Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT02260986
Last Updated: 2017-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
740 participants
INTERVENTIONAL
2014-09-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo qw
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection weekly (qw) from Week 1 to Week 51.
Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Topical Corticosteroid (TCS)
All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.
Dupilumab 300 mg q2w
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo.
Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Topical Corticosteroid (TCS)
All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.
Dupilumab 300 mg qw
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Topical Corticosteroid (TCS)
All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.
Interventions
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Dupilumab
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Placebo (for Dupilumab)
Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
Topical Corticosteroid (TCS)
All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of out-patient treatment with topical AD medication(s).
Exclusion Criteria
2. Important side effects of topical medication (e.g. intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or treating physician;
3. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require such treatment(s) during the first 2 weeks of study treatment:
1. Immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine, mycophenolate-mofetil, Janus kinase inhibitors, interferon-gamma \[IFN-γ\], azathioprine, methotrexate, etc.);
2. Phototherapy for AD;
4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
5. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
6. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at the screening visit;
7. Active or acute infection requiring systemic treatment within 2 weeks before baseline visit;
8. Known or suspected history of immunosuppression;
9. Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the participant's participation in this study.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Phoenix, Arizona, United States
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
Encinitas, California, United States
Oceanside, California, United States
Palmdale, California, United States
San Diego, California, United States
New Haven, Connecticut, United States
Trumbull, Connecticut, United States
Edgewater, Florida, United States
Lake Worth, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Alpharetta, Georgia, United States
Columbus, Georgia, United States
Savannah, Georgia, United States
West Dundee, Illinois, United States
Carmel, Indiana, United States
New Albany, Indiana, United States
Rockville, Maryland, United States
Ann Arbor, Michigan, United States
Bay City, Michigan, United States
Edina, Minnesota, United States
Fridley, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Henderson, Nevada, United States
Verona, New Jersey, United States
Albuquerque, New Mexico, United States
Corning, New York, United States
New York, New York, United States
Smithtown, New York, United States
Stony Brook, New York, United States
Cincinnati, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Lake Oswego, Oregon, United States
Portland, Oregon, United States
Exton, Pennsylvania, United States
Hazleton, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
Dallas, Texas, United States
West Jordan, Utah, United States
South Burlington, Vermont, United States
Henrico, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Spokane, Washington, United States
Phillip, Australian Capital Territory, Australia
Kogarah, New South Wales, Australia
Benowa, Queensland, Australia
Dulwich, Queensland, Australia
Hectorville, South Australia, Australia
Carlton, Victoria, Australia
Surrey, British Columbia, Canada
Vancouver, British Columbia, Canada
Ajax, Ontario, Canada
Barrie, Ontario, Canada
Hamilton, Ontario, Canada
Markham, Ontario, Canada
North Bay, Ontario, Canada
Oakville, Ontario, Canada
Ottawa, Ontario, Canada
Peterborough, Ontario, Canada
Richmond Hill, Ontario, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
Windsor, Ontario, Canada
Drummondville, Quebec, Canada
Québec, , Canada
Hradec Králové, , Czechia
Náchod, , Czechia
Prague, , Czechia
Svitavy, , Czechia
Ústí nad Labem, , Czechia
Orosháza, Bekes County, Hungary
Szolnok, Jász-Nagykun-Szolnok, Hungary
Veszprém, Veszprém megye, Hungary
Budapest, , Hungary
Ancona, , Italy
Bologna, , Italy
Brescia, , Italy
Novara, , Italy
Pavia, , Italy
Perugia, , Italy
Roma, , Italy
Kitakyushu, Fukuoka, Japan
Amagasaki, Hyôgo, Japan
Yokohama, Kanagawa, Japan
Kamimashiki-gun, Kumamoto, Japan
Saitama-shi, Saitama, Japan
Yaizu, Shizuoka, Japan
Koto-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Adachi-ku, Tôkyô, Japan
Chiyoda-ku, Tôkyô, Japan
Nakano, Tôkyô, Japan
Nerima-ku, Tôkyô, Japan
Shibuya-ku, Tôkyô, Japan
Shinagawa-ku, Tôkyô, Japan
Shinjuku-ku, Tôkyô, Japan
Suginami-ku, Tôkyô, Japan
Fukuoka, , Japan
Breda, North Brabant, Netherlands
Amsterdam, North Holland, Netherlands
Rotterdam, South Holland, Netherlands
Groningen, , Netherlands
Utrecht, , Netherlands
Dunedin, South Island, New Zealand
Auckland, , New Zealand
Poznan, Greater Poland Voivodeship, Poland
Krakow, Lesser Poland Voivodeship, Poland
Wroclaw, Lower Silesian Voivodeship, Poland
Lublin, Lublin Voivodeship, Poland
Warsaw, Masovian Voivodeship, Poland
Strzelce Opolskie, Opole Voivodeship, Poland
Iwonicz-Zdrój, Podkarpackie Voivodeship, Poland
Bialystok, Podlaskie Voivodeship, Poland
Gdansk, Pomeranian Voivodeship, Poland
Katowice, Silesian Voivodeship, Poland
Szczecin, West Pomeranian Voivodeship, Poland
Gdynia, , Poland
Lodz, Łódź Voivodeship, Poland
Skarżysko-Kamienna, Świętokrzyskie Voivodeship, Poland
Brasov, Brașov County, Romania
Bucharest, București, Romania
Cluj-Napoca, Cluj, Romania
Craiova, Dolj, Romania
Târgu Mureş, Mureș County, Romania
Bucheon-si, Gyeonggido, South Korea
Suwon, Gyeonggido, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Seodaemun-gu, , South Korea
Uijeongbu-si, , South Korea
Barcelona, Catalonia, Spain
Alicante, , Spain
Madrid, , Spain
Dundee, Angus, United Kingdom
Edgbaston, Birmingham, United Kingdom
Glasgow, Glasgow City, United Kingdom
Sidcup, Kent, United Kingdom
Northwood, Middlesex, United Kingdom
Liverpool, , United Kingdom
Manchester, , United Kingdom
Reading, , United Kingdom
Salford, , United Kingdom
Countries
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References
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Wiseman M, Benvenuto M, Stromkjaer L, Paludan-Muller A, Ryttig L, Petersen AS, Wollenberg A. Cost-Per-Responder Analysis for Tralokinumab and Dupilumab in Combination with Topical Corticosteroids in Patients with Moderate-To-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Oct 16. doi: 10.1007/s13555-025-01565-1. Online ahead of print.
Langley RG, Gherardi G, Coleman A, Ardeleanu M, Rodriguez-Marco A, Levy S, Bansal A, Chen Z, Rossi AB, Shumel B, Khokhar FA. The Safety Data of Dupilumab for the Treatment of Moderate-to-Severe Atopic Dermatitis in Infants, Children, Adolescents, and Adults. Am J Clin Dermatol. 2025 Sep 24. doi: 10.1007/s40257-025-00952-w. Online ahead of print.
Stander S, Yosipovitch G, Kim BS, Steinhoff M, Armstrong A, Legat FJ, Kabashima K, Nakahara T, Igarashi A, Praestgaard AH, Nguyen TV, Bastian M. Optimal Itch Response in Adults Treated with Dupilumab for Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Sep 19. doi: 10.1007/s13555-025-01519-7. Online ahead of print.
Stander S, Yosipovitch G, Simpson EL, Kim BS, Kabashima K, Thaci D, Metz M, Chen Z, Hagen S, Bastian M. Onset and Long-Term Maintenance of Optimal Itch Response in Adult Patients with Moderate-to-Severe Atopic Dermatitis Treated with Dupilumab: Post Hoc Analysis from Two Phase 3 Trials. Adv Ther. 2025 Apr;42(4):1800-1810. doi: 10.1007/s12325-025-03124-8. Epub 2025 Feb 19.
Kamal 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.
Silverberg JI, Lynde CW, Abuabara K, Patruno C, de Benedetto A, Zhang H, Thomas RB, Bego-Le-Bagousse G, Khokhar FA, Vakil J, Marco AR, Levit NA. Efficacy and Safety of Dupilumab Maintained in Adults >/= 60 Years of Age with Moderate-to-Severe Atopic Dermatitis: Analysis of Pooled Data from Four Randomized Clinical Trials. Am J Clin Dermatol. 2023 May;24(3):469-483. doi: 10.1007/s40257-022-00754-4. Epub 2023 Feb 20.
Paller AS, Silverberg JI, Cork MJ, Guttman-Yassky E, Lockshin B, Irvine AD, Kim MB, Kabashima K, Chen Z, Lu Y, Bansal A, Rossi AB, Shabbir A. Efficacy and Safety of Dupilumab in Patients With Erythrodermic Atopic Dermatitis: A Post Hoc Analysis of 6 Randomized Clinical Trials. JAMA Dermatol. 2023 Mar 1;159(3):255-266. doi: 10.1001/jamadermatol.2022.6192.
Wechsler 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.
Blauvelt A, de Bruin-Weller M, Simpson EL, Chen Z, Ardeleanu M, Rossi AB. Consistency of Response to Dupilumab in Adults with Moderate-to-Severe Atopic Dermatitis Over 1 Year. Dermatol Ther (Heidelb). 2022 Jan;12(1):9-13. doi: 10.1007/s13555-021-00657-y. Epub 2022 Jan 7.
Blauvelt A, de Bruin-Weller M, Simpson EL, Chen Z, Zhang A, Shumel B. Dupilumab with Topical Corticosteroids Provides Rapid and Sustained Improvement in Adults with Moderate-to-Severe Atopic Dermatitis Across Anatomic Regions Over 52 Weeks. Dermatol Ther (Heidelb). 2022 Jan;12(1):223-231. doi: 10.1007/s13555-021-00638-1. Epub 2021 Nov 22.
Griffiths C, de Bruin-Weller M, Deleuran M, Fargnoli MC, Staumont-Salle D, Hong CH, Sanchez-Carazo J, Foley P, Seo SJ, Msihid J, Chen Z, Cyr SL, Rossi AB. Dupilumab in Adults with Moderate-to-Severe Atopic Dermatitis and Prior Use of Systemic Non-Steroidal Immunosuppressants: Analysis of Four Phase 3 Trials. Dermatol Ther (Heidelb). 2021 Aug;11(4):1357-1372. doi: 10.1007/s13555-021-00558-0. Epub 2021 Jun 18.
Hamilton JD, Harel S, Swanson BN, Brian W, Chen Z, Rice MS, Amin N, Ardeleanu M, Radin A, Shumel B, Ruddy M, Patel N, Pirozzi G, Mannent L, Graham NMH. Dupilumab suppresses type 2 inflammatory biomarkers across multiple atopic, allergic diseases. Clin Exp Allergy. 2021 Jul;51(7):915-931. doi: 10.1111/cea.13954. Epub 2021 Jun 26.
Wu JJ, Spelman L, Tan JL, Etoh T, Zhang H, Shumel B, Rossi AB. Dupilumab Maintains Long-Term Disease Control in Adults with Moderate-to-Severe Atopic Dermatitis as Measured by Well-Controlled Weeks: Results From the LIBERTY AD CHRONOS Clinical Trial. Dermatol Ther (Heidelb). 2021 Apr;11(2):327-330. doi: 10.1007/s13555-021-00487-y. Epub 2021 Jan 28. No abstract available.
Boguniewicz M, Beck LA, Sher L, Guttman-Yassky E, Thaci D, Blauvelt A, Worm M, Corren J, Soong W, Lio P, Rossi AB, Lu Y, Chao J, Eckert L, Gadkari A, Hultsch T, Ruddy M, Mannent LP, Graham NMH, Pirozzi G, Chen Z, Ardeleanu M. Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1212-1223.e6. doi: 10.1016/j.jaip.2020.12.059. Epub 2021 Jan 13.
Silverberg JI, Simpson EL, Guttman-Yassky E, Cork MJ, de Bruin-Weller M, Yosipovitch G, Eckert L, Chen Z, Ardeleanu M, Shumel B, Hultsch T, Rossi AB, Hamilton JD, Orengo JM, Ruddy M, Graham NMH, Pirozzi G, Gadkari A. Dupilumab Significantly Modulates Pain and Discomfort in Patients With Atopic Dermatitis: A Post Hoc Analysis of 5 Randomized Clinical Trials. Dermatitis. 2021 Oct 1;32(1S):S81-S91. doi: 10.1097/DER.0000000000000698.
Weyne J, Blauvelt A, de Bruin-Weller M, Prens E, Asbell P, Sierka D, Chen Z, Shumel B. Patient-Reported Ocular Disorders and Symptoms in Adults with Moderate-to-Severe Atopic Dermatitis: Screening and Baseline Survey Data from a Clinical Trial. Dermatol Ther (Heidelb). 2020 Dec;10(6):1415-1421. doi: 10.1007/s13555-020-00456-x. Epub 2020 Oct 12.
Katoh N, Kataoka Y, Saeki H, Hide M, Kabashima K, Etoh T, Igarashi A, Imafuku S, Kawashima M, Ohtsuki M, Fujita H, Arima K, Takagi H, Chen Z, Shumel B, Ardeleanu M. Efficacy and safety of dupilumab in Japanese adults with moderate-to-severe atopic dermatitis: a subanalysis of three clinical trials. Br J Dermatol. 2020 Jul;183(1):39-51. doi: 10.1111/bjd.18565. Epub 2019 Nov 28.
Alexis AF, Rendon M, Silverberg JI, Pariser DM, Lockshin B, Griffiths CE, Weisman J, Wollenberg A, Chen Z, Davis JD, Li M, Eckert L, Gadkari A, Shumel B, Rossi AB, Graham NM, Ardeleanu M. Efficacy of Dupilumab in Different Racial Subgroups of Adults With Moderate-to-Severe Atopic Dermatitis in Three Randomized, Placebo-Controlled Phase 3 Trials. J Drugs Dermatol. 2019 Aug 1;18(8):804-813.
Wollenberg A, Beck LA, Blauvelt A, Simpson EL, Chen Z, Chen Q, Shumel B, Khokhar FA, Hultsch T, Rizova E, Rossi AB, Graham NMH, Pirozzi G, Lu Y, Ardeleanu M. Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS). Br J Dermatol. 2020 May;182(5):1120-1135. doi: 10.1111/bjd.18434. Epub 2019 Dec 1.
Eichenfield LF, Bieber T, Beck LA, Simpson EL, Thaci D, de Bruin-Weller M, Deleuran M, Silverberg JI, Ferrandiz C, Folster-Holst R, Chen Z, Graham NMH, Pirozzi G, Akinlade B, Yancopoulos GD, Ardeleanu M. Infections in Dupilumab Clinical Trials in Atopic Dermatitis: A Comprehensive Pooled Analysis. Am J Clin Dermatol. 2019 Jun;20(3):443-456. doi: 10.1007/s40257-019-00445-7.
Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, Simpson EL, Papp KA, Hong HC, Rubel D, Foley P, Prens E, Griffiths CEM, Etoh T, Pinto PH, Pujol RM, Szepietowski JC, Ettler K, Kemeny L, Zhu X, Akinlade B, Hultsch T, Mastey V, Gadkari A, Eckert L, Amin N, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Shumel B. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017 Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1. Epub 2017 May 4.
Other Identifiers
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R668-AD-1224
Identifier Type: -
Identifier Source: org_study_id