    PubMed 33557637

  • Beck LA, Thaci D, Deleuran M, Blauvelt A, Bissonnette R, de Bruin-Weller M, Hide M, Sher L, Hussain I, Chen Z, Khokhar FA, Beazley B, Ruddy M, Patel N, Graham NMH, Ardeleanu M, Shumel B. Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2020 Aug;21(4):567-577. doi: 10.1007/s40257-020-00527-x.

    PubMed 32557382

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab in people with Atopic Dermatitis, run by Regeneron Pharmaceuticals at 432 sites in 28 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 11 inclusion and 9 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 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 432 sites in United States, Japan, Germany, Canada, Poland and 23 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 17 Oct 2023). 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 Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 272 weeks). The study lists 2 primary outcomes in all. 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 NCT01949311, which also lists 10 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 17 Oct 2023.

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