Open-label Study of Dupilumab in Patients With Atopic Dermatitis
An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials
2 other identifiers
interventional
2,733
26 countries
419
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2013
Longer than P75 for phase_3
419 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2013
CompletedFirst Posted
Study publicly available on registry
September 24, 2013
CompletedStudy Start
First participant enrolled
October 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2022
CompletedResults Posted
Study results publicly available
October 17, 2023
CompletedOctober 17, 2023
October 1, 2023
8.7 years
September 20, 2013
June 23, 2023
October 16, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Treatment Emergent Adverse Events (TEAEs)
Up to 272 weeks
OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product
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 Outcomes (22)
Number of Serious Adverse Events (SAEs) of Special Interest
Up to 272 weeks
Rate of AESIs
Up to 272 weeks
Number of AESIs
Up to 272 weeks
Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit
Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)
Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit
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)"
- +17 more secondary outcomes
Study Arms (1)
Dupilumab
EXPERIMENTALParticipants will receive repeat doses of dupilumab
Interventions
Eligibility Criteria
You may qualify if:
- Participation in a prior clinical trial of dupilumab for AD and met one of the following:
- Received study treatment and adequately completed the assessments required for both the treatment and follow-up periods of the parent studies (except studies listed in b) as defined in the parent protocols
- Received study treatment in one the studies that have completed last patient, last visit irrespective of duration of participation, provided that patients completed with the instructions received during the study.
- Underwent screening in R668-AD-1334 (Liberty AD SOLO 1) or R668-AD-1416 (Liberty AD SOLO 2) but could not be randomized due to randomization closure.
- Willing and able to comply with all clinic visits and study-related procedures
- Able to understand and complete study-related questionnaires
- Provide signed informed consent
- Optional Sub-Study:
- Provide separate informed consent
- Continuing in the treatment period of the main OLE study
- Demonstrated compliance with dupilumab therapy, as defined in the protocol
You may not qualify if:
- Patients who, during their participation in a previous dupilumab clinical trial, developed a serious adverse event (SAE) deemed related to dupilumab\*, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
- Patients who, during their participation in a previous dupilumab clinical trial, developed an AE that was deemed related to dupilumab\* and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
- Conditions in the previous dupilumab study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to dupilumab\* or led to investigator - or sponsor-initiated withdrawal of patient from the study (eg, non-compliance, inability to complete study assessments, etc.).
- Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
- Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the patient's participation in this study
- Optional Sub-Study:
- \. Patients who have already completed the end of treatment visit (ie, visit 44) for the main study R668-AD-1225
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Sanoficollaborator
Study Sites (432)
Regeneron Study Site
Anniston, Alabama, 36207, United States
Regeneron Study Site
Birmingham, Alabama, 35205, United States
Regeneron Study Site 1
Birmingham, Alabama, 35209, United States
Regeneron Study Site 2
Birmingham, Alabama, 35233, United States
Regeneron Study Site 2
Phoenix, Arizona, 85018, United States
Regeneron Study Site 3
Phoenix, Arizona, 85023, United States
Regeneron Study Site 1
Phoenix, Arizona, 85032, United States
Regeneron Study Site
Fort Smith, Arkansas, 72916, United States
Regeneron Study Site
Rogers, Arkansas, 72758, United States
Regeneron Study Site
Bakersfield, California, 93309, United States
Regeneron Study Site
Clovis, California, 93612, United States
Regeneron Study Site
Costa Mesa, California, 92626, United States
Regeneron Study Site
Encinitas, California, 92024, United States
Regeneron Study Site
Fremont, California, 94538, United States
Regeneron Study Site
Lomita, California, 90717, United States
Regeneron Study Site
Long Beach, California, 90808, United States
Regeneron Study Site 1
Los Angeles, California, 90025, United States
Regeneron Study Site 2
Los Angeles, California, 90025, United States
Regeneron Study Site
Los Angeles, California, 90045, United States
Regeneron Study Site
Oceanside, California, 92056, United States
Regeneron Study Site
Orange, California, 92868, United States
Regeneron Study Site
Rolling Hills Estates, California, 90274, United States
Regeneron Study Site
San Diego, California, 92122, United States
Regeneron Study Site 1
San Diego, California, 92123, United States
Regeneron Study Site 2
San Diego, California, 92123, United States
Regeneron Study Site
Santa Monica, California, 90404, United States
Regeneron Study Site
Centennial, Colorado, 80112, United States
Regeneron Study Site
Denver, Colorado, 80206, United States
Regeneron Study Site
Denver, Colorado, 80220, United States
Regeneron Study Site
Trumbull, Connecticut, 06611, United States
Regeneron Study Site
Washington D.C., District of Columbia, 20037, United States
Regeneron Study Site
Boca Raton, Florida, 33486, United States
Regeneron Study Site
Clearwater, Florida, 33756, United States
Regeneron Study Site
Fort Lauderdale, Florida, 33306, United States
Regeneron Study Site 1
Jacksonville, Florida, 32216, United States
Regeneron Study Site 2
Jacksonville, Florida, 32216, United States
Regeneron Study Site
Lake Worth, Florida, 33461, United States
Regeneron Study Site
Miami, Florida, 33135, United States
Regeneron Study Site
Miami, Florida, 33144, United States
Regeneron Study Site
Miami Lakes, Florida, 33016, United States
Regeneron Study Site
Orlando, Florida, 32806, United States
Regeneron Study Site
Tampa, Florida, 33607, United States
Regeneron Study Site
Tampa, Florida, 33614, United States
Regeneron Study Site
Tampa, Florida, 33624, United States
Regeneron Study Site
West Palm Beach, Florida, 33406, United States
Regeneron Study Site
Alpharetta, Georgia, 30022, United States
Regeneron Study Site
Atlanta, Georgia, 30322, United States
Regeneron Study Site
Columbus, Georgia, 31904, United States
Regeneron Study Site
Macon, Georgia, 31217, United States
Regeneron Study Site
Newnan, Georgia, 30263, United States
Regeneron Study Site
Sandy Springs, Georgia, 30328, United States
Regeneron Study Site
Savannah, Georgia, 31405, United States
Regeneron Study Site
Chicago, Illinois, 60611, United States
Regeneron Study Site
Normal, Illinois, 61761, United States
Regeneron Study Site
West Dundee, Illinois, 60118, United States
Regeneron Study Site
Indianapolis, Indiana, 46250, United States
Regeneron Study Site
Newburgh, Indiana, 47630, United States
Regeneron Study Site
Plainfield, Indiana, 46168, United States
Regeneron Study Site
Overland Park, Kansas, 66215, United States
Regeneron Study Site
New Orleans, Louisiana, 70112, United States
Regeneron Study Site
Rockville, Maryland, 20850, United States
Regeneron Study Site
Boston, Massachusetts, 02111, United States
Regeneron Study Site
Boston, Massachusetts, 02114, United States
Regeneron Study Site
Boston, Massachusetts, 02115, United States
Regeneron Study Site
Bay City, Michigan, 48706, United States
Regeneron Study Site
Farmington Hills, Michigan, 48334, United States
Regeneron Study Site
Troy, Michigan, 48084, United States
Regeneron Study Site
Edina, Minnesota, 55435, United States
Regeneron Study Site
Fridley, Minnesota, 55432, United States
Regeneron Study Site
Minneapolis, Minnesota, 55402, United States
Regeneron Study Site
Plymouth, Minnesota, 55402, United States
Regeneron Study Site
Saint Joseph, Missouri, 64506, United States
Regeneron Study Site
St Louis, Missouri, 63104, United States
Regeneron Study Site
St Louis, Missouri, 63141, United States
Regeneron Study Site
Henderson, Nevada, 89052, United States
Regeneron Study Site
Las Vegas, Nevada, 89119, United States
Regeneron Study Site
Portsmouth, New Hampshire, 03801, United States
Regeneron Study Site
Berlin, New Jersey, 08009, United States
Regeneron Study Site
East Windsor, New Jersey, 08520, United States
Regeneron Study Site
Verona, New Jersey, 07044-2946, United States
Regeneron Study Site 1
Albuquerque, New Mexico, 87106, United States
Regeneron Study Site 2
Albuquerque, New Mexico, 87106, United States
Regeneron Study Site
Buffalo, New York, 14203, United States
Regeneron Study Site
Corning, New York, 14830, United States
Regeneron Study Site
Forest Hills, New York, 11375, United States
Regeneron Study Site
New York, New York, 10016, United States
Regeneron Study Site
New York, New York, 10021, United States
Regeneron Study Site
New York, New York, 10029-6501, United States
Regeneron Study Site
New York, New York, 10075, United States
Regeneron Study Site
Rochester, New York, 14642, United States
Regeneron Study Site
Chapel Hill, North Carolina, 27516, United States
Regeneron Study Site
High Point, North Carolina, 27262, United States
Regeneron Study Site
Raleigh, North Carolina, 27612, United States
Regeneron Study Site
Wilmington, North Carolina, 28405, United States
Regeneron Study Site
Winston-Salem, North Carolina, 27104, United States
Regeneron Study Site
Cincinnati, Ohio, 45231, United States
Regeneron Study Site
Cleveland, Ohio, 44106, United States
Regeneron Study Site
Norman, Oklahoma, 73071, United States
Regeneron Study Site
Tulsa, Oklahoma, 74136, United States
Regeneron Study Site
Medford, Oregon, 97504-9741, United States
Regeneron Study Site
Portland, Oregon, 97223, United States
Regeneron Study Site
Portland, Oregon, 97239, United States
Regeneron Study Site
Bethlehem, Pennsylvania, 18020, United States
Regeneron Study Site
Jenkintown, Pennsylvania, 19046, United States
Regeneron Study Site
Philadelphia, Pennsylvania, 19104, United States
Regeneron Study Site
Pittsburgh, Pennsylvania, 15213, United States
Regeneron Study Site
Charleston, South Carolina, 29407, United States
Regeneron Study Site
Greer, South Carolina, 29650, United States
Regeneron Study Site
Chattanooga, Tennessee, 37421, United States
Regeneron Study Site
Nashville, Tennessee, 37215, United States
Regeneron Study Site
Arlington, Texas, 76011, United States
Regeneron Study Site
Austin, Texas, 78705, United States
Regeneron Study Site
Bellaire, Texas, 77401-3505, United States
Regeneron Study Site
Dallas, Texas, 75230, United States
Regeneron Study Site
Dallas, Texas, 75231, United States
Regeneron Study Site
Dallas, Texas, 75246, United States
Regeneron Study Site
Houston, Texas, 77004, United States
Regeneron Study Site
San Antonio, Texas, 78218, United States
Regeneron Study Site 1
San Antonio, Texas, 78229, United States
Regeneron Study Site 2
San Antonio, Texas, 78229, United States
Regeneron Study Site
San Antonio, Texas, 78258, United States
Regeneron Study Site
Waco, Texas, 76710, United States
Regeneron Study Site
Webster, Texas, 77598, United States
Regeneron Study Site
Salt Lake City, Utah, 84132, United States
Regeneron Study Site
South Burlington, Vermont, 05403, United States
Regeneron Study Site
Newport News, Virginia, 23606-4537, United States
Regeneron Study Site
Norfolk, Virginia, 23502, United States
Regeneron Study Site
Richmond, Virginia, 23220, United States
Regeneron Study Site
Seattle, Washington, 98101, United States
Regeneron Study Site
Phillip, Australian Capital Territory, Australia
Regeneron Study Site
Kogarah, New South Wales, Australia
Regeneron Study Site
Benowa, Queensland, Australia
Regeneron Study Site
Woolloongabba, Queensland, Australia
Regeneron Study Site
Hectorville, South Australia, Australia
Regeneron Study Site
Carlton, Victoria, Australia
Regeneron Study Site
East Melbourne, Victoria, Australia
Regeneron Study Site
Fremantle, Western Australia, Australia
Regeneron Study Site 1
Vienna, Austria
Regeneron Study Site 2
Vienna, Austria
Regeneron Study Site
Brussels, Brussels Capital, Belgium
Regeneron Study Site
Loverval, Hainaut, Belgium
Regeneron Study Site
Leuven, Vlaams Brabant, Belgium
Regeneron Study Site
Dupnitsa, Kyustendil, Bulgaria
Regeneron Study Site 1
Sofia, Sofia-Grad, Bulgaria
Regeneron Study Site 2
Sofia, Sofia-Grad, Bulgaria
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
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
Regeneron Study Site 1
Winnipeg, Manitoba, Canada
Regeneron Study Site
Bathurst, New Brunswick, Canada
Regeneron Study Site
St. John's, Newfoundland and Labrador, Canada
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
Regeneron Study Site
Drummondville, Quebec, Canada
Regeneron Study Site
Montreal, Quebec, Canada
Regeneron Study Site 3
Ste-Foy, Quebec, Canada
Regeneron Study Site
Ste-Foy, Canada
Regeneron Study Site
Winnipeg, Canada
Regeneron Study Site
Hong Kong, China
Regeneron Study Site
Hradec Králové, Czechia
Regeneron Study Site
Kutná Hora, Czechia
Regeneron Study Site
Náchod, Czechia
Regeneron Study Site
Prague, Czechia
Regeneron Study Site
Svitavy, Czechia
Regeneron Study Site
Ústí nad Labem, Czechia
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
Regeneron Study Site 1
Tallinn, Harju, Estonia
Regeneron Study Site 2
Tallinn, Harju, Estonia
Regeneron Study Site 3
Tallinn, Harju, Estonia
Regeneron Study Site 1
Tartu, Tartu, Estonia
Regeneron Study Site 2
Tartu, Tartu, Estonia
Regeneron Study Site
Helsinki, Etelä-Suomen Iääni, Finland
Regeneron Study Site
Turku, Etelä-Suomen Lääni, Finland
Regeneron Study Site
Tampere, Länsi-Suomen Lääni, Finland
Regeneron Study Site
Nice, Alpes-Maritimes, France
Regeneron Study Site
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Regeneron Study Site
Marseille, Bouches-du-Rhône, France
Regeneron Study Site
Reims, Marne, France
Regeneron Study Site
Lille, Nord, France
Regeneron Study Site
Lille, France
Regeneron Study Site
Nantes, France
Regeneron Study Site
Paris, Île-de-France Region, France
Regeneron Study Site
Friedrichshafen, Baden-Wurttemberg, Germany
Regeneron Study Site
Heidelberg, Baden-Wurttemberg, Germany
Regeneron Study Site
Langenau, Baden-Wurttemberg, Germany
Regeneron Study Site
Stuttgart, Baden-Wurttemberg, Germany
Regeneron Study Site
Tübingen, Baden-Wurttemberg, Germany
Regeneron Study Site
Augsburg, Bavaria, Germany
Regeneron Study Site
Erlangen, Bavaria, Germany
Regeneron Study Site
Munich, Bavaria, Germany
Regeneron Study Site
München, Bavaria, Germany
Regeneron Study Site
Mahlow, Brandenburg, Germany
Regeneron Study Site 2
Hamburg, Hamburg, Germany
Regeneron Study Site
Frankfurt am Main, Hesse, Germany
Regeneron Study Site
Hanover, Lower Saxony, Germany
Regeneron Study Site
Schwerin, Mecklenburg-Vorpommern, Germany
Regeneron Study Site 1
Bochum, North Rhine-Westphalia, Germany
Regeneron Study Site 2
Bochum, North Rhine-Westphalia, Germany
Regeneron Study Site
Dülmen, North Rhine-Westphalia, Germany
Regeneron Study Site
Ibbenbueren, North Rhine-Westphalia, Germany
Regeneron Study Site
Mönchengladbach, North Rhine-Westphalia, Germany
Regeneron Study Site
Münster, North Rhine-Westphalia, Germany
Regeneron Study Site
Mainz, Rhineland-Palatinate, Germany
Regeneron Study Site
Selters, Rhineland-Palatinate, Germany
Regeneron Study Site 1
Dresden, Saxony, Germany
Regeneron Study Site 2
Dresden, Saxony, Germany
Regeneron Study Site 3
Dresden, Saxony, Germany
Regeneron Study Site
Leipzig, Saxony, Germany
Regeneron Study Site
Halle, Saxony-Anhalt, Germany
Regeneron Study Site
Magdeburg, Saxony-Anhalt, Germany
Regeneron Study Site 1
Kiel, Schleswig-Holstein, Germany
Regeneron Study Site 2
Kiel, Schleswig-Holstein, Germany
Regeneron Study Site
Lübeck, Schleswig-Holstein, Germany
Regeneron Study Site
Gera, Thuringia, 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
Regeneron Study Site
Orosháza, Bekes County, Hungary
Regeneron Study Site
Sátoraljaújhely, Borsod-Abauj Zemplen county, Hungary
Regeneron Study Site
Szeged, Csongrád megye, Hungary
Regeneron Study Site
Szolnok, Jász-Nagykun-Szolnok, Hungary
Regeneron Study Site
Kaposvár, Somogy County, Hungary
Regeneron Study Site 1
Budapest, Hungary
Regeneron Study Site 2
Budapest, Hungary
Regeneron Study Site 3
Budapest, Hungary
Regeneron Study Site
Veszprém, Hungary
Regeneron Study Site
Dublin, Ireland
Regeneron Study Site
Bologna, Balogna, Italy
Regeneron Study Site
Ancona, Italy
Regeneron Study Site
Chieti, Italy
Regeneron Study Site
Florence, Italy
Regeneron Study Site
Lucca, Italy
Regeneron Study Site
L’Aquila, Italy
Regeneron Study Site
Messina, Italy
Regeneron Study Site
Milan, 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
Regeneron Study Site
Nagakute, Aichi-ken, 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 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-ku, Tokyo, Japan
Regeneron Study Site
Koto-ku, Tokyo, Japan
Regeneron Study Site
Nakano-ku, Tokyo, Japan
Regeneron Study Site 1
Nerima City, Tokyo, Japan
Regeneron Study Site 2
Nerima City, Tokyo, Japan
Regeneron Study Site
Ōta-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
Chūō, Yamanashi, Japan
Regeneron Study Site
Kofu, Yamanashi, 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
Regeneron Study Site
Kaunas, Kaunas County, Lithuania
Regeneron Study Site 1
Vilnius, Vilnius County, Lithuania
Regeneron Study Site 2
Vilnius, Vilnius County, Lithuania
Regeneron Study Site 1
Klaipėda, Lithuania
Regeneron Study Site 2
Klaipėda, Lithuania
Regeneron Study Site
Breda, North Brabant, Netherlands
Regeneron Study Site
Amsterdam, North Holland, Netherlands
Regeneron Study Site
Rotterdam, South Holland, Netherlands
Regeneron Study Site
Groningen, Netherlands
Regeneron Study Site
Utrecht, Netherlands
Regeneron Study Site
Dunedin, South Island, New Zealand
Regeneron Study Site
Auckland, New Zealand
Regeneron Study Site 1
Poznan, Greater Poland Voivodeship, Poland
Regeneron Study Site 2
Poznan, Greater Poland Voivodeship, Poland
Regeneron Study Site 3
Poznan, Greater Poland Voivodeship, Poland
Regeneron Study Site
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Regeneron Study Site 1
Krakow, Lesser Poland Voivodeship, Poland
Regeneron Study Site 2
Krakow, Lesser Poland Voivodeship, Poland
Regeneron Study Site 3
Krakow, Lesser Poland Voivodeship, Poland
Regeneron Study Site 1
Wroclaw, Lower Silesian Voivodeship, Poland
Regeneron Study Site 2
Wroclaw, Lower Silesian Voivodeship, Poland
Regeneron Study Site 3
Wroclaw, Lower Silesian Voivodeship, Poland
Regeneron Study Site
Lublin, Lublin Voivodeship, Poland
Regeneron Study Site 1
Warsaw, Masovian Voivodeship, Poland
Regeneron Study Site 2
Warsaw, Masovian Voivodeship, Poland
Regeneron Study Site 3
Warsaw, Masovian Voivodeship, Poland
Regeneron Study Site 4
Warsaw, Masovian Voivodeship, Poland
Regeneron Study Site 5
Warsaw, Masovian Voivodeship, Poland
Regeneron Study Site 6
Warsaw, Masovian Voivodeship, Poland
Regeneron Study Site 7
Warsaw, Masovian Voivodeship, Poland
Regeneron Study Site
Strzelce Opolskie, Opole Voivodeship, Poland
Regeneron Study Site
Iwonicz-Zdrój, Podkarpackie Voivodeship, Poland
Regeneron Study Site 1
Gdansk, Pomeranian Voivodeship, Poland
Regeneron Study Site 2
Gdansk, Pomeranian Voivodeship, Poland
Regeneron Study Site
Szczecin, West Pomeranian Voivodeship, Poland
Regeneron Study Site
Bialystok, Poland
Regeneron Study Site
Bydgoszcz, Poland
Regeneron Study Site
Chorzów, Poland
Regeneron Study Site
Elblag, 82300, Poland
Regeneron Study Site 1
Katowice, Poland
Regeneron Study Site 2
Katowice, Poland
Regeneron Study Site 3
Katowice, Poland
Regeneron Study Site
Ostrowiec Świętokrzyski, Poland
Regeneron Study Site
Skarżysko-Kamienna, Poland
Regeneron Study Site
Zgierz, 95100, Poland
Regeneron Study Site 1
Lodz, Łódź Voivodeship, Poland
Regeneron Study Site 2
Lodz, Łódź Voivodeship, Poland
Regeneron Study Site 3
Lodz, Łódź Voivodeship, Poland
Regeneron Study Site
Brasov, Romania
Regeneron Study Site
Moscow, Koskva, Russia
Regeneron Study Site
Ryazan, Ryazan Oblast, Russia
Regeneron Study Site
Saint Petersburg, Sankt-Peterburg, Russia
Regeneron Study Site
Kazan', Tatarstan Respublika, Russia
Regeneron Study Site
Chelyabinsk, Russia
Regeneron Study Site 1
Singapore, Central Singapore, Singapore
Regeneron Study Site 2
Singapore, Central Singapore, Singapore
Regeneron Study Site
Singapore, South West, Singapore
Regeneron Study Site
Košice, Slovakia
Regeneron Study Site
Svidník, Slovakia
Regeneron Study Site
Busan, Busan Gwang'yeogsi, South Korea
Regeneron Study Site
Bucheon-si, Kyonggi-do, South Korea
Regeneron Study Site
Hwaseong-si, Kyonggi-do, South Korea
Regeneron Study Site
Suwon, Kyonggi-do, South Korea
Regeneron Study Site
Uijeongbu-si, Kyonggi-do, South Korea
Regeneron Study Site 1
Incheon, South Korea
Regeneron Study Site 2
Incheon, South Korea
Regeneron Study Site 1
Seoul, South Korea
Regeneron Study Site 2
Seoul, South Korea
Regeneron Study Site 3
Seoul, South Korea
Regeneron Study Site 4
Seoul, South Korea
Regeneron Study Site 5
Seoul, South Korea
Regeneron Study Site 6
Seoul, South Korea
Regeneron Study Site 7
Seoul, South Korea
Regeneron Study Site 8
Seoul, South Korea
Regeneron Study Site
Elche, Alicante, Spain
Regeneron Study Site
Badalona, Barcelona, Spain
Regeneron Study Site
Las Palmas de Gran Canaria, Canary Islands, 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
Seville, Spain
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
Related Publications (9)
Simpson EL, Bissonnette R, Deleuran M, Nakahara T, Galus R, de Bruin-Weller M, Coleman A, van Spall M, Chen Z, Avetisova E, Bastian M, Khokhar FA. Dupilumab Treatment Up to 5 Years Shows No Clinically Meaningful Changes in Laboratory Parameters in Adults with Moderate-to-Severe Atopic Dermatitis. Adv Ther. 2026 Jan 21. doi: 10.1007/s12325-025-03458-3. Online ahead of print.
PMID: 41563707DERIVEDKamal MA, Kosloski MP, Lai CH, Partridge MA, Rajadhyaksha M, Kanamaluru V, Bansal A, Shabbir A, Shumel B, Ardeleanu M, Richards SM, Yan H, Xu CR, Rodriguez-Marco A, Xiao J, Khokhar FA, Gherardi G, Babilonia E, Maloney J, Mortensen E, Akinlade B, Braunstein N, Stahl N, Torri A, Davis JD, DiCioccio AT. Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatitis. Front Immunol. 2024 Nov 11;15:1466372. doi: 10.3389/fimmu.2024.1466372. eCollection 2024.
PMID: 39588375DERIVEDBlauvelt A, Wollenberg A, Eichenfield LF, Zhang H, Sierka D, Khokhar FA, Vakil J, Shabbir A, Marco AR, Cyr SL. No Increased Risk of Overall Infection in Adults with Moderate-to-Severe Atopic Dermatitis Treated for up to 4 Years with Dupilumab. Adv Ther. 2023 Jan;40(1):367-380. doi: 10.1007/s12325-022-02322-y. Epub 2022 Nov 1.
PMID: 36318387DERIVEDWechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.
PMID: 35636689DERIVEDBeck LA, Deleuran M, Bissonnette R, de Bruin-Weller M, Galus R, Nakahara T, Seo SJ, Khokhar FA, Vakil J, Xiao J, Marco AR, Levit NA, O'Malley JT, Shabbir A. Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2022 May;23(3):393-408. doi: 10.1007/s40257-022-00685-0. Epub 2022 May 3.
PMID: 35503163DERIVEDArmstrong A, Blauvelt A, Simpson EL, Smith CH, Herranz P, Kataoka Y, Seo SJ, Ferrucci SM, Chao J, Chen Z, Rossi AB, Shumel B, Tomondy P. Continued Treatment with Dupilumab is Associated with Improved Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Not Achieving Optimal Responses with Short-Term Treatment. Dermatol Ther (Heidelb). 2022 Jan;12(1):195-202. doi: 10.1007/s13555-021-00643-4. Epub 2021 Dec 13.
PMID: 34897582DERIVEDYosipovitch G, de Bruin-Weller M, Armstrong A, Wu JJ, Herranz P, Thaci D, Delevry D, Bagousse GB, Zhang R, Shumel B, Rossi AB, Chao J. Dupilumab Treatment Provides Sustained Improvements Over 2 Years in Symptoms and Quality of Life in Adults with Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Dec;11(6):2147-2157. doi: 10.1007/s13555-021-00630-9. Epub 2021 Oct 29.
PMID: 34714527DERIVEDBeck LA, Thaci D, Deleuran M, de Bruin-Weller M, Chen Z, Khokhar FA, Zhang M, Ozturk ZE, Shumel B. Laboratory safety of dupilumab for up to 3 years in adults with moderate-to-severe atopic dermatitis: results from an open-label extension study. J Dermatolog Treat. 2022 May;33(3):1608-1616. doi: 10.1080/09546634.2020.1871463. Epub 2021 Feb 8.
PMID: 33557637DERIVEDBeck LA, Thaci D, Deleuran M, Blauvelt A, Bissonnette R, de Bruin-Weller M, Hide M, Sher L, Hussain I, Chen Z, Khokhar FA, Beazley B, Ruddy M, Patel N, Graham NMH, Ardeleanu M, Shumel B. Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2020 Aug;21(4):567-577. doi: 10.1007/s40257-020-00527-x.
PMID: 32557382DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials Administrator
- Organization
- Regeneron Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2013
First Posted
September 24, 2013
Study Start
October 10, 2013
Primary Completion
June 27, 2022
Study Completion
June 27, 2022
Last Updated
October 17, 2023
Results First Posted
October 17, 2023
Record last verified: 2023-10