Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)
NCT ID: NCT03345914
Last Updated: 2020-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
367 participants
INTERVENTIONAL
2017-11-17
2019-09-10
Brief Summary
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The secondary objective is to assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to \<12 years of age with severe AD.
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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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Group 1
Participants will receive dupilumab, dosing regimen 1
Dupilumab
Pharmaceutical form: Solution for injection in pre-filled syringe;
Route of administration: Subcutaneous (SC)
Background Treatment: Topical Corticosteroids
All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.
Background Treatment: Moisturizers
All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.
Group 2
Participants will receive dupilumab, dosing regimen 2
Dupilumab
Pharmaceutical form: Solution for injection in pre-filled syringe;
Route of administration: Subcutaneous (SC)
Background Treatment: Topical Corticosteroids
All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.
Background Treatment: Moisturizers
All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.
Group 3
Participants will receive matching placebo
Matching Placebo
Pharmaceutical form: Solution for injection;
Route of administration: Subcutaneous (SC)
Background Treatment: Topical Corticosteroids
All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.
Background Treatment: Moisturizers
All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.
Interventions
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Dupilumab
Pharmaceutical form: Solution for injection in pre-filled syringe;
Route of administration: Subcutaneous (SC)
Matching Placebo
Pharmaceutical form: Solution for injection;
Route of administration: Subcutaneous (SC)
Background Treatment: Topical Corticosteroids
All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.
Background Treatment: Moisturizers
All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chronic AD diagnosed at least 1 year prior to the screening visit
3. IGA = 4 at screening and baseline visits
4. EASI ≥21 at the screening and baseline visits
5. BSA ≥15% at screening and baseline visits
6. Documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s)
7. At least 11 (of a total of 14) applications of a stable dose of topical emollient (moisturizer) twice daily during the 7 consecutive days immediately before the baseline visit
Exclusion Criteria
2. Treatment with a systemic investigational drug before the baseline visit
3. Treatment with a topical investigational drug within 2 weeks prior to the baseline visit
4. Treatment with crisabarole within 2 weeks prior to the baseline visit
5. History of important side effects of medium potency topical corticosteroids (e.g, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or patient's treating physician
6. Treatment with a topical calcineurin inhibitor (TCI) within 2 weeks prior to the baseline visit
7. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
1. Immunosuppressive/immunomodulating drugs (e.g, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
2. Phototherapy for AD
8. Treatment with biologics, as follows:
1. Any cell-depleting agents including but not limited to rituximab:
within 6 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer
2. Other biologics: within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer
9. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
10. Body weight \<15 kg at baseline
6 Years
11 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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Regeneron Research Site
Birmingham, Alabama, United States
Regeneron Research Site
Gilbert, Arizona, United States
Regeneron Research Site
Bakersfield, California, United States
Regeneron Research Site
Long Beach, California, United States
Regeneron Research Site
Mission Viejo, California, United States
Regeneron Research Site
Rolling Hills Estates, California, United States
Regeneron Research Site
San Diego, California, United States
Regeneron Research Site
Denver, Colorado, United States
Regeneron Research Site
Coral Gables, Florida, United States
Regeneron Research Site
Tampa, Florida, United States
Regeneron Research Site
Tampa, Florida, United States
Regeneron Research Site
Macon, Georgia, United States
Regeneron Research Site
Sandy Springs, Georgia, United States
Regeneron Research Site
Chicago, Illinois, United States
Regeneron Research Site
Normal, Illinois, United States
Regeneron Research Site
Rockville, Maryland, United States
Regeneron Research Site
Ypsilanti, Michigan, United States
Regeneron Research Site
Minneapolis, Minnesota, United States
Regeneron Research Site
St Louis, Missouri, United States
Regeneron Research Site
Forest Hills, New York, United States
Regeneron Research Site
New York, New York, United States
Regeneron Research Site
Rochester, New York, United States
Regeneron Research Site
Gahanna, Ohio, United States
Regeneron Research Site
Portland, Oregon, United States
Regeneron Research Site
Philadelphia, Pennsylvania, United States
Regeneron Research Site
Charleston, South Carolina, United States
Regeneron Research Site
North Charleston, South Carolina, United States
Regeneron Research Site
Bellaire, Texas, United States
Regeneron Research Site
San Antonio, Texas, United States
Regeneron Research Site
Norfolk, Virginia, United States
Regeneron Research Site
Seattle, Washington, United States
Regeneron Research Site
Calgary, Alberta, Canada
Regeneron Research Site
Markham, Ontario, Canada
Regeneron Research Site
Peterborough, Ontario, Canada
Regeneron Research Site
Montreal, Quebec, Canada
Regeneron Research Site
Kutná Hora, , Czechia
Regeneron Research Site
Ústí nad Labem, , Czechia
Regeneron Research Site
Munich, Bavaria, Germany
Regeneron Research Site
Osnabrück, Lower Saxony, Germany
Regeneron Research Site
Münster, North Rhine-Westphalia, Germany
Regeneron Research Site
Dresden, Saxony, Germany
Regeneron Research Site
Gera, Thuringia, Germany
Regeneron Research Site
Bad Bentheim, , Germany
Regeneron Research Site
Hamburg, , Germany
Regeneron Research Site
Wroclaw, Lower Silesian Voivodeship, Poland
Regeneron Research Site
Krakow, Malopolska, Poland
Regeneron Research Site
Bialystok, , Poland
Regeneron Research Site
Bydgoszcz, , Poland
Regeneron Research Site
Gdansk, , Poland
Regeneron Research Site
Katowice, , Poland
Regeneron Research Site
Katowice, , Poland
Regeneron Research Site
Katowice, , Poland
Regeneron Research Site
Lodz, , Poland
Regeneron Research Site
Świętokrzyskie, , Poland
Regeneron Research Site
Warsaw, , Poland
Regeneron Research Site
Warsaw, , Poland
Regeneron Research Site
Warsaw, , Poland
Regeneron Research Site
London, , United Kingdom
Regeneron Research Site
Manchester, , United Kingdom
Regeneron Research Site
Newcastle upon Tyne, , United Kingdom
Regeneron Research Site
Sheffield, , United Kingdom
Countries
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References
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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.
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.
Cork MJ, Thaci D, Eichenfield LF, Arkwright PD, Chen Z, Thomas RB, Kosloski MP, Dubost-Brama A, Prescilla R, Bansal A, Levit NA. Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6-11 Years of Age with Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2023 Nov;13(11):2697-2719. doi: 10.1007/s13555-023-01016-9. Epub 2023 Sep 26.
Siegfried EC, Cork MJ, Katoh N, Zhang H, Chuang CC, Thomas RB, Rossi AB, Cyr SL, Zhang A. Dupilumab Provides Clinically Meaningful Responses in Children Aged 6-11 Years with Severe Atopic Dermatitis: Post Hoc Analysis Results from a Phase III Trial. Am J Clin Dermatol. 2023 Sep;24(5):787-798. doi: 10.1007/s40257-023-00791-7. Epub 2023 Jun 10.
Paller AS, Yosipovitch G, Weidinger S, DiBenedetti D, Whalley D, Gadkari A, Guillemin I, Zhang H, Eckert L, Chao J, Bansal A, Chuang CC, Delevry D. Development, Psychometric Validation and Responder Definition of Worst Itch Scale in Children with Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2022 Dec;12(12):2839-2850. doi: 10.1007/s13555-022-00804-z. Epub 2022 Oct 21.
Paller AS, Wollenberg A, Siegfried E, Thaci D, Cork MJ, Arkwright PD, Gooderham M, Sun X, O'Malley JT, Khokhar FA, Vakil J, Bansal A, Rosner K, Shumel B, Levit NA. Laboratory Safety of Dupilumab in Patients Aged 6-11 Years with Severe Atopic Dermatitis: Results from a Phase III Clinical Trial. Paediatr Drugs. 2021 Sep;23(5):515-527. doi: 10.1007/s40272-021-00459-x. Epub 2021 Aug 31.
Simpson EL, Paller AS, Siegfried EC, Thaci D, Wollenberg A, Cork MJ, Marcoux D, Huang R, Chen Z, Rossi AB, Shumel B, Sierka D, Bansal A. Dupilumab Demonstrates Rapid and Consistent Improvement in Extent and Signs of Atopic Dermatitis Across All Anatomical Regions in Pediatric Patients 6 Years of Age and Older. Dermatol Ther (Heidelb). 2021 Oct;11(5):1643-1656. doi: 10.1007/s13555-021-00568-y. Epub 2021 Aug 24.
Kamal MA, Kovalenko P, Kosloski MP, Srinivasan K, Zhang Y, Rajadhyaksha M, Lai CH, Kanamaluru V, Xu C, Sun X, Simpson EL, Paller AS, Siegfried EC, Shumel B, Bansal A, Al-Huniti N, Davis JD. The Posology of Dupilumab in Pediatric Patients With Atopic Dermatitis. Clin Pharmacol Ther. 2021 Nov;110(5):1318-1328. doi: 10.1002/cpt.2366. Epub 2021 Aug 24.
Simpson EL, de Bruin-Weller M, Bansal A, Chen Z, Nelson L, Whalley D, Prescilla R, Guillemin I, Delevry D. Definition of Clinically Meaningful Within-Patient Changes in POEM and CDLQI in Children 6 to 11 Years of Age with Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Aug;11(4):1415-1422. doi: 10.1007/s13555-021-00543-7. Epub 2021 May 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-004997-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R668-AD-1652
Identifier Type: -
Identifier Source: org_study_id
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