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)

NCT03345914 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: R668-AD-16522016-004997-16
• Study Type: interventional
• Target: 367
• Locations: 6 countries
• Sites: 61

Brief Summary

The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to \<12 years of age with severe atopic dermatitis (AD). 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.

Conditions

Dermatitis, Atopic

Keywords

Eczema

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 at Week 16

  The IGA was an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe). The full analysis set (FAS) included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at Week 16 were considered as a non-responder.

  Week 16

Secondary Outcomes (21)

• Percentage of Participants With Eczema Area and Severity Index -75 (EASI-75) (≥ 75 Percent (%) Improvement From Baseline) at Week 16

  Week 16

• Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16

  Baseline (Day 1), Week 16

• Percent Change From Baseline in Weekly Average of Daily Worst Itch Score at Week 16

  Baseline (Day 1), Week 16

• Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Itch Score ≥3 Points at Week 16

  Week 16

• Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Itch Score ≥4 Points at Week 16

  Week 16

Study Arms (3)

Group 1

EXPERIMENTAL

Participants will receive dupilumab, dosing regimen 1

Drug: Dupilumab; Other: Background Treatment: Topical Corticosteroids; Other: Background Treatment: Moisturizers

Group 2

EXPERIMENTAL

Participants will receive dupilumab, dosing regimen 2

Drug: Dupilumab; Other: Background Treatment: Topical Corticosteroids; Other: Background Treatment: Moisturizers

Group 3

EXPERIMENTAL

Participants will receive matching placebo

Drug: Matching Placebo; Other: Background Treatment: Topical Corticosteroids; Other: Background Treatment: Moisturizers

Interventions

Dupilumab DRUG

Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous (SC)

Also known as: DUPIXENT®, REGN668, SAR231893

Group 1; Group 2

Matching Placebo DRUG

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)

Group 3

Background Treatment: Topical Corticosteroids OTHER

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%.

Group 1; Group 2; Group 3

Background Treatment: Moisturizers OTHER

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 1; Group 2; Group 3

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of AD according to the American Academy of Dermatology consensus criteria (Eichenfield 2003) at screening visit
• Chronic AD diagnosed at least 1 year prior to the screening visit
• IGA = 4 at screening and baseline visits
• EASI ≥21 at the screening and baseline visits
• BSA ≥15% at screening and baseline visits
• Documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s)
• 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

You may not qualify if:

• Participation in a prior dupilumab clinical study
• Treatment with a systemic investigational drug before the baseline visit
• Treatment with a topical investigational drug within 2 weeks prior to the baseline visit
• Treatment with crisabarole within 2 weeks prior to the baseline visit
• 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
• Treatment with a topical calcineurin inhibitor (TCI) within 2 weeks prior to the baseline visit
• 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:
• Immunosuppressive/immunomodulating drugs (e.g, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
• Phototherapy for AD
• Treatment with biologics, as follows:
• 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
• Other biologics: within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer
• Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
• Body weight \<15 kg at baseline

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (61)

Regeneron Research Site

Birmingham, Alabama, 35209, United States

Location

Regeneron Research Site

Gilbert, Arizona, 85234, United States

Location

Regeneron Research Site

Bakersfield, California, 93309, United States

Location

Regeneron Research Site

Long Beach, California, 90808, United States

Location

Regeneron Research Site

Mission Viejo, California, 92691, United States

Location

Regeneron Research Site

Rolling Hills Estates, California, 90274, United States

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Regeneron Research Site

San Diego, California, 92123, United States

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Regeneron Research Site

Denver, Colorado, 80206, United States

Location

Regeneron Research Site

Coral Gables, Florida, 33146, United States

Location

Regeneron Research Site

Tampa, Florida, 33612, United States

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Regeneron Research Site

Tampa, Florida, 33624, United States

Location

Regeneron Research Site

Macon, Georgia, 31217, United States

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Regeneron Research Site

Sandy Springs, Georgia, 30328, United States

Location

Regeneron Research Site

Chicago, Illinois, 60611, United States

Location

Regeneron Research Site

Normal, Illinois, 61761, United States

Location

Regeneron Research Site

Rockville, Maryland, 20850, United States

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Regeneron Research Site

Ypsilanti, Michigan, 48197, United States

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Regeneron Research Site

Minneapolis, Minnesota, 55402, United States

Location

Regeneron Research Site

St Louis, Missouri, 63104, United States

Location

Regeneron Research Site

Forest Hills, New York, 11375, United States

Location

Regeneron Research Site

New York, New York, 10029, United States

Location

Regeneron Research Site

Rochester, New York, 14620, United States

Location

Regeneron Research Site

Gahanna, Ohio, 43230, United States

Location

Regeneron Research Site

Portland, Oregon, 97239, United States

Location

Regeneron Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

Regeneron Research Site

Charleston, South Carolina, 29425, United States

Location

Regeneron Research Site

North Charleston, South Carolina, 29420, United States

Location

Regeneron Research Site

Bellaire, Texas, 77401, United States

Location

Regeneron Research Site

San Antonio, Texas, 78218, United States

Location

Regeneron Research Site

Norfolk, Virginia, 23502, United States

Location

Regeneron Research Site

Seattle, Washington, 98105, United States

Location

Regeneron Research Site

Calgary, Alberta, T2G 1B1, Canada

Location

Regeneron Research Site

Markham, Ontario, L3P 1X2, Canada

Location

Regeneron Research Site

Peterborough, Ontario, K9J 5K2, Canada

Location

Regeneron Research Site

Montreal, Quebec, H3T 1C5, Canada

Location

Regeneron Research Site

Kutná Hora, 284 01, Czechia

Location

Regeneron Research Site

Ústí nad Labem, 40113, Czechia

Location

Regeneron Research Site

Munich, Bavaria, 80337, Germany

Location

Regeneron Research Site

Osnabrück, Lower Saxony, 49074, Germany

Location

Regeneron Research Site

Münster, North Rhine-Westphalia, 48149, Germany

Location

Regeneron Research Site

Dresden, Saxony, 01307, Germany

Location

Regeneron Research Site

Gera, Thuringia, 07548, Germany

Location

Regeneron Research Site

Bad Bentheim, 48455, Germany

Location

Regeneron Research Site

Hamburg, 22149, Germany

Location

Regeneron Research Site

Wroclaw, Lower Silesian Voivodeship, 50381, Poland

Location

Regeneron Research Site

Krakow, Malopolska, 30363, Poland

Location

Regeneron Research Site

Bialystok, 15-453, Poland

Location

Regeneron Research Site

Bydgoszcz, 85-065, Poland

Location

Regeneron Research Site

Gdansk, 80-152, Poland

Location

Regeneron Research Site

Katowice, 40-611, Poland

Location

Regeneron Research Site

Katowice, 40-648, Poland

Location

Regeneron Research Site

Katowice, 40123, Poland

Location

Regeneron Research Site

Lodz, 90-265, Poland

Location

Regeneron Research Site

Świętokrzyskie, 27-400, Poland

Location

Regeneron Research Site

Warsaw, 01-142, Poland

Location

Regeneron Research Site

Warsaw, 01-817, Poland

Location

Regeneron Research Site

Warsaw, 02-758, Poland

Location

Regeneron Research Site

London, SE1 7EH, United Kingdom

Location

Regeneron Research Site

Manchester, M13 9WL, United Kingdom

Location

Regeneron Research Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Regeneron Research Site

Sheffield, S10 2TH, United Kingdom

Location

Related Publications (9)

• 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 Nov;26(6):981-1002. doi: 10.1007/s40257-025-00952-w. Epub 2025 Sep 24.

  PMID: 40993471 DERIVED

• 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.

  PMID: 39588375 DERIVED

• 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.

  PMID: 37750994 DERIVED

• 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.

  PMID: 37300760 DERIVED

• 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.

  PMID: 36269504 DERIVED

• 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.

  PMID: 34462864 DERIVED

• 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.

  PMID: 34427891 DERIVED

• 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.

  PMID: 34270797 DERIVED

• 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.

  PMID: 34046851 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Trial Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 17, 2017
• Study Start: November 17, 2017
• Primary Completion: June 20, 2019
• Study Completion: September 10, 2019
• Last Updated: August 13, 2020
• Results First Posted: August 13, 2020

Record last verified: 2020-07

Locations

CA (4); CZ (2); DE (7); US (31); GB (4); PL (13)