Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT01859988
Last Updated: 2017-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
380 participants
INTERVENTIONAL
2013-05-31
2014-09-30
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
QUADRUPLE
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 every week (qw) from Week 1 to Week 15.
Placebo
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 qw from Week 1 to Week 15.
Dupilumab
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 a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 15.
Dupilumab
Placebo
Dupilumab 200 mg q2w
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
Dupilumab
Placebo
Dupilumab 300 mg q4w
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 every 4 weeks (q4w) and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.
Dupilumab
Placebo
Dupilumab 100 mg q4w
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.
Dupilumab
Placebo
Interventions
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Dupilumab
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. History of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable (e.g, because of important side effects or safety risks)
3. Willing and able to comply with all clinic visits and study-related procedures
Exclusion Criteria
2. Presence of certain laboratory abnormalities at the screening visit
3. Treatment with an investigational drug within 8 weeks of baseline visit
4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
5. Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
6. Known history of human immunodeficiency virus (HIV) infection
7. History of malignancy within 5 years before the baseline visit (with certain exceptions)
8. Planned surgical procedure during the length of the study
9. High risk of parasite infection
10. Any other medical or psychological condition that in the opinion of the investigator or the sponsor's medical monitor, would place the participants at risk, interfere with participation in the study or interfere with interpretation of study results
11. Pregnant or breast-feeding women
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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Birmingham, Alabama, United States
Mobile, Alabama, United States
Tucson, Arizona, United States
Bakersfield, California, United States
San Diego, California, United States
Santa Monica, California, United States
Jacksonville, Florida, United States
Ormond Beach, Florida, United States
Skokie, Illinois, United States
New Orleans, Louisiana, United States
Andover, Massachusetts, United States
Boston, Massachusetts, United States
Troy, Michigan, United States
St Louis, Missouri, United States
New York, New York, United States
Rochester, New York, United States
Winston-Salem, North Carolina, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Johnston, Rhode Island, United States
Greer, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Vancouver (2 Locations), British Columbia, Canada
Winnipeg, Manitoba, Canada
Barrie, Ontario, Canada
Hamilton, Ontario, Canada
Markham, Ontario, Canada
Oakville, Ontario, Canada
Peterborough, Ontario, Canada
Richmond Hill, Ontario, Canada
Waterloo, Ontario, Canada
Windsor, Ontario, Canada
Saint-Hyacinthe, Quebec, Canada
Québec, , Canada
Kutná Hora, , Czechia
Náchod, , Czechia
Prague, , Czechia
Svitavy, , Czechia
Ústí nad Labem, , Czechia
Augsburg, , Germany
Baden, , Germany
Berlin, , Germany
Bonn, , Germany
Dresden, , Germany
Dülmen, , Germany
Frankfurt am Main, , Germany
Frankfurt/Main, Hessen, , Germany
Gera, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Kiel, , Germany
Mahlow, , Germany
Munich, , Germany
Münster, , Germany
Osnabrück, , Germany
Tübingen, , Germany
Borsod-Abauj-Zemplen, , Hungary
Budapest, , Hungary
Kaposvár, , Hungary
Szeged, , Hungary
Szolnok, , Hungary
Tolna, , Hungary
Fukuoka, , Japan
Hokkaido, , Japan
Saitama, , Japan
Tokyo, Bunkyo-ku, , Japan
Tokyo, Chiyoda-ku, , Japan
Tokyo, Nakano-ku, , Japan
Tokyo, Nerima-ku, , Japan
Tokyo, Shibuya-ku, , Japan
Tokyo, Shinagawa-ku, , Japan
Tokyo, Shinjuku-ku (2 Locations), , Japan
Tokyo, Suginami-ku (2 Locations), , Japan
Yokohama, , Japan
Gdansk (2 Locations), , Poland
Katowice, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw (2 Locations), , Poland
Wroclaw, , Poland
Countries
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References
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Thaci D, Simpson EL, Beck LA, Bieber T, Blauvelt A, Papp K, Soong W, Worm M, Szepietowski JC, Sofen H, Kawashima M, Wu R, Weinstein SP, Graham NM, Pirozzi G, Teper A, Sutherland ER, Mastey V, Stahl N, Yancopoulos GD, Ardeleanu M. Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2016 Jan 2;387(10013):40-52. doi: 10.1016/S0140-6736(15)00388-8. Epub 2015 Oct 8.
Simpson EL, Bieber T, Eckert L, Wu R, Ardeleanu M, Graham NM, Pirozzi G, Mastey V. Patient burden of moderate to severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults. J Am Acad Dermatol. 2016 Mar;74(3):491-8. doi: 10.1016/j.jaad.2015.10.043. Epub 2016 Jan 14.
Simpson EL, Gadkari A, Worm M, Soong W, Blauvelt A, Eckert L, Wu R, Ardeleanu M, Graham NMH, Pirozzi G, Sutherland ER, Mastey V. Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD). J Am Acad Dermatol. 2016 Sep;75(3):506-515. doi: 10.1016/j.jaad.2016.04.054. Epub 2016 Jun 4.
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.
Kamal MA, Davis JD, Kovalenko P, Srinivasan K, Simpson EL, Nakahara T, Sugaya M, Igarashi A, Ardeleanu M, Xu C, Arima K. Pharmacokinetics, pharmacodynamics, and exposure-efficacy of dupilumab in adults with atopic dermatitis. Clin Transl Sci. 2022 Oct;15(10):2342-2354. doi: 10.1111/cts.13363. Epub 2022 Aug 20.
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.
Other Identifiers
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R668-AD-1021
Identifier Type: -
Identifier Source: org_study_id
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