Open-label Study of Dupilumab in Patients With Atopic Dermatitis

October 16, 2023 updated by: Regeneron Pharmaceuticals

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.

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.

Study Overview

Status

Completed

Conditions

Atopic Dermatitis

Intervention / Treatment

Drug: Dupilumab

Study Type

Interventional

Enrollment (Actual)

2733

Phase

Phase 3

Contacts and Locations

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

Study Locations

Australia
- Australian Capital Territory
  - Phillip, Australian Capital Territory, Australia
    - Regeneron Study Site
- New South Wales
  - Kogarah, New South Wales, Australia
    - Regeneron Study Site
- Queensland
  - Benowa, Queensland, Australia
    - Regeneron Study Site
  - Woolloongabba, Queensland, Australia
    - Regeneron Study Site
- South Australia
  - Hectorville, South Australia, Australia
    - Regeneron Study Site
- Victoria
  - Carlton, Victoria, Australia
    - Regeneron Study Site
  - East Melbourne, Victoria, Australia
    - Regeneron Study Site
- Western Australia
  - Fremantle, Western Australia, Australia
    - Regeneron Study Site
Austria
- - Wien, Austria
    - Regeneron Study Site 1
  - Wien, Austria
    - Regeneron Study Site 2
Belgium
- Brussels Capital Region
  - Bruxelles, Brussels Capital Region, Belgium
    - Regeneron Study Site
- Hainaut
  - Loverval, Hainaut, Belgium
    - Regeneron Study Site
- Vlaams Brabant
  - Leuven, Vlaams Brabant, Belgium
    - Regeneron Study Site
Bulgaria
- Kjustendil
  - Dupnitsa, Kjustendil, Bulgaria
    - Regeneron Study Site
- Sofia-Grad
  - Sofia, Sofia-Grad, Bulgaria
    - Regeneron Study Site 1
  - Sofia, Sofia-Grad, Bulgaria
    - Regeneron Study Site 2
Canada
- - Ste-Foy, Canada
    - Regeneron Study Site
  - Winnipeg, Canada
    - Regeneron Study Site
- Alberta
  - Calgary, Alberta, Canada
    - Regeneron Study Site 1
  - Calgary, Alberta, Canada
    - Regeneron Study Site 2
  - Edmonton, Alberta, Canada
    - Regeneron Study Site 1
  - Edmonton, Alberta, Canada
    - Regeneron Study Site 2
- British Columbia
  - Surrey, British Columbia, Canada
    - Regeneron Study Site 1
  - Surrey, British Columbia, Canada
    - Regeneron Study Site 2
  - Vancouver, British Columbia, Canada
    - Regeneron Study Site 1
  - Vancouver, British Columbia, Canada
    - Regeneron Study Site 2
  - Vancouver, British Columbia, Canada
    - Regeneron Study Site 3
- Manitoba
  - Winnipeg, Manitoba, Canada
    - Regeneron Study Site 1
- New Brunswick
  - Bathurst, New Brunswick, Canada
    - Regeneron Study Site
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada
    - Regeneron Study Site
- Ontario
  - Ajax, Ontario, Canada
    - Regeneron Study Site
  - Barrie, Ontario, Canada
    - Regeneron Study Site 1
  - Barrie, Ontario, Canada
    - Regeneron Study Site 2
  - Etobicoke, Ontario, Canada
    - Regeneron Study Site
  - Hamilton, Ontario, Canada
    - Regeneron Study Site 1
  - Hamilton, Ontario, Canada
    - Regeneron Study Site 2
  - Markham, Ontario, Canada
    - Regeneron Study Site
  - Mississauga, Ontario, Canada
    - Regeneron Study Site
  - Newmarket, Ontario, Canada
    - Regeneron Study Site
  - North Bay, Ontario, Canada
    - Regeneron Study Site
  - Oakville, Ontario, Canada
    - Regeneron Study Site
  - Ottawa, Ontario, Canada
    - Regeneron Study Site 1
  - Peterborough, Ontario, Canada
    - Regeneron Study Site
  - Richmond Hill, Ontario, Canada
    - Regeneron Study Site 1
  - Richmond Hill, Ontario, Canada
    - Regeneron Study Site 2
  - Toronto, Ontario, Canada
    - Regeneron Study Site
  - Waterloo, Ontario, Canada
    - Regeneron Study Site
  - Windsor, Ontario, Canada
    - Regeneron Study Site 1
  - Windsor, Ontario, Canada
    - Regeneron Study Site 2
- Quebec
  - Drummondville, Quebec, Canada
    - Regeneron Study Site
  - Montreal, Quebec, Canada
    - Regeneron Study Site
  - Ste-Foy, Quebec, Canada
    - Regeneron Study Site 3
China
- - Hong Kong, China
    - Regeneron Study Site
Czechia
- - Hradec Kralove, Czechia
    - Regeneron Study Site
  - Kutna Hora, Czechia
    - Regeneron Study Site
  - Nachod, Czechia
    - Regeneron Study Site
  - Praha 10, Czechia
    - Regeneron Study Site
  - Praha 5, Czechia
    - Regeneron Study Site
  - Praha 6, Czechia
    - Regeneron Study Site
  - Svitavy, Czechia
    - Regeneron Study Site
  - Usti nad Labem, Czechia
    - Regeneron Study Site
Denmark
- Capital
  - Copenhagen, Capital, Denmark
    - Regeneron Study Site
  - Hellerup, Capital, Denmark
    - Regeneron Study Site
- Central Jutland
  - Aarhus, Central Jutland, Denmark
    - Regeneron Study Site
- Zeeland
  - Roskilde, Zeeland, Denmark
    - Regeneron Study Site
Estonia
- Harjumaa
  - Tallinn, Harjumaa, Estonia
    - Regeneron Study Site 1
  - Tallinn, Harjumaa, Estonia
    - Regeneron Study Site 2
  - Tallinn, Harjumaa, Estonia
    - Regeneron Study Site 3
- Tartumaa
  - Tartu, Tartumaa, Estonia
    - Regeneron Study Site 1
  - Tartu, Tartumaa, Estonia
    - Regeneron Study Site 2
Finland
- Etelä-Suomen Iääni
  - Helsinki, Etelä-Suomen Iääni, Finland
    - Regeneron Study Site
- Etelä-Suomen Lääni
  - Turku, Etelä-Suomen Lääni, Finland
    - Regeneron Study Site
- Länsi-Suomen Lääni
  - Tampere, Länsi-Suomen Lääni, Finland
    - Regeneron Study Site
France
- - Lille cedex, France
    - Regeneron Study Site
  - Nantes, France
    - Regeneron Study Site
- Alpes-Maritimes
  - Nice Cedex 3, Alpes-Maritimes, France
    - Regeneron Study Site
- Bouches-du-Rhône
  - Marseille, Bouches-du-Rhône, France
    - Regeneron Study Site
- Marne
  - Reims, Marne, France
    - Regeneron Study Site
- Nord
  - Lille, Nord, France
    - Regeneron Study Site
- Rhône-Alpes
  - Pierre Benite, Rhône-Alpes, France
    - Regeneron Study Site
- Île-de-France
  - Paris, Île-de-France, France
    - Regeneron Study Site
Germany
- - Berlin, Germany
    - Regeneron Study Site 1
  - Berlin, Germany
    - Regeneron Study Site 2
  - Berlin, Germany
    - Regeneron Study Site 3
  - Berlin, Germany
    - Regeneron Study Site 4
  - Berlin, Germany
    - Regeneron Study Site 5
  - Berlin, Germany
    - Regeneron Study Site 6
  - Berlin, Germany
    - Regeneron Study Site 7
  - Bonn, Germany
    - Regeneron Study Site
  - Darmstadt, Germany
    - Regeneron Study Site
  - Hamburg, Germany
    - Regeneron Study Site 1
  - Münster, Germany
    - Regeneron Study Site
  - Osnabrück, Germany
    - Regeneron Study Site
- Baden-Württemberg
  - Friedrichshafen, Baden-Württemberg, Germany
    - Regeneron Study Site
  - Heidelberg, Baden-Württemberg, Germany
    - Regeneron Study Site
  - Langenau, Baden-Württemberg, Germany
    - Regeneron Study Site
  - Stuttgart, Baden-Württemberg, Germany
    - Regeneron Study Site
  - Tuebingen, Baden-Württemberg, Germany
    - Regeneron Study Site
- Bayern
  - Augsburg, Bayern, Germany
    - Regeneron Study Site
  - Erlangen, Bayern, Germany
    - Regeneron Study Site
  - Munchen, Bayern, Germany
    - Regeneron Study Site
  - Munich, Bayern, Germany
    - Regeneron Study Site
- Brandenburg
  - Mahlow, Brandenburg, Germany
    - Regeneron Study Site
- Hamburgh
  - Hamburg, Hamburgh, Germany
    - Regeneron Study Site 2
- Hessen
  - Frankfurt/Main, Hessen, Germany
    - Regeneron Study Site
- Mecklenburg-Vorpommern
  - Schwerin, Mecklenburg-Vorpommern, Germany
    - Regeneron Study Site
- Niedersachsen
  - Hannover, Niedersachsen, Germany
    - Regeneron Study Site
- Nordrhein-Westfalen
  - Bochum, Nordrhein-Westfalen, Germany
    - Regeneron Study Site 1
  - Bochum, Nordrhein-Westfalen, Germany
    - Regeneron Study Site 2
  - Dulmen, Nordrhein-Westfalen, Germany
    - Regeneron Study Site
  - Ibbenbüren, Nordrhein-Westfalen, Germany
    - Regeneron Study Site
  - Monchengladbach, Nordrhein-Westfalen, Germany
    - Regeneron Study Site
  - Muenster, Nordrhein-Westfalen, Germany
    - Regeneron Study Site
- Rheinland-Pfalz
  - Mainz, Rheinland-Pfalz, Germany
    - Regeneron Study Site
  - Selters, Rheinland-Pfalz, Germany
    - Regeneron Study Site
- Sachsen
  - Dresden, Sachsen, Germany
    - Regeneron Study Site 1
  - Dresden, Sachsen, Germany
    - Regeneron Study Site 2
  - Dresden, Sachsen, Germany
    - Regeneron Study Site 3
  - Leipzig, Sachsen, Germany
    - Regeneron Study Site
- Sachsen-Anhalt
  - Halle, Sachsen-Anhalt, Germany
    - Regeneron Study Site
  - Magdeburg, Sachsen-Anhalt, Germany
    - Regeneron Study Site
- Schleswig-Holstein
  - Kiel, Schleswig-Holstein, Germany
    - Regeneron Study Site 1
  - Kiel, Schleswig-Holstein, Germany
    - Regeneron Study Site 2
  - Lubeck, Schleswig-Holstein, Germany
    - Regeneron Study Site
- Thüringen
  - Gera, Thüringen, Germany
    - Regeneron Study Site
Hungary
- - Budapest, Hungary
    - Regeneron Study Site 1
  - Budapest, Hungary
    - Regeneron Study Site 2
  - Budapest, Hungary
    - Regeneron Study Site 3
  - Veszprem, Hungary
    - Regeneron Study Site
- Borsod-Abaúj-Zemplén
  - Sátoraljaújhely, Borsod-Abaúj-Zemplén, Hungary
    - Regeneron Study Site
- Békés
  - Oroshaza, Békés, Hungary
    - Regeneron Study Site
- Csongrád
  - Szeged, Csongrád, Hungary
    - Regeneron Study Site
- Jász-Nagykun-Szolnok
  - Szolnok, Jász-Nagykun-Szolnok, Hungary
    - Regeneron Study Site
- Somogy
  - Kaposvár, Somogy, Hungary
    - Regeneron Study Site
Ireland
- - Dublin, Ireland
    - Regeneron Study Site
Italy
- - Ancona, Italy
    - Regeneron Study Site
  - Chieti, Italy
    - Regeneron Study Site
  - Firenze, Italy
    - Regeneron Study Site
  - L'Aquila, Italy
    - Regeneron Study Site
  - Lucca, Italy
    - Regeneron Study Site
  - Messina, Italy
    - Regeneron Study Site
  - Milano, Italy
    - Regeneron Study Site
  - Novara, Italy
    - Regeneron Study Site
  - Pavia, Italy
    - Regeneron Study Site
  - Perugia, Italy
    - Regeneron Study Site
  - Pisa, Italy
    - Regeneron Study Site
  - Roma, Italy
    - Regeneron Study Site 1
  - Roma, Italy
    - Regeneron Study Site 2
- Balogna
  - Bologna, Balogna, Italy
    - Regeneron Study Site
Japan
- - Fukuyama, Japan
    - Regeneron Study Site 2
  - Gifu, Japan
    - Regeneron Study Site
  - Hiroshima, Japan
    - Regeneron Study Site 1
  - Hiroshima, Japan
    - Regeneron Study Site 2
  - Kyoto, Japan
    - Regeneron Study Site 1
  - Kyoto, Japan
    - Regeneron Study Site 2
  - Osaka, Japan
    - Regeneron Study Site 1
  - Osaka, Japan
    - Regeneron Study Site 2
  - Saitama, Japan
    - Regeneron Study Site
  - Shinagawa-ku, Japan
    - Regeneron Study Site 3
  - Suginome, Japan
    - Regeneron Study Site
  - Wakayama, Japan
    - Regeneron Study Site
  - Yokohama, Japan
    - Regeneron Study Site 4
- Aichi
  - Nagakute, Aichi, Japan
    - Regeneron Study Site
- Fukuoka
  - Kurume, Fukuoka, Japan
    - Regeneron Study Site
- Hiroshima
  - Fukuyama, Hiroshima, Japan
    - Regeneron Study Site
- Hokkaido
  - Sapporo, Hokkaido, Japan
    - Regeneron Study Site
- Hukuoka
  - Fukuoka, Hukuoka, Japan
    - Regeneron Study Site 1
  - Fukuoka, Hukuoka, Japan
    - Regeneron Study Site 2
  - Kitakyushu, Hukuoka, Japan
    - Regeneron Study Site
- Hyôgo
  - Amagasaki, Hyôgo, Japan
    - Regeneron Study Site 1
  - Amagasaki, Hyôgo, Japan
    - Regeneron Study Site 2
- Ibaraki
  - Inashiki-gun, Ibaraki, Japan
    - Regeneron Study Site
- Kanagawa
  - Yokohama, Kanagawa, Japan
    - Regeneron Study Site 1
  - Yokohama, Kanagawa, Japan
    - Regeneron Study Site 2
  - Yokohama, Kanagawa, Japan
    - Regeneron Study Site 3
- Kumamoto
  - Kamimashiki, Kumamoto, Japan
    - Regeneron Study Site
- Osaka
  - Habikino, Osaka, Japan
    - Regeneron Study Site
  - Neyagawa, Osaka, Japan
    - Regeneron Study Site
  - Sakai, Osaka, Japan
    - Regeneron Study Site
  - Takatsuki, Osaka, Japan
    - Regeneron Study Site
- Shizuoka
  - Hamamatsu, Shizuoka, Japan
    - Regeneron Study Site
  - Yaizu, Shizuoka, Japan
    - Regeneron Study Site
- Tokyo
  - Bunkyo-ku, Tokyo, Japan
    - Regeneron Study Site 1
  - Bunkyo-ku, Tokyo, Japan
    - Regeneron Study Site 2
  - Chiyoda-ku, Tokyo, Japan
    - Regeneron Study Site 1
  - Chiyoda-ku, Tokyo, Japan
    - Regeneron Study Site 2
  - Chuo-ku, Tokyo, Japan
    - Regeneron Study Site
  - Koto-ku, Tokyo, Japan
    - Regeneron Study Site
  - Nakano-ku, Tokyo, Japan
    - Regeneron Study Site
  - Nerima, Tokyo, Japan
    - Regeneron Study Site 1
  - Nerima, Tokyo, Japan
    - Regeneron Study Site 2
  - Ota-ku, Tokyo, Japan
    - Regeneron Study Site
  - Setagaya-ku, Tokyo, Japan
    - Regeneron Study Site
  - Shibuya-ku, Tokyo, Japan
    - Regeneron Study Site 1
  - Shibuya-ku, Tokyo, Japan
    - Regeneron Study Site 2
  - Shibuya-ku, Tokyo, Japan
    - Regeneron Study Site 3
  - Shinagawa-ku, Tokyo, Japan
    - Regeneron Study Site 1
  - Shinagawa-ku, Tokyo, Japan
    - Regeneron Study Site 2
  - Shinjuku-ku, Tokyo, Japan
    - Regeneron Study Site 1
  - Shinjuku-ku, Tokyo, Japan
    - Regeneron Study Site 2
  - Shinjuku-ku, Tokyo, Japan
    - Regeneron Study Site 3
  - Shinjuku-ku, Tokyo, Japan
    - Regeneron Study Site 4
  - Shinjuku-ku, Tokyo, Japan
    - Regeneron Study Site 5
  - Shinjuku-ku, Tokyo, Japan
    - Regeneron Study Site 6
  - Suginami, Tokyo, Japan
    - Regeneron Study Site 1
  - Suginami, Tokyo, Japan
    - Regeneron Study Site 2
- Yamanashi
  - Kofu, Yamanashi, Japan
    - Regeneron Study Site
- Yamanasi
  - Chuo, Yamanasi, Japan
    - Regeneron Study Site
Korea, Republic of
- - Incheon, Korea, Republic of
    - Regeneron Study Site 1
  - Incheon, Korea, Republic of
    - Regeneron Study Site 2
  - Seoul, Korea, Republic of
    - Regeneron Study Site 1
  - Seoul, Korea, Republic of
    - Regeneron Study Site 2
  - Seoul, Korea, Republic of
    - Regeneron Study Site 3
  - Seoul, Korea, Republic of
    - Regeneron Study Site 4
  - Seoul, Korea, Republic of
    - Regeneron Study Site 5
  - Seoul, Korea, Republic of
    - Regeneron Study Site 6
  - Seoul, Korea, Republic of
    - Regeneron Study Site 7
  - Seoul, Korea, Republic of
    - Regeneron Study Site 8
- Busan Gwang'yeogsi
  - Busan, Busan Gwang'yeogsi, Korea, Republic of
    - Regeneron Study Site
- Kyonggi-do
  - Bucheon-Si, Kyonggi-do, Korea, Republic of
    - Regeneron Study Site
  - Hwaseong-si, Kyonggi-do, Korea, Republic of
    - Regeneron Study Site
  - Suwon, Kyonggi-do, Korea, Republic of
    - Regeneron Study Site
  - Uijeongbu-si, Kyonggi-do, Korea, Republic of
    - Regeneron Study Site
Lithuania
- - Klaipeda, Lithuania
    - Regeneron Study Site 1
  - Klaipeda, Lithuania
    - Regeneron Study Site 2
- Kauno Apskritis
  - Kaunas, Kauno Apskritis, Lithuania
    - Regeneron Study Site
- Vilniaus Apskritis
  - Vilnius, Vilniaus Apskritis, Lithuania
    - Regeneron Study Site 1
  - Vilnius, Vilniaus Apskritis, Lithuania
    - Regeneron Study Site 2
Netherlands
- - Groningen, Netherlands
    - Regeneron Study Site
  - Utrecht, Netherlands
    - Regeneron Study Site
- Noord-Brabant
  - Breda, Noord-Brabant, Netherlands
    - Regeneron Study Site
- Noord-Holland
  - Amsterdam, Noord-Holland, Netherlands
    - Regeneron Study Site
- Zuid-Holland
  - Rotterdam, Zuid-Holland, Netherlands
    - Regeneron Study Site
New Zealand
- - Auckland, New Zealand
    - Regeneron Study Site
- South Island
  - Dunedin, South Island, New Zealand
    - Regeneron Study Site
Poland
- - Bialystok, Poland
    - Regeneron Study Site
  - Bydgoszcz, Poland
    - Regeneron Study Site
  - Chorzow, Poland
    - Regeneron Study Site
  - Elblag, Poland, 82300
    - Regeneron Study Site
  - Katowice, Poland
    - Regeneron Study Site 1
  - Katowice, Poland
    - Regeneron Study Site 2
  - Katowice, Poland
    - Regeneron Study Site 3
  - Ostrowiec Swietokrzyski, Poland
    - Regeneron Study Site
  - Skarzysko-Kamienna, Poland
    - Regeneron Study Site
  - Zgierz, Poland, 95100
    - Regeneron Study Site
- Dolnośląskie
  - Wroclaw, Dolnośląskie, Poland
    - Regeneron Study Site 1
  - Wroclaw, Dolnośląskie, Poland
    - Regeneron Study Site 2
  - Wroclaw, Dolnośląskie, Poland
    - Regeneron Study Site 3
- Kujawsko-pomorskie
  - Torun, Kujawsko-pomorskie, Poland
    - Regeneron Study Site
- Lodzkie
  - Lodz, Lodzkie, Poland
    - Regeneron Study Site 1
  - Lodz, Lodzkie, Poland
    - Regeneron Study Site 2
  - Lodz, Lodzkie, Poland
    - Regeneron Study Site 3
- Lubelskie
  - Lublin, Lubelskie, Poland
    - Regeneron Study Site
- Malopolskie
  - Krakow, Malopolskie, Poland
    - Regeneron Study Site 1
  - Krakow, Malopolskie, Poland
    - Regeneron Study Site 2
  - Krakow, Malopolskie, Poland
    - Regeneron Study Site 3
- Mazowieckie
  - Warszawa, Mazowieckie, Poland
    - Regeneron Study Site 1
  - Warszawa, Mazowieckie, Poland
    - Regeneron Study Site 2
  - Warszawa, Mazowieckie, Poland
    - Regeneron Study Site 3
  - Warszawa, Mazowieckie, Poland
    - Regeneron Study Site 4
  - Warszawa, Mazowieckie, Poland
    - Regeneron Study Site 5
  - Warszawa, Mazowieckie, Poland
    - Regeneron Study Site 6
  - Warszawa, Mazowieckie, Poland
    - Regeneron Study Site 7
- Opolskie
  - Strzelce Opolskie, Opolskie, Poland
    - Regeneron Study Site
- Podkarpackie
  - Iwonicz Zdroj, Podkarpackie, Poland
    - Regeneron Study Site
- Pomorskie
  - Gdansk, Pomorskie, Poland
    - Regeneron Study Site 1
  - Gdansk, Pomorskie, Poland
    - Regeneron Study Site 2
- Wielkopolskie
  - Poznan, Wielkopolskie, Poland
    - Regeneron Study Site 1
  - Poznan, Wielkopolskie, Poland
    - Regeneron Study Site 2
  - Poznan, Wielkopolskie, Poland
    - Regeneron Study Site 3
- Zachodniopomorskie
  - Szczecin, Zachodniopomorskie, Poland
    - Regeneron Study Site
Romania
- - Brasov, Romania
    - Regeneron Study Site
Russian Federation
- - Chelyabinsk, Russian Federation
    - Regeneron Study Site
- Koskva
  - Moscow, Koskva, Russian Federation
    - Regeneron Study Site
- Ryazanskaya Oblast'
  - Ryazan, Ryazanskaya Oblast', Russian Federation
    - Regeneron Study Site
- Sankt-Peterburg
  - Saint Petersburg, Sankt-Peterburg, Russian Federation
    - Regeneron Study Site
- Tatarstan Respublika
  - Kazan, Tatarstan Respublika, Russian Federation
    - Regeneron Study Site
Singapore
- Central Singapore
  - Singapore, Central Singapore, Singapore
    - Regeneron Study Site 1
  - Singapore, Central Singapore, Singapore
    - Regeneron Study Site 2
- South West
  - Singapore, South West, Singapore
    - Regeneron Study Site
Slovakia
- - Kosice, Slovakia
    - Regeneron Study Site
  - Svidnik, Slovakia
    - Regeneron Study Site
Spain
- - Barcelona, Spain
    - Regeneron Study Site 1
  - Barcelona, Spain
    - Regeneron Study Site 2
  - Barcelona, Spain
    - Regeneron Study Site 3
  - Barcelona, Spain
    - Regeneron Study Site 4
  - Madrid, Spain
    - Regeneron Study Site 1
  - Madrid, Spain
    - Regeneron Study Site 2
  - Sevilla, Spain
    - Regeneron Study Site
- Alicante
  - Elche, Alicante, Spain
    - Regeneron Study Site
- Barcelona
  - Badalona, Barcelona, Spain
    - Regeneron Study Site
- Canarias
  - Las Palmas de Gran Canaria, Canarias, Spain
    - Regeneron Study Site
United Kingdom
- - Liverpool, United Kingdom
    - Regeneron Study Site
  - London, United Kingdom
    - Regeneron Study Site 1
  - London, United Kingdom
    - Regeneron Study Site 2
  - Manchester, United Kingdom
    - Regeneron Study Site
  - Salford, United Kingdom
    - Regeneron Study Site
  - Sheffield, United Kingdom
    - Regeneron Study Site
- Angus
  - Dundee, Angus, United Kingdom
    - Regeneron Study Site
- Birmingham
  - Edgbaston, Birmingham, United Kingdom
    - Regeneron Study Site
- Devon
  - Plymouth, Devon, United Kingdom
    - Regeneron Study Site
- Hampshire
  - Portsmouth, Hampshire, United Kingdom
    - Regeneron Study Site
- Kent
  - Sidcup, Kent, United Kingdom
    - Regeneron Study Site
- London
  - Northwood, London, United Kingdom
    - Regeneron Study Site
- Oxfordshire
  - Oxford, Oxfordshire, United Kingdom
    - Regeneron Study Site
United States
- Alabama
  - Anniston, Alabama, United States, 36207
    - Regeneron Study Site
  - Birmingham, Alabama, United States, 35205
    - Regeneron Study Site
  - Birmingham, Alabama, United States, 35209
    - Regeneron Study Site 1
  - Birmingham, Alabama, United States, 35233
    - Regeneron Study Site 2
- Arizona
  - Phoenix, Arizona, United States, 85018
    - Regeneron Study Site 2
  - Phoenix, Arizona, United States, 85023
    - Regeneron Study Site 3
  - Phoenix, Arizona, United States, 85032
    - Regeneron Study Site 1
- Arkansas
  - Fort Smith, Arkansas, United States, 72916
    - Regeneron Study Site
  - Rogers, Arkansas, United States, 72758
    - Regeneron Study Site
- California
  - Bakersfield, California, United States, 93309
    - Regeneron Study Site
  - Clovis, California, United States, 93612
    - Regeneron Study Site
  - Costa Mesa, California, United States, 92626
    - Regeneron Study Site
  - Encinitas, California, United States, 92024
    - Regeneron Study Site
  - Fremont, California, United States, 94538
    - Regeneron Study Site
  - Lomita, California, United States, 90717
    - Regeneron Study Site
  - Long Beach, California, United States, 90808
    - Regeneron Study Site
  - Los Angeles, California, United States, 90025
    - Regeneron Study Site 1
  - Los Angeles, California, United States, 90025
    - Regeneron Study Site 2
  - Los Angeles, California, United States, 90045
    - Regeneron Study Site
  - Oceanside, California, United States, 92056
    - Regeneron Study Site
  - Orange, California, United States, 92868
    - Regeneron Study Site
  - Rolling Hills Estates, California, United States, 90274
    - Regeneron Study Site
  - San Diego, California, United States, 92122
    - Regeneron Study Site
  - San Diego, California, United States, 92123
    - Regeneron Study Site 1
  - San Diego, California, United States, 92123
    - Regeneron Study Site 2
  - Santa Monica, California, United States, 90404
    - Regeneron Study Site
- Colorado
  - Centennial, Colorado, United States, 80112
    - Regeneron Study Site
  - Denver, Colorado, United States, 80206
    - Regeneron Study Site
  - Denver, Colorado, United States, 80220
    - Regeneron Study Site
- Connecticut
  - Trumbull, Connecticut, United States, 06611
    - Regeneron Study Site
- District of Columbia
  - Washington, District of Columbia, United States, 20037
    - Regeneron Study Site
- Florida
  - Boca Raton, Florida, United States, 33486
    - Regeneron Study Site
  - Clearwater, Florida, United States, 33756
    - Regeneron Study Site
  - Fort Lauderdale, Florida, United States, 33306
    - Regeneron Study Site
  - Jacksonville, Florida, United States, 32216
    - Regeneron Study Site 1
  - Jacksonville, Florida, United States, 32216
    - Regeneron Study Site 2
  - Lake Worth, Florida, United States, 33461
    - Regeneron Study Site
  - Miami, Florida, United States, 33144
    - Regeneron Study Site
  - Miami, Florida, United States, 33135
    - Regeneron Study Site
  - Miami Lakes, Florida, United States, 33016
    - Regeneron Study Site
  - Orlando, Florida, United States, 32806
    - Regeneron Study Site
  - Tampa, Florida, United States, 33607
    - Regeneron Study Site
  - Tampa, Florida, United States, 33614
    - Regeneron Study Site
  - Tampa, Florida, United States, 33624
    - Regeneron Study Site
  - West Palm Beach, Florida, United States, 33406
    - Regeneron Study Site
- Georgia
  - Alpharetta, Georgia, United States, 30022
    - Regeneron Study Site
  - Atlanta, Georgia, United States, 30322
    - Regeneron Study Site
  - Columbus, Georgia, United States, 31904
    - Regeneron Study Site
  - Macon, Georgia, United States, 31217
    - Regeneron Study Site
  - Newnan, Georgia, United States, 30263
    - Regeneron Study Site
  - Sandy Springs, Georgia, United States, 30328
    - Regeneron Study Site
  - Savannah, Georgia, United States, 31405
    - Regeneron Study Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - Regeneron Study Site
  - Normal, Illinois, United States, 61761
    - Regeneron Study Site
  - West Dundee, Illinois, United States, 60118
    - Regeneron Study Site
- Indiana
  - Indianapolis, Indiana, United States, 46250
    - Regeneron Study Site
  - Newburgh, Indiana, United States, 47630
    - Regeneron Study Site
  - Plainfield, Indiana, United States, 46168
    - Regeneron Study Site
- Kansas
  - Overland Park, Kansas, United States, 66215
    - Regeneron Study Site
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Regeneron Study Site
- Maryland
  - Rockville, Maryland, United States, 20850
    - Regeneron Study Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Regeneron Study Site
  - Boston, Massachusetts, United States, 02111
    - Regeneron Study Site
  - Boston, Massachusetts, United States, 02115
    - Regeneron Study Site
- Michigan
  - Bay City, Michigan, United States, 48706
    - Regeneron Study Site
  - Farmington Hills, Michigan, United States, 48334
    - Regeneron Study Site
  - Troy, Michigan, United States, 48084
    - Regeneron Study Site
- Minnesota
  - Edina, Minnesota, United States, 55435
    - Regeneron Study Site
  - Fridley, Minnesota, United States, 55432
    - Regeneron Study Site
  - Minneapolis, Minnesota, United States, 55402
    - Regeneron Study Site
  - Plymouth, Minnesota, United States, 55402
    - Regeneron Study Site
- Missouri
  - Saint Joseph, Missouri, United States, 64506
    - Regeneron Study Site
  - Saint Louis, Missouri, United States, 63104
    - Regeneron Study Site
  - Saint Louis, Missouri, United States, 63141
    - Regeneron Study Site
- Nevada
  - Henderson, Nevada, United States, 89052
    - Regeneron Study Site
  - Las Vegas, Nevada, United States, 89119
    - Regeneron Study Site
- New Hampshire
  - Portsmouth, New Hampshire, United States, 03801
    - Regeneron Study Site
- New Jersey
  - Berlin, New Jersey, United States, 08009
    - Regeneron Study Site
  - East Windsor, New Jersey, United States, 08520
    - Regeneron Study Site
  - Verona, New Jersey, United States, 07044-2946
    - Regeneron Study Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - Regeneron Study Site 1
  - Albuquerque, New Mexico, United States, 87106
    - Regeneron Study Site 2
- New York
  - Buffalo, New York, United States, 14203
    - Regeneron Study Site
  - Corning, New York, United States, 14830
    - Regeneron Study Site
  - Forest Hills, New York, United States, 11375
    - Regeneron Study Site
  - New York, New York, United States, 10016
    - Regeneron Study Site
  - New York, New York, United States, 10075
    - Regeneron Study Site
  - New York, New York, United States, 10021
    - Regeneron Study Site
  - New York, New York, United States, 10029-6501
    - Regeneron Study Site
  - Rochester, New York, United States, 14642
    - Regeneron Study Site
- North Carolina
  - Chapel Hill, North Carolina, United States, 27516
    - Regeneron Study Site
  - High Point, North Carolina, United States, 27262
    - Regeneron Study Site
  - Raleigh, North Carolina, United States, 27612
    - Regeneron Study Site
  - Wilmington, North Carolina, United States, 28405
    - Regeneron Study Site
  - Winston-Salem, North Carolina, United States, 27104
    - Regeneron Study Site
- Ohio
  - Cincinnati, Ohio, United States, 45231
    - Regeneron Study Site
  - Cleveland, Ohio, United States, 44106
    - Regeneron Study Site
- Oklahoma
  - Norman, Oklahoma, United States, 73071
    - Regeneron Study Site
  - Tulsa, Oklahoma, United States, 74136
    - Regeneron Study Site
- Oregon
  - Medford, Oregon, United States, 97504-9741
    - Regeneron Study Site
  - Portland, Oregon, United States, 97239
    - Regeneron Study Site
  - Portland, Oregon, United States, 97223
    - Regeneron Study Site
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18020
    - Regeneron Study Site
  - Jenkintown, Pennsylvania, United States, 19046
    - Regeneron Study Site
  - Philadelphia, Pennsylvania, United States, 19104
    - Regeneron Study Site
  - Pittsburgh, Pennsylvania, United States, 15213
    - Regeneron Study Site
- South Carolina
  - Charleston, South Carolina, United States, 29407
    - Regeneron Study Site
  - Greer, South Carolina, United States, 29650
    - Regeneron Study Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - Regeneron Study Site
  - Nashville, Tennessee, United States, 37215
    - Regeneron Study Site
- Texas
  - Arlington, Texas, United States, 76011
    - Regeneron Study Site
  - Austin, Texas, United States, 78705
    - Regeneron Study Site
  - Bellaire, Texas, United States, 77401-3505
    - Regeneron Study Site
  - Dallas, Texas, United States, 75231
    - Regeneron Study Site
  - Dallas, Texas, United States, 75246
    - Regeneron Study Site
  - Dallas, Texas, United States, 75230
    - Regeneron Study Site
  - Houston, Texas, United States, 77004
    - Regeneron Study Site
  - San Antonio, Texas, United States, 78218
    - Regeneron Study Site
  - San Antonio, Texas, United States, 78258
    - Regeneron Study Site
  - San Antonio, Texas, United States, 78229
    - Regeneron Study Site 1
  - San Antonio, Texas, United States, 78229
    - Regeneron Study Site 2
  - Waco, Texas, United States, 76710
    - Regeneron Study Site
  - Webster, Texas, United States, 77598
    - Regeneron Study Site
- Utah
  - Salt Lake City, Utah, United States, 84132
    - Regeneron Study Site
- Vermont
  - South Burlington, Vermont, United States, 05403
    - Regeneron Study Site
- Virginia
  - Newport News, Virginia, United States, 23606-4537
    - Regeneron Study Site
  - Norfolk, Virginia, United States, 23502
    - Regeneron Study Site
  - Richmond, Virginia, United States, 23220
    - Regeneron Study Site
- Washington
  - Seattle, Washington, United States, 98101
    - Regeneron Study Site

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Key Inclusion Criteria:

Participation in a prior clinical trial of dupilumab for AD and met one of the following:
1. 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
2. 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.
3. 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
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

Key Exclusion Criteria:

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

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.

Study Plan

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

How is the study designed?

Design Details

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dupilumab Participants will receive repeat doses of dupilumab	Drug: Dupilumab Other Names: REGN668 SAR231893 DUPIXENT®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment Emergent Adverse Events (TEAEs) Time Frame: Up to 272 weeks		Up to 272 weeks
OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product Time Frame: Up to 24 Weeks	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)	Up to 24 Weeks

Secondary Outcome Measures

Collaborators and Investigators

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

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

Investigators

Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

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

General Publications

Study record dates

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

Study Major Dates

Study Start (Actual)

October 10, 2013

Primary Completion (Actual)

June 27, 2022

Study Completion (Actual)

June 27, 2022

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

September 20, 2013

First Posted (Estimated)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

R668-AD-1225
2013-001449-15 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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

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Outcome Measure	Measure Description	Time Frame
Number of Serious Adverse Events (SAEs) of Special Interest Time Frame: Up to 272 weeks	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)	Up to 272 weeks
Rate of AESIs Time Frame: Up to 272 weeks	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)	Up to 272 weeks
Number of AESIs Time Frame: Up to 272 weeks	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)	Up to 272 weeks
Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit Time Frame: 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)	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.	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)
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 Time Frame: 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)"	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.	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)"
Percentage of Participants With Low Disease Activity State (eg, IGA ≤2) at Each Visit Time Frame: 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)"	Low disease activity state is defined as an IGA score of ≤2 [mild = 2, almost clear = 1, or clear = 0]	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)"
Change From Baseline in EASI Score at Each Visit Time Frame: 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)"	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.	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)"
Percent Change From Baseline in EASI Score at Each Visit Time Frame: 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)"	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.	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)"
Percentage of Participants With EASI-50 (≥50% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit Time Frame: 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)"	EASI-50 was defined as >=50% reduction in EASI scores from baseline of the parent study	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)"
Percentage of Participants With EASI-90 (≥90% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit Time Frame: 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)"	EASI-90 was defined as >=90% reduction in EASI scores from baseline of the parent study	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)"
Change From Baseline in Pruritus Numerical Rating Scale (NRS) in Parent Study Time Frame: 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)"	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	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)"
Percent Change From Baseline in Pruritus NRS Time Frame: 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)"	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	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)"
Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥3 From Baseline Time Frame: 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)"	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	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)"
Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥4 From Baseline Time Frame: 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)"	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	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)"
Percentage of Participants Requiring Rescue Treatment: Overall Time Frame: Up to 272 weeks		Up to 272 weeks
Percentage of Participants Requiring Rescue Treatment: Systemic Treatment Time Frame: Up to 272 weeks		Up to 272 weeks
Percentage of Participants Requiring Rescue Treatment: Phototherapy Time Frame: Up to 272 weeks		Up to 272 weeks
Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Dermatology Life Quality Index (DLQI) Time Frame: Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"	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	Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Patient Oriented Eczema Measure (POEM) Time Frame: Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"	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.	Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
Changes From Parent Study Baseline to Prespecified Time Points Through the End of the Study: EuroQol-5D (EQ-5D) Time Frame: Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"	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).	Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
OPTIONAL SUB-STUDY: Ctrough of Functional Dupilumab in Serum Before and After Switching to the New Dupilumab Drug Product Time Frame: Up to week 12		Up to week 12
OPTIONAL SUB-STUDY: Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response in Patients Receiving the New Dupilumab Drug Product Time Frame: Up to 24 Weeks	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.	Up to 24 Weeks

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

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

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