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Open-label Study of Dupilumab in Patients With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01949311
Recruitment Status : Active, not recruiting
First Posted : September 24, 2013
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
This is an open label extension study for patients who participated in placebo-controlled dupilumab atopic dermatitis (AD) trials. The study primarily evaluates long term safety (adverse events) and immunogenicity. Efficacy parameters are based on Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI) and the Pruritus Numerical Rating Scale (NRS).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Dupilumab Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2678 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials
Actual Study Start Date : October 10, 2013
Estimated Primary Completion Date : April 6, 2022
Estimated Study Completion Date : April 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab

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




Primary Outcome Measures :
  1. Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to week 160 ]
    The primary endpoint in the study is the incidence and rate (events per patient-year) of TEAEs through the last study visit.


Secondary Outcome Measures :
  1. Number of Serious Adverse Events (SAEs) of special interest [ Time Frame: Day 1 to week 160 ]
    Incidence and rate (events per patient-year) of SAEs of special interest

  2. Number of Adverse Events (AEs) of special interest [ Time Frame: Day 1 to week 160 ]
    Incidence and rate (events per patient-year) of AEs of special interest

  3. Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit [ Time Frame: Day 1 to week 160 ]
    Proportion of patients who achieve and maintain a score of 0 to 1 on the IGA scale [(a 6-point scale ranging from 0 (clear) to 5 (very severe)]

  4. Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75% reduction in EASI scores from baseline of the parent study) at each visit [ Time Frame: Day 1 to week 160 ]
  5. Proportion of patients with low disease activity state (eg, IGA ≤2) at each visit [ Time Frame: Day 1 to week 160 ]
  6. Change from baseline in EASI score at each visit [ Time Frame: Day 1 to week 160 ]
  7. Percent change from baseline in EASI score at each visit [ Time Frame: Day 1 to week 160 ]
  8. Proportion of patients with EASI-50 (≥50% reduction in EASI scores from baseline of the parent study) at each visit [ Time Frame: Day 1 to week 160 ]
  9. Proportion of patients with EASI-90 (≥90% reduction in EASI scores from baseline of the parent study) at each visit [ Time Frame: Day 1 to week 160 ]
  10. Change from baseline in Pruritus Numerical Rating Scale (NRS) [ Time Frame: Day 1 to week 160 ]
    The Pruritus NRS is a simple assessment tool that patients will use to report the average intensity of their pruritus (itch), during a 1-week recall period.

  11. Percent change from baseline in Pruritus NRS [ Time Frame: Day 1 to week 160 ]
    The Pruritus NRS is a simple assessment tool that patients will use to report the average intensity of their pruritus (itch), during a 1-week recall period.

  12. Proportion of patients with improvement (reduction) of Pruritus NRS ≥3 from baseline [ Time Frame: Day 1 to week 160 ]
  13. Proportion of patients with improvement (reduction) of Pruritus NRS ≥4 from baseline [ Time Frame: Day 1 to week 160 ]
  14. Time to first remission (achieving IGA = 0 or 1) [ Time Frame: Day 1 to week 160 ]
  15. Time to first relapse (eg, IGA >2) after remission or to not achieving remission [ Time Frame: Day 1 to week 160 ]
  16. Time to first EASI-50/75/90 [ Time Frame: Day 1 to week 160 ]
  17. Proportion of patients requiring rescue treatment: Overall [ Time Frame: Day 1 to week 160 ]
  18. Proportion of patients requiring rescue treatment: Systemic treatment [ Time Frame: Day 1 to week 160 ]
  19. Proportion of patients requiring rescue treatment: Phototherapy [ Time Frame: Day 1 to week 160 ]
  20. Number of days on topical medication (per patient-year) [ Time Frame: Day 1 to week 160 ]
  21. Proportion of patients using topical medications over various periods during the study [ Time Frame: Day 1 to week 160 ]
  22. Changes from baseline to prespecified time points through the end of the study: Dermatology Life Quality Index (DLQI) [ Time Frame: Day 1 to week 160 ]
    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) (Badia 1999). 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.

  23. Changes from baseline to prespecified time points through the end of the study: Patient Oriented Eczema Measure (POEM) [ Time Frame: Day 1 to week 160 ]
    The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults (Charman 2004). 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.

  24. Changes from baseline to prespecified time points through the end of the study: EuroQol-5D (EQ-5D) [ Time Frame: Day 1 to week 160 ]
    The EQ-5D as a measure of health-related QOL, defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 ordinal levels of severity: "no problem" (1), "some problems" (2), "severe problems" (3). Overall health state is defined as a 5-digit number.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949311


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

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01949311     History of Changes
Other Study ID Numbers: R668-AD-1225
2013-001449-15 ( EudraCT Number )
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs