Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949311
• Other study ID #: R668-AD-1225
• Secondary ID: 2013-001449-15
• Status: Completed
• Phase: Phase 3
• Start date: October 10, 2013
• Est. completion date: June 27, 2022

Study information

• Verified date: October 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2733
• Est. completion date: June 27, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. 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.

2. Willing and able to comply with all clinic visits and study-related procedures

3. Able to understand and complete study-related questionnaires

4. Provide signed informed consent

Optional Sub-Study:

1. Provide separate informed consent

2. Continuing in the treatment period of the main OLE study

3. Demonstrated compliance with dupilumab therapy, as defined in the protocol

Key Exclusion Criteria:

1. 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.

2. 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.

3. 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.

4. 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

5. 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Dupilumab

Locations

Country	Name	City	State
Australia	Regeneron Study Site	Benowa	Queensland
Australia	Regeneron Study Site	Carlton	Victoria
Australia	Regeneron Study Site	East Melbourne	Victoria
Australia	Regeneron Study Site	Fremantle	Western Australia
Australia	Regeneron Study Site	Hectorville	South Australia
Australia	Regeneron Study Site	Kogarah	New South Wales
Australia	Regeneron Study Site	Phillip	Australian Capital Territory
Australia	Regeneron Study Site	Woolloongabba	Queensland
Austria	Regeneron Study Site 1	Wien
Austria	Regeneron Study Site 2	Wien
Belgium	Regeneron Study Site	Bruxelles	Brussels Capital Region
Belgium	Regeneron Study Site	Leuven	Vlaams Brabant
Belgium	Regeneron Study Site	Loverval	Hainaut
Bulgaria	Regeneron Study Site	Dupnitsa	Kjustendil
Bulgaria	Regeneron Study Site 1	Sofia	Sofia-Grad
Bulgaria	Regeneron Study Site 2	Sofia	Sofia-Grad
Canada	Regeneron Study Site	Ajax	Ontario
Canada	Regeneron Study Site 1	Barrie	Ontario
Canada	Regeneron Study Site 2	Barrie	Ontario
Canada	Regeneron Study Site	Bathurst	New Brunswick
Canada	Regeneron Study Site 1	Calgary	Alberta
Canada	Regeneron Study Site 2	Calgary	Alberta
Canada	Regeneron Study Site	Drummondville	Quebec
Canada	Regeneron Study Site 1	Edmonton	Alberta
Canada	Regeneron Study Site 2	Edmonton	Alberta
Canada	Regeneron Study Site	Etobicoke	Ontario
Canada	Regeneron Study Site 1	Hamilton	Ontario
Canada	Regeneron Study Site 2	Hamilton	Ontario
Canada	Regeneron Study Site	Markham	Ontario
Canada	Regeneron Study Site	Mississauga	Ontario
Canada	Regeneron Study Site	Montreal	Quebec
Canada	Regeneron Study Site	Newmarket	Ontario
Canada	Regeneron Study Site	North Bay	Ontario
Canada	Regeneron Study Site	Oakville	Ontario
Canada	Regeneron Study Site 1	Ottawa	Ontario
Canada	Regeneron Study Site	Peterborough	Ontario
Canada	Regeneron Study Site 1	Richmond Hill	Ontario
Canada	Regeneron Study Site 2	Richmond Hill	Ontario
Canada	Regeneron Study Site	St. John's	Newfoundland and Labrador
Canada	Regeneron Study Site	Ste-Foy
Canada	Regeneron Study Site 3	Ste-Foy	Quebec
Canada	Regeneron Study Site 1	Surrey	British Columbia
Canada	Regeneron Study Site 2	Surrey	British Columbia
Canada	Regeneron Study Site	Toronto	Ontario
Canada	Regeneron Study Site 1	Vancouver	British Columbia
Canada	Regeneron Study Site 2	Vancouver	British Columbia
Canada	Regeneron Study Site 3	Vancouver	British Columbia
Canada	Regeneron Study Site	Waterloo	Ontario
Canada	Regeneron Study Site 1	Windsor	Ontario
Canada	Regeneron Study Site 2	Windsor	Ontario
Canada	Regeneron Study Site	Winnipeg
Canada	Regeneron Study Site 1	Winnipeg	Manitoba
China	Regeneron Study Site	Hong Kong
Czechia	Regeneron Study Site	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
Denmark	Regeneron Study Site	Aarhus	Central Jutland
Denmark	Regeneron Study Site	Copenhagen	Capital
Denmark	Regeneron Study Site	Hellerup	Capital
Denmark	Regeneron Study Site	Roskilde	Zeeland
Estonia	Regeneron Study Site 1	Tallinn	Harjumaa
Estonia	Regeneron Study Site 2	Tallinn	Harjumaa
Estonia	Regeneron Study Site 3	Tallinn	Harjumaa
Estonia	Regeneron Study Site 1	Tartu	Tartumaa
Estonia	Regeneron Study Site 2	Tartu	Tartumaa
Finland	Regeneron Study Site	Helsinki	Etelä-Suomen Iääni
Finland	Regeneron Study Site	Tampere	Länsi-Suomen Lääni
Finland	Regeneron Study Site	Turku	Etelä-Suomen Lääni
France	Regeneron Study Site	Lille	Nord
France	Regeneron Study Site	Lille cedex
France	Regeneron Study Site	Marseille	Bouches-du-Rhône
France	Regeneron Study Site	Nantes
France	Regeneron Study Site	Nice Cedex 3	Alpes-Maritimes
France	Regeneron Study Site	Paris	Île-de-France
France	Regeneron Study Site	Pierre Benite	Rhône-Alpes
France	Regeneron Study Site	Reims	Marne
Germany	Regeneron Study Site	Augsburg	Bayern
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	Berlin
Germany	Regeneron Study Site 1	Bochum	Nordrhein-Westfalen
Germany	Regeneron Study Site 2	Bochum	Nordrhein-Westfalen
Germany	Regeneron Study Site	Bonn
Germany	Regeneron Study Site	Darmstadt
Germany	Regeneron Study Site 1	Dresden	Sachsen
Germany	Regeneron Study Site 2	Dresden	Sachsen
Germany	Regeneron Study Site 3	Dresden	Sachsen
Germany	Regeneron Study Site	Dulmen	Nordrhein-Westfalen
Germany	Regeneron Study Site	Erlangen	Bayern
Germany	Regeneron Study Site	Frankfurt/Main	Hessen
Germany	Regeneron Study Site	Friedrichshafen	Baden-Württemberg
Germany	Regeneron Study Site	Gera	Thüringen
Germany	Regeneron Study Site	Halle	Sachsen-Anhalt
Germany	Regeneron Study Site 1	Hamburg
Germany	Regeneron Study Site 2	Hamburg	Hamburgh
Germany	Regeneron Study Site	Hannover	Niedersachsen
Germany	Regeneron Study Site	Heidelberg	Baden-Württemberg
Germany	Regeneron Study Site	Ibbenbüren	Nordrhein-Westfalen
Germany	Regeneron Study Site 1	Kiel	Schleswig-Holstein
Germany	Regeneron Study Site 2	Kiel	Schleswig-Holstein
Germany	Regeneron Study Site	Langenau	Baden-Württemberg
Germany	Regeneron Study Site	Leipzig	Sachsen
Germany	Regeneron Study Site	Lubeck	Schleswig-Holstein
Germany	Regeneron Study Site	Magdeburg	Sachsen-Anhalt
Germany	Regeneron Study Site	Mahlow	Brandenburg
Germany	Regeneron Study Site	Mainz	Rheinland-Pfalz
Germany	Regeneron Study Site	Monchengladbach	Nordrhein-Westfalen
Germany	Regeneron Study Site	Muenster	Nordrhein-Westfalen
Germany	Regeneron Study Site	Munchen	Bayern
Germany	Regeneron Study Site	Munich	Bayern
Germany	Regeneron Study Site	Münster
Germany	Regeneron Study Site	Osnabrück
Germany	Regeneron Study Site	Schwerin	Mecklenburg-Vorpommern
Germany	Regeneron Study Site	Selters	Rheinland-Pfalz
Germany	Regeneron Study Site	Stuttgart	Baden-Württemberg
Germany	Regeneron Study Site	Tuebingen	Baden-Württemberg
Hungary	Regeneron Study Site 1	Budapest
Hungary	Regeneron Study Site 2	Budapest
Hungary	Regeneron Study Site 3	Budapest
Hungary	Regeneron Study Site	Kaposvár	Somogy
Hungary	Regeneron Study Site	Oroshaza	Békés
Hungary	Regeneron Study Site	Sátoraljaújhely	Borsod-Abaúj-Zemplén
Hungary	Regeneron Study Site	Szeged	Csongrád
Hungary	Regeneron Study Site	Szolnok	Jász-Nagykun-Szolnok
Hungary	Regeneron Study Site	Veszprem
Ireland	Regeneron Study Site	Dublin
Italy	Regeneron Study Site	Ancona
Italy	Regeneron Study Site	Bologna	Balogna
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 1	Roma
Italy	Regeneron Study Site 2	Roma
Japan	Regeneron Study Site 1	Amagasaki	Hyôgo
Japan	Regeneron Study Site 2	Amagasaki	Hyôgo
Japan	Regeneron Study Site 1	Bunkyo-ku	Tokyo
Japan	Regeneron Study Site 2	Bunkyo-ku	Tokyo
Japan	Regeneron Study Site 1	Chiyoda-ku	Tokyo
Japan	Regeneron Study Site 2	Chiyoda-ku	Tokyo
Japan	Regeneron Study Site	Chuo	Yamanasi
Japan	Regeneron Study Site	Chuo-ku	Tokyo
Japan	Regeneron Study Site 1	Fukuoka	Hukuoka
Japan	Regeneron Study Site 2	Fukuoka	Hukuoka
Japan	Regeneron Study Site	Fukuyama	Hiroshima
Japan	Regeneron Study Site 2	Fukuyama
Japan	Regeneron Study Site	Gifu
Japan	Regeneron Study Site	Habikino	Osaka
Japan	Regeneron Study Site	Hamamatsu	Shizuoka
Japan	Regeneron Study Site 1	Hiroshima
Japan	Regeneron Study Site 2	Hiroshima
Japan	Regeneron Study Site	Inashiki-gun	Ibaraki
Japan	Regeneron Study Site	Kamimashiki	Kumamoto
Japan	Regeneron Study Site	Kitakyushu	Hukuoka
Japan	Regeneron Study Site	Kofu	Yamanashi
Japan	Regeneron Study Site	Koto-ku	Tokyo
Japan	Regeneron Study Site	Kurume	Fukuoka
Japan	Regeneron Study Site 1	Kyoto
Japan	Regeneron Study Site 2	Kyoto
Japan	Regeneron Study Site	Nagakute	Aichi
Japan	Regeneron Study Site	Nakano-ku	Tokyo
Japan	Regeneron Study Site 1	Nerima	Tokyo
Japan	Regeneron Study Site 2	Nerima	Tokyo
Japan	Regeneron Study Site	Neyagawa	Osaka
Japan	Regeneron Study Site 1	Osaka
Japan	Regeneron Study Site 2	Osaka
Japan	Regeneron Study Site	Ota-ku	Tokyo
Japan	Regeneron Study Site	Saitama
Japan	Regeneron Study Site	Sakai	Osaka
Japan	Regeneron Study Site	Sapporo	Hokkaido
Japan	Regeneron Study Site	Setagaya-ku	Tokyo
Japan	Regeneron Study Site 1	Shibuya-ku	Tokyo
Japan	Regeneron Study Site 2	Shibuya-ku	Tokyo
Japan	Regeneron Study Site 3	Shibuya-ku	Tokyo
Japan	Regeneron Study Site 1	Shinagawa-ku	Tokyo
Japan	Regeneron Study Site 2	Shinagawa-ku	Tokyo
Japan	Regeneron Study Site 3	Shinagawa-ku
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	Shinjuku-ku	Tokyo
Japan	Regeneron Study Site 1	Suginami	Tokyo
Japan	Regeneron Study Site 2	Suginami	Tokyo
Japan	Regeneron Study Site	Suginome
Japan	Regeneron Study Site	Takatsuki	Osaka
Japan	Regeneron Study Site	Wakayama
Japan	Regeneron Study Site	Yaizu	Shizuoka
Japan	Regeneron Study Site 1	Yokohama	Kanagawa
Japan	Regeneron Study Site 2	Yokohama	Kanagawa
Japan	Regeneron Study Site 3	Yokohama	Kanagawa
Japan	Regeneron Study Site 4	Yokohama
Korea, Republic of	Regeneron Study Site	Bucheon-Si	Kyonggi-do
Korea, Republic of	Regeneron Study Site	Busan	Busan Gwang'yeogsi
Korea, Republic of	Regeneron Study Site	Hwaseong-si	Kyonggi-do
Korea, Republic of	Regeneron Study Site 1	Incheon
Korea, Republic of	Regeneron Study Site 2	Incheon
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	Seoul
Korea, Republic of	Regeneron Study Site	Suwon	Kyonggi-do
Korea, Republic of	Regeneron Study Site	Uijeongbu-si	Kyonggi-do
Lithuania	Regeneron Study Site	Kaunas	Kauno Apskritis
Lithuania	Regeneron Study Site 1	Klaipeda
Lithuania	Regeneron Study Site 2	Klaipeda
Lithuania	Regeneron Study Site 1	Vilnius	Vilniaus Apskritis
Lithuania	Regeneron Study Site 2	Vilnius	Vilniaus Apskritis
Netherlands	Regeneron Study Site	Amsterdam	Noord-Holland
Netherlands	Regeneron Study Site	Breda	Noord-Brabant
Netherlands	Regeneron Study Site	Groningen
Netherlands	Regeneron Study Site	Rotterdam	Zuid-Holland
Netherlands	Regeneron Study Site	Utrecht
New Zealand	Regeneron Study Site	Auckland
New Zealand	Regeneron Study Site	Dunedin	South Island
Poland	Regeneron Study Site	Bialystok
Poland	Regeneron Study Site	Bydgoszcz
Poland	Regeneron Study Site	Chorzow
Poland	Regeneron Study Site	Elblag
Poland	Regeneron Study Site 1	Gdansk	Pomorskie
Poland	Regeneron Study Site 2	Gdansk	Pomorskie
Poland	Regeneron Study Site	Iwonicz Zdroj	Podkarpackie
Poland	Regeneron Study Site 1	Katowice
Poland	Regeneron Study Site 2	Katowice
Poland	Regeneron Study Site 3	Katowice
Poland	Regeneron Study Site 1	Krakow	Malopolskie
Poland	Regeneron Study Site 2	Krakow	Malopolskie
Poland	Regeneron Study Site 3	Krakow	Malopolskie
Poland	Regeneron Study Site 1	Lodz	Lodzkie
Poland	Regeneron Study Site 2	Lodz	Lodzkie
Poland	Regeneron Study Site 3	Lodz	Lodzkie
Poland	Regeneron Study Site	Lublin	Lubelskie
Poland	Regeneron Study Site	Ostrowiec Swietokrzyski
Poland	Regeneron Study Site 1	Poznan	Wielkopolskie
Poland	Regeneron Study Site 2	Poznan	Wielkopolskie
Poland	Regeneron Study Site 3	Poznan	Wielkopolskie
Poland	Regeneron Study Site	Skarzysko-Kamienna
Poland	Regeneron Study Site	Strzelce Opolskie	Opolskie
Poland	Regeneron Study Site	Szczecin	Zachodniopomorskie
Poland	Regeneron Study Site	Torun	Kujawsko-pomorskie
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	Warszawa	Mazowieckie
Poland	Regeneron Study Site 1	Wroclaw	Dolnoslaskie
Poland	Regeneron Study Site 2	Wroclaw	Dolnoslaskie
Poland	Regeneron Study Site 3	Wroclaw	Dolnoslaskie
Poland	Regeneron Study Site	Zgierz
Romania	Regeneron Study Site	Brasov
Russian Federation	Regeneron Study Site	Chelyabinsk
Russian Federation	Regeneron Study Site	Kazan	Tatarstan Respublika
Russian Federation	Regeneron Study Site	Moscow	Koskva
Russian Federation	Regeneron Study Site	Ryazan	Ryazanskaya Oblast'
Russian Federation	Regeneron Study Site	Saint Petersburg	Sankt-Peterburg
Singapore	Regeneron Study Site	Singapore	South West
Singapore	Regeneron Study Site 1	Singapore	Central Singapore
Singapore	Regeneron Study Site 2	Singapore	Central Singapore
Slovakia	Regeneron Study Site	Kosice
Slovakia	Regeneron Study Site	Svidnik
Spain	Regeneron Study Site	Badalona	Barcelona
Spain	Regeneron Study Site 1	Barcelona
Spain	Regeneron Study Site 2	Barcelona
Spain	Regeneron Study Site 3	Barcelona
Spain	Regeneron Study Site 4	Barcelona
Spain	Regeneron Study Site	Elche	Alicante
Spain	Regeneron Study Site	Las Palmas de Gran Canaria	Canarias
Spain	Regeneron Study Site 1	Madrid
Spain	Regeneron Study Site 2	Madrid
Spain	Regeneron Study Site	Sevilla
United Kingdom	Regeneron Study Site	Dundee	Angus
United Kingdom	Regeneron Study Site	Edgbaston	Birmingham
United Kingdom	Regeneron Study Site	Liverpool
United Kingdom	Regeneron Study Site 1	London
United Kingdom	Regeneron Study Site 2	London
United Kingdom	Regeneron Study Site	Manchester
United Kingdom	Regeneron Study Site	Northwood	London
United Kingdom	Regeneron Study Site	Oxford	Oxfordshire
United Kingdom	Regeneron Study Site	Plymouth	Devon
United Kingdom	Regeneron Study Site	Portsmouth	Hampshire
United Kingdom	Regeneron Study Site	Salford
United Kingdom	Regeneron Study Site	Sheffield
United Kingdom	Regeneron Study Site	Sidcup	Kent
United States	Regeneron Study Site 1	Albuquerque	New Mexico
United States	Regeneron Study Site 2	Albuquerque	New Mexico
United States	Regeneron Study Site	Alpharetta	Georgia
United States	Regeneron Study Site	Anniston	Alabama
United States	Regeneron Study Site	Arlington	Texas
United States	Regeneron Study Site	Atlanta	Georgia
United States	Regeneron Study Site	Austin	Texas
United States	Regeneron Study Site	Bakersfield	California
United States	Regeneron Study Site	Bay City	Michigan
United States	Regeneron Study Site	Bellaire	Texas
United States	Regeneron Study Site	Berlin	New Jersey
United States	Regeneron Study Site	Bethlehem	Pennsylvania
United States	Regeneron Study Site	Birmingham	Alabama
United States	Regeneron Study Site 1	Birmingham	Alabama
United States	Regeneron Study Site 2	Birmingham	Alabama
United States	Regeneron Study Site	Boca Raton	Florida
United States	Regeneron Study Site	Boston	Massachusetts
United States	Regeneron Study Site	Boston	Massachusetts
United States	Regeneron Study Site	Boston	Massachusetts
United States	Regeneron Study Site	Buffalo	New York
United States	Regeneron Study Site	Centennial	Colorado
United States	Regeneron Study Site	Chapel Hill	North Carolina
United States	Regeneron Study Site	Charleston	South Carolina
United States	Regeneron Study Site	Chattanooga	Tennessee
United States	Regeneron Study Site	Chicago	Illinois
United States	Regeneron Study Site	Cincinnati	Ohio
United States	Regeneron Study Site	Clearwater	Florida
United States	Regeneron Study Site	Cleveland	Ohio
United States	Regeneron Study Site	Clovis	California
United States	Regeneron Study Site	Columbus	Georgia
United States	Regeneron Study Site	Corning	New York
United States	Regeneron Study Site	Costa Mesa	California
United States	Regeneron Study Site	Dallas	Texas
United States	Regeneron Study Site	Dallas	Texas
United States	Regeneron Study Site	Dallas	Texas
United States	Regeneron Study Site	Denver	Colorado
United States	Regeneron Study Site	Denver	Colorado
United States	Regeneron Study Site	East Windsor	New Jersey
United States	Regeneron Study Site	Edina	Minnesota
United States	Regeneron Study Site	Encinitas	California
United States	Regeneron Study Site	Farmington Hills	Michigan
United States	Regeneron Study Site	Forest Hills	New York
United States	Regeneron Study Site	Fort Lauderdale	Florida
United States	Regeneron Study Site	Fort Smith	Arkansas
United States	Regeneron Study Site	Fremont	California
United States	Regeneron Study Site	Fridley	Minnesota
United States	Regeneron Study Site	Greer	South Carolina
United States	Regeneron Study Site	Henderson	Nevada
United States	Regeneron Study Site	High Point	North Carolina
United States	Regeneron Study Site	Houston	Texas
United States	Regeneron Study Site	Indianapolis	Indiana
United States	Regeneron Study Site 1	Jacksonville	Florida
United States	Regeneron Study Site 2	Jacksonville	Florida
United States	Regeneron Study Site	Jenkintown	Pennsylvania
United States	Regeneron Study Site	Lake Worth	Florida
United States	Regeneron Study Site	Las Vegas	Nevada
United States	Regeneron Study Site	Lomita	California
United States	Regeneron Study Site	Long Beach	California
United States	Regeneron Study Site	Los Angeles	California
United States	Regeneron Study Site 1	Los Angeles	California
United States	Regeneron Study Site 2	Los Angeles	California
United States	Regeneron Study Site	Macon	Georgia
United States	Regeneron Study Site	Medford	Oregon
United States	Regeneron Study Site	Miami	Florida
United States	Regeneron Study Site	Miami	Florida
United States	Regeneron Study Site	Miami Lakes	Florida
United States	Regeneron Study Site	Minneapolis	Minnesota
United States	Regeneron Study Site	Nashville	Tennessee
United States	Regeneron Study Site	New Orleans	Louisiana
United States	Regeneron Study Site	New York	New York
United States	Regeneron Study Site	New York	New York
United States	Regeneron Study Site	New York	New York
United States	Regeneron Study Site	New York	New York
United States	Regeneron Study Site	Newburgh	Indiana
United States	Regeneron Study Site	Newnan	Georgia
United States	Regeneron Study Site	Newport News	Virginia
United States	Regeneron Study Site	Norfolk	Virginia
United States	Regeneron Study Site	Normal	Illinois
United States	Regeneron Study Site	Norman	Oklahoma
United States	Regeneron Study Site	Oceanside	California
United States	Regeneron Study Site	Orange	California
United States	Regeneron Study Site	Orlando	Florida
United States	Regeneron Study Site	Overland Park	Kansas
United States	Regeneron Study Site	Philadelphia	Pennsylvania
United States	Regeneron Study Site 1	Phoenix	Arizona
United States	Regeneron Study Site 2	Phoenix	Arizona
United States	Regeneron Study Site 3	Phoenix	Arizona
United States	Regeneron Study Site	Pittsburgh	Pennsylvania
United States	Regeneron Study Site	Plainfield	Indiana
United States	Regeneron Study Site	Plymouth	Minnesota
United States	Regeneron Study Site	Portland	Oregon
United States	Regeneron Study Site	Portland	Oregon
United States	Regeneron Study Site	Portsmouth	New Hampshire
United States	Regeneron Study Site	Raleigh	North Carolina
United States	Regeneron Study Site	Richmond	Virginia
United States	Regeneron Study Site	Rochester	New York
United States	Regeneron Study Site	Rockville	Maryland
United States	Regeneron Study Site	Rogers	Arkansas
United States	Regeneron Study Site	Rolling Hills Estates	California
United States	Regeneron Study Site	Saint Joseph	Missouri
United States	Regeneron Study Site	Saint Louis	Missouri
United States	Regeneron Study Site	Saint Louis	Missouri
United States	Regeneron Study Site	Salt Lake City	Utah
United States	Regeneron Study Site	San Antonio	Texas
United States	Regeneron Study Site	San Antonio	Texas
United States	Regeneron Study Site 1	San Antonio	Texas
United States	Regeneron Study Site 2	San Antonio	Texas
United States	Regeneron Study Site	San Diego	California
United States	Regeneron Study Site 1	San Diego	California
United States	Regeneron Study Site 2	San Diego	California
United States	Regeneron Study Site	Sandy Springs	Georgia
United States	Regeneron Study Site	Santa Monica	California
United States	Regeneron Study Site	Savannah	Georgia
United States	Regeneron Study Site	Seattle	Washington
United States	Regeneron Study Site	South Burlington	Vermont
United States	Regeneron Study Site	Tampa	Florida
United States	Regeneron Study Site	Tampa	Florida
United States	Regeneron Study Site	Tampa	Florida
United States	Regeneron Study Site	Troy	Michigan
United States	Regeneron Study Site	Trumbull	Connecticut
United States	Regeneron Study Site	Tulsa	Oklahoma
United States	Regeneron Study Site	Verona	New Jersey
United States	Regeneron Study Site	Waco	Texas
United States	Regeneron Study Site	Washington	District of Columbia
United States	Regeneron Study Site	Webster	Texas
United States	Regeneron Study Site	West Dundee	Illinois
United States	Regeneron Study Site	West Palm Beach	Florida
United States	Regeneron Study Site	Wilmington	North Carolina
United States	Regeneron Study Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  China,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Hungary,  Ireland,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Netherlands,  New Zealand,  Poland,  Romania,  Russian Federation,  Singapore,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Treatment Emergent Adverse Events (TEAEs)		Up to 272 weeks
Primary	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)	Up to 24 Weeks
Secondary	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)	Up to 272 weeks
Secondary	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)	Up to 272 weeks
Secondary	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)	Up to 272 weeks
Secondary	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.	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)
Secondary	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.	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)"
Secondary	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]	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)"
Secondary	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.	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)"
Secondary	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.	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)"
Secondary	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	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)"
Secondary	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	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)"
Secondary	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	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)"
Secondary	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	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)"
Secondary	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	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)"
Secondary	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	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)"
Secondary	Percentage of Participants Requiring Rescue Treatment: Overall		Up to 272 weeks
Secondary	Percentage of Participants Requiring Rescue Treatment: Systemic Treatment		Up to 272 weeks
Secondary	Percentage of Participants Requiring Rescue Treatment: Phototherapy		Up to 272 weeks
Secondary	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	Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
Secondary	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.	Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
Secondary	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).	Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"
Secondary	OPTIONAL SUB-STUDY: Ctrough of Functional Dupilumab in Serum Before and After Switching to the New Dupilumab Drug Product		Up to week 12
Secondary	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.	Up to 24 Weeks