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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 9, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief 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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2678 participants
Allocation: N/A
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 : May 8, 2022
Estimated Study Completion Date : May 8, 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: Up to 5 Years ]
    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: Up to 5 Years ]
    Incidence and rate (events per patient-year) of SAEs of special interest

  2. Number of Adverse Events (AEs) of special interest [ Time Frame: Up to 5 Years ]
    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: Up to 5 Years ]
    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: Up to 5 Years ]
  5. Proportion of patients with low disease activity state (eg, IGA ≤2) at each visit [ Time Frame: Up to 5 Years ]
  6. Change from baseline in EASI score at each visit [ Time Frame: Up to 5 Years ]
  7. Percent change from baseline in EASI score at each visit [ Time Frame: Up to 5 Years ]
  8. Proportion of patients with EASI-50 (≥50% reduction in EASI scores from baseline of the parent study) at each visit [ Time Frame: Up to 5 Years ]
  9. Proportion of patients with EASI-90 (≥90% reduction in EASI scores from baseline of the parent study) at each visit [ Time Frame: Up to 5 Years ]
  10. Change from baseline in Pruritus Numerical Rating Scale (NRS) [ Time Frame: Up to 5 Years ]
    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: Up to 5 Years ]
    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: Up to 5 Years ]
  13. Proportion of patients with improvement (reduction) of Pruritus NRS ≥4 from baseline [ Time Frame: Up to 5 Years ]
  14. Time to first remission (achieving IGA = 0 or 1) [ Time Frame: Up to 5 Years ]
  15. Time to first relapse (eg, IGA >2) after remission or to not achieving remission [ Time Frame: Up to 5 Years ]
  16. Time to first EASI-50/75/90 [ Time Frame: Up to 5 Years ]
  17. Proportion of patients requiring rescue treatment: Overall [ Time Frame: Up to 5 Years ]
  18. Proportion of patients requiring rescue treatment: Systemic treatment [ Time Frame: Up to 5 Years ]
  19. Proportion of patients requiring rescue treatment: Phototherapy [ Time Frame: Up to 5 Years ]
  20. Number of days on topical medication (per patient-year) [ Time Frame: Up to 5 Years ]
  21. Proportion of patients using topical medications over various periods during the study [ Time Frame: Up to 5 Years ]
  22. Changes from baseline to prespecified time points through the end of the study: Dermatology Life Quality Index (DLQI) [ Time Frame: Up to 5 Years ]
    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: Up to 5 Years ]
    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: Up to 5 Years ]
    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.


Layout table for eligibility information
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


Locations
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United States, Alabama
Regeneron Study Site
Anniston, Alabama, United States, 36207
Regeneron Study Site
Birmingham, Alabama, United States, 35205
Regeneron Study Site 1
Birmingham, Alabama, United States, 35209
Regeneron Study Site 2
Birmingham, Alabama, United States, 35233
United States, Arizona
Regeneron Study Site 2
Phoenix, Arizona, United States, 85018
Regeneron Study Site 3
Phoenix, Arizona, United States, 85023
Regeneron Study Site 1
Phoenix, Arizona, United States, 85032
United States, Arkansas
Regeneron Study Site
Fort Smith, Arkansas, United States, 72916
Regeneron Study Site
Rogers, Arkansas, United States, 72758
United States, California
Regeneron Study Site
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 1
Los Angeles, California, United States, 90025
Regeneron Study Site 2
Los Angeles, California, United States, 90025
Regeneron Study Site
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 1
San Diego, California, United States, 92123
Regeneron Study Site 2
San Diego, California, United States, 92123
Regeneron Study Site
Santa Monica, California, United States, 90404
United States, Colorado
Regeneron Study Site
Centennial, Colorado, United States, 80112
Regeneron Study Site
Denver, Colorado, United States, 80206
Regeneron Study Site
Denver, Colorado, United States, 80220
United States, Connecticut
Regeneron Study Site
Trumbull, Connecticut, United States, 06611
United States, District of Columbia
Regeneron Study Site
Washington, District of Columbia, United States, 20037
United States, Florida
Regeneron Study Site
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 1
Jacksonville, Florida, United States, 32216
Regeneron Study Site 2
Jacksonville, Florida, United States, 32216
Regeneron Study Site
Lake Worth, Florida, United States, 33461
Regeneron Study Site
Miami Lakes, Florida, United States, 33016
Regeneron Study Site
Miami, Florida, United States, 33135
Regeneron Study Site
Miami, Florida, United States, 33144
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
United States, Georgia
Regeneron Study Site
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
United States, Illinois
Regeneron Study Site
Chicago, Illinois, United States, 60611
Regeneron Study Site
Normal, Illinois, United States, 61761
Regeneron Study Site
West Dundee, Illinois, United States, 60118
United States, Indiana
Regeneron Study Site
Indianapolis, Indiana, United States, 46250
Regeneron Study Site
Newburgh, Indiana, United States, 47630
Regeneron Study Site
Plainfield, Indiana, United States, 46168
United States, Kansas
Regeneron Study Site
Overland Park, Kansas, United States, 66215
United States, Louisiana
Regeneron Study Site
New Orleans, Louisiana, United States, 70112
United States, Maryland
Regeneron Study Site
Rockville, Maryland, United States, 20850
United States, Massachusetts
Regeneron Study Site
Boston, Massachusetts, United States, 02111
Regeneron Study Site
Boston, Massachusetts, United States, 02114
Regeneron Study Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Regeneron Study Site
Bay City, Michigan, United States, 48706
Regeneron Study Site
Farmington Hills, Michigan, United States, 48334
Regeneron Study Site
Troy, Michigan, United States, 48084
United States, Minnesota
Regeneron Study Site
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
United States, Missouri
Regeneron Study Site
Saint Joseph, Missouri, United States, 64506
Regeneron Study Site
Saint Louis, Missouri, United States, 63104
Regeneron Study Site
Saint Louis, Missouri, United States, 63141
United States, Nevada
Regeneron Study Site
Henderson, Nevada, United States, 89052
Regeneron Study Site
Las Vegas, Nevada, United States, 89119
United States, New Hampshire
Regeneron Study Site
Portsmouth, New Hampshire, United States, 03801
United States, New Jersey
Regeneron Study Site
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
United States, New Mexico
Regeneron Study Site 1
Albuquerque, New Mexico, United States, 87106
Regeneron Study Site 2
Albuquerque, New Mexico, United States, 87106
United States, New York
Regeneron Study Site
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, 10021
Regeneron Study Site
New York, New York, United States, 10029-6501
Regeneron Study Site
New York, New York, United States, 10075
Regeneron Study Site
Rochester, New York, United States, 14642
United States, North Carolina
Regeneron Study Site
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
United States, Ohio
Regeneron Study Site
Cincinnati, Ohio, United States, 45231
Regeneron Study Site
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Regeneron Study Site
Norman, Oklahoma, United States, 73071
Regeneron Study Site
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Regeneron Study Site
Medford, Oregon, United States, 97504-9741
Regeneron Study Site
Portland, Oregon, United States, 97223
Regeneron Study Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Regeneron Study Site
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
United States, South Carolina
Regeneron Study Site
Charleston, South Carolina, United States, 29407
Regeneron Study Site
Greer, South Carolina, United States, 29650
United States, Tennessee
Regeneron Study Site
Chattanooga, Tennessee, United States, 37421
Regeneron Study Site
Nashville, Tennessee, United States, 37215
United States, Texas
Regeneron Study Site
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, 75230
Regeneron Study Site
Dallas, Texas, United States, 75231
Regeneron Study Site
Dallas, Texas, United States, 75246
Regeneron Study Site
Houston, Texas, United States, 77004
Regeneron Study Site
San Antonio, Texas, United States, 78218
Regeneron Study Site 1
San Antonio, Texas, United States, 78229
Regeneron Study Site 2
San Antonio, Texas, United States, 78229
Regeneron Study Site
San Antonio, Texas, United States, 78258
Regeneron Study Site
Waco, Texas, United States, 76710
Regeneron Study Site
Webster, Texas, United States, 77598
United States, Utah
Regeneron Study Site
Salt Lake City, Utah, United States, 84132
United States, Vermont
Regeneron Study Site
South Burlington, Vermont, United States, 05403
United States, Virginia
Regeneron Study Site
Newport News, Virginia, United States, 23606-4537
Regeneron Study Site
Norfolk, Virginia, United States, 23502
Regeneron Study Site
Richmond, Virginia, United States, 23220
United States, Washington
Regeneron Study Site
Seattle, Washington, United States, 98101
Australia, Australian Capital Territory
Regeneron Study Site
Phillip, Australian Capital Territory, Australia
Australia, New South Wales
Regeneron Study Site
Kogarah, New South Wales, Australia
Australia, Queensland
Regeneron Study Site
Benowa, Queensland, Australia
Regeneron Study Site
Woolloongabba, Queensland, Australia
Australia, South Australia
Regeneron Study Site
Hectorville, South Australia, Australia
Australia, Victoria
Regeneron Study Site
Carlton, Victoria, Australia
Regeneron Study Site
East Melbourne, Victoria, Australia
Australia, Western Australia
Regeneron Study Site
Fremantle, Western Australia, Australia
Austria
Regeneron Study Site 1
Wien, Austria
Regeneron Study Site 2
Wien, Austria
Belgium
Regeneron Study Site
Bruxelles, Brussels Capital Region, Belgium
Regeneron Study Site
Loverval, Hainaut, Belgium
Regeneron Study Site
Leuven, Vlaams Brabant, Belgium
Bulgaria
Regeneron Study Site
Dupnitsa, Kjustendil, Bulgaria
Regeneron Study Site 1
Sofia, Sofia-Grad, Bulgaria
Regeneron Study Site 2
Sofia, Sofia-Grad, Bulgaria
Canada, Alberta
Regeneron Study Site 1
Calgary, Alberta, Canada
Regeneron Study Site 2
Calgary, Alberta, Canada
Regeneron Study Site 1
Edmonton, Alberta, Canada
Regeneron Study Site 2
Edmonton, Alberta, Canada
Canada, British Columbia
Regeneron Study Site 1
Surrey, British Columbia, Canada
Regeneron Study Site 2
Surrey, British Columbia, 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
Canada, Manitoba
Regeneron Study Site 1
Winnipeg, Manitoba, Canada
Canada, New Brunswick
Regeneron Study Site
Bathurst, New Brunswick, Canada
Canada, Newfoundland and Labrador
Regeneron Study Site
St. John's, Newfoundland and Labrador, Canada
Canada, Ontario
Regeneron Study Site
Ajax, Ontario, Canada
Regeneron Study Site 1
Barrie, Ontario, Canada
Regeneron Study Site 2
Barrie, Ontario, 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
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
Toronto, Ontario, Canada
Regeneron Study Site
Waterloo, Ontario, Canada
Regeneron Study Site 1
Windsor, Ontario, Canada
Regeneron Study Site 2
Windsor, Ontario, Canada
Canada, Quebec
Regeneron Study Site
Drummondville, Quebec, Canada
Regeneron Study Site
Montreal, Quebec, Canada
Regeneron Study Site 3
Ste-Foy, Quebec, Canada
Canada
Regeneron Study Site
Ste-Foy, Canada
Regeneron Study Site
Winnipeg, Canada
China
Regeneron Study Site
Hong Kong, China
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, Czechia
Denmark
Regeneron Study Site
Copenhagen, Capital, Denmark
Regeneron Study Site
Hellerup, Capital, Denmark
Regeneron Study Site
Aarhus, Central Jutland, Denmark
Regeneron Study Site
Roskilde, Zeeland, Denmark
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, Estonia
Finland
Regeneron Study Site
Helsinki, Etelä-Suomen Iääni, Finland
Regeneron Study Site
Turku, Etelä-Suomen Lääni, Finland
Regeneron Study Site
Tampere, Länsi-Suomen Lääni, Finland
France
Regeneron Study Site
Nice Cedex 3, Alpes-Maritimes, France
Regeneron Study Site
Marseille, Bouches-du-Rhône, France
Regeneron Study Site
Reims, Marne, France
Regeneron Study Site
Lille, Nord, France
Regeneron Study Site
Pierre Benite, Rhône-Alpes, France
Regeneron Study Site
Lille cedex, France
Regeneron Study Site
Nantes, France
Regeneron Study Site
Paris, Île-de-France, France
Germany
Regeneron Study Site
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
Augsburg, Bayern, Germany
Regeneron Study Site
Erlangen, Bayern, Germany
Regeneron Study Site
Munchen, Bayern, Germany
Regeneron Study Site
Munich, Bayern, Germany
Regeneron Study Site
Mahlow, Brandenburg, Germany
Regeneron Study Site 2
Hamburg, Hamburgh, Germany
Regeneron Study Site
Frankfurt/Main, Hessen, Germany
Regeneron Study Site
Schwerin, Mecklenburg-Vorpommern, Germany
Regeneron Study Site
Hannover, Niedersachsen, Germany
Regeneron Study Site 1
Bochum, Nordrhein-Westfalen, Germany
Regeneron Study Site 2
Bochum, Nordrhein-Westfalen, Germany
Regeneron Study Site
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
Mainz, Rheinland-Pfalz, Germany
Regeneron Study Site
Selters, Rheinland-Pfalz, Germany
Regeneron Study Site
Halle, Sachsen-Anhalt, Germany
Regeneron Study Site
Magdeburg, Sachsen-Anhalt, 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
Leipzig, Sachsen, Germany
Regeneron Study Site 1
Kiel, Schleswig-Holstein, Germany
Regeneron Study Site 2
Kiel, Schleswig-Holstein, Germany
Regeneron Study Site
Lubeck, Schleswig-Holstein, Germany
Regeneron Study Site
Gera, Thüringen, 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
Bonn, Germany
Regeneron Study Site
Darmstadt, Germany
Regeneron Study Site 1
Hamburg, Germany
Regeneron Study Site
Münster, Germany
Regeneron Study Site
Osnabrück, Germany
Hungary
Regeneron Study Site
Sátoraljaújhely, Borsod-Abaúj-Zemplén, Hungary
Regeneron Study Site
Oroshaza, Békés, Hungary
Regeneron Study Site
Szeged, Csongrád, Hungary
Regeneron Study Site
Szolnok, Jász-Nagykun-Szolnok, Hungary
Regeneron Study Site
Kaposvár, Somogy, Hungary
Regeneron Study Site 1
Budapest, Hungary
Regeneron Study Site 2
Budapest, Hungary
Regeneron Study Site 3
Budapest, Hungary
Regeneron Study Site
Veszprem, Hungary
Ireland
Regeneron Study Site
Dublin, Ireland
Italy
Regeneron Study Site
Bologna, Balogna, Italy
Regeneron Study Site
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 1
Roma, Italy
Regeneron Study Site 2
Roma, Italy
Japan
Regeneron Study Site
Nagakute, Aichi, Japan
Regeneron Study Site
Kurume, Fukuoka, Japan
Regeneron Study Site
Fukuyama, Hiroshima, Japan
Regeneron Study Site
Sapporo, Hokkaido, Japan
Regeneron Study Site 1
Fukuoka, Hukuoka, Japan
Regeneron Study Site 2
Fukuoka, Hukuoka, Japan
Regeneron Study Site
Kitakyushu, Hukuoka, Japan
Regeneron Study Site 1
Amagasaki, Hyôgo, Japan
Regeneron Study Site 2
Amagasaki, Hyôgo, Japan
Regeneron Study Site
Inashiki-gun, Ibaraki, 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
Kamimashiki, Kumamoto, Japan
Regeneron Study Site
Habikino, Osaka, Japan
Regeneron Study Site
Neyagawa, Osaka, Japan
Regeneron Study Site
Sakai, Osaka, Japan
Regeneron Study Site
Takatsuki, Osaka, Japan
Regeneron Study Site
Hamamatsu, Shizuoka, Japan
Regeneron Study Site
Yaizu, Shizuoka, Japan
Regeneron Study Site
Chuo-ku, Tokyo,, 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
Koto-ku, Tokyo, 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
Ota-ku, Tokyo, 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 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
Kofu, Yamanashi, Japan
Regeneron Study Site
Chuo, Yamanasi, Japan
Regeneron Study Site 2
Fukuyama, Japan
Regeneron Study Site
Gifu, Japan
Regeneron Study Site 1
Hiroshima, Japan
Regeneron Study Site 2
Hiroshima, Japan
Regeneron Study Site 1
Kyoto, Japan
Regeneron Study Site 2
Kyoto, Japan
Regeneron Study Site 1
Osaka, Japan
Regeneron Study Site 2
Osaka, Japan
Regeneron Study Site
Saitama, Japan
Regeneron Study Site 3
Shinagawa-ku, Japan
Regeneron Study Site
Suginome, Japan
Regeneron Study Site
Wakayama, Japan
Regeneron Study Site 4
Yokohama, Japan
Korea, Republic of
Regeneron Study Site
Busan, Busan Gwang'yeogsi, Korea, Republic of
Regeneron Study Site
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 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
Lithuania
Regeneron Study Site
Kaunas, Kauno Apskritis, Lithuania
Regeneron Study Site 1
Vilnius, Vilniaus Apskritis, Lithuania
Regeneron Study Site 2
Vilnius, Vilniaus Apskritis, Lithuania
Regeneron Study Site 1
Klaipeda, Lithuania
Regeneron Study Site 2
Klaipeda, Lithuania
Netherlands
Regeneron Study Site
Breda, Noord-Brabant, Netherlands
Regeneron Study Site
Amsterdam, Noord-Holland, Netherlands
Regeneron Study Site
Rotterdam, Zuid-Holland, Netherlands
Regeneron Study Site
Groningen, Netherlands
Regeneron Study Site
Utrecht, Netherlands
New Zealand
Regeneron Study Site
Dunedin, South Island, New Zealand
Regeneron Study Site
Auckland, New Zealand
Poland
Regeneron Study Site 1
Wroclaw, Dolnośląskie, Poland
Regeneron Study Site 2
Wroclaw, Dolnośląskie, Poland
Regeneron Study Site 3
Wroclaw, Dolnośląskie, Poland
Regeneron Study Site
Torun, Kujawsko-pomorskie, 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 1
Krakow, Malopolskie, Poland
Regeneron Study Site 2
Krakow, Malopolskie, Poland
Regeneron Study Site 3
Krakow, Malopolskie, 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
Strzelce Opolskie, Opolskie, Poland
Regeneron Study Site
Iwonicz Zdroj, Podkarpackie, Poland
Regeneron Study Site 1
Gdansk, Pomorskie, Poland
Regeneron Study Site 2
Gdansk, Pomorskie, 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
Szczecin, Zachodniopomorskie, Poland
Regeneron Study Site
Bialystok, Poland
Regeneron Study Site
Bydgoszcz, Poland
Regeneron Study Site
Chorzow, Poland
Regeneron Study Site
Elblag, Poland, 82300
Regeneron Study Site 1
Katowice, Poland
Regeneron Study Site 2
Katowice, Poland
Regeneron Study Site 3
Katowice, Poland
Regeneron Study Site
Ostrowiec Swietokrzyski, Poland
Regeneron Study Site
Skarzysko-Kamienna, Poland
Regeneron Study Site
Zgierz, Poland, 95100
Romania
Regeneron Study Site
Brasov, Romania
Russian Federation
Regeneron Study Site
Moscow, Koskva, Russian Federation
Regeneron Study Site
Ryazan, Ryazanskaya Oblast', Russian Federation
Regeneron Study Site
Saint Petersburg, Sankt-Peterburg, Russian Federation
Regeneron Study Site
Kazan, Tatarstan Respublika, Russian Federation
Regeneron Study Site
Chelyabinsk, Russian Federation
Singapore
Regeneron Study Site 1
Singapore, Central Singapore, Singapore
Regeneron Study Site 2
Singapore, Central Singapore, Singapore
Regeneron Study Site
Singapore, South West, Singapore
Slovakia
Regeneron Study Site
Kosice, Slovakia
Regeneron Study Site
Svidnik, Slovakia
Spain
Regeneron Study Site
Elche, Alicante, Spain
Regeneron Study Site
Badalona, Barcelona, Spain
Regeneron Study Site
Las Palmas de Gran Canaria, Canarias, 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 1
Madrid, Spain
Regeneron Study Site 2
Madrid, Spain
Regeneron Study Site
Sevilla, Spain
United Kingdom
Regeneron Study Site
Dundee, Angus, United Kingdom
Regeneron Study Site
Edgbaston, Birmingham, United Kingdom
Regeneron Study Site
Plymouth, Devon, United Kingdom
Regeneron Study Site
Portsmouth, Hampshire, United Kingdom
Regeneron Study Site
Sidcup, Kent, United Kingdom
Regeneron Study Site
Northwood, London, United Kingdom
Regeneron Study Site
Oxford, Oxfordshire, 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
Salford, United Kingdom
Regeneron Study Site
Sheffield, United Kingdom
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01949311    
Other Study ID Numbers: R668-AD-1225
2013-001449-15 ( EudraCT Number )
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: May 2020

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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