drugset / Trial / NCT03346434
Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years of age with moderate-to-severe atopic dermatitis (AD).
Timeline
- Start
- 2017-11-30
- Primary completion
- 2021-07-08
- Completion
- 2021-07-08
Outcome
Met primary endpoint
registry p < 0.0001; Percentage difference 23.8 (95% CI 13.27 to 34.37) NCT03346434 ↗
registry p < 0.0001; Percentage difference 42.3 (95% CI 29.47 to 55.16) NCT03346434 ↗
release “Dupixent® (dupilumab) to treat moderate-to-severe atopic dermatitis in children aged 6 months to 5 years. The trial met its primary and all secondary endpoints” regeneron.com ↗
release “children aged 6 months to 5 years with moderate-to-severe atopic dermatitis , met its primary and all secondary endpoints” sanofi.com ↗
release “trial in children 6 months to 5 years of age recently published in The Lancet, which met all primary and secondary endpoints” regeneron.com ↗
Publications
- Boguniewicz M, Sher LD, Paller AS, Arkwright PD, Yoshihara S, Smith Begolka W, Chen Z, Shah P, Rodriguez Marco A. Dupilumab is Effective in Young Children with Atopic Dermatitis Regardless of Type 2 Comorbidities. J Asthma Allergy. 2026 May 19;19:590176. doi: 10.2147/JAA.S590176. eCollection 2026.
- Paller AS, Pinter A, Wine Lee L, Aschoff R, Zdybski J, Schnopp C, Khokhar FA, Praestgaard AH, Bansal A, Shumel B, Bastian M. Long-Term Safety and Efficacy of Dupilumab Treatment in Children Aged 6 Months to 5 Years with Severe Atopic Dermatitis. Paediatr Drugs. 2026 May;28(3):307-320. doi: 10.1007/s40272-026-00747-4. Epub 2026 Apr 2.
- 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.
- Rossi AB, Mello AM, Zahn J. Dupilumab Efficacy in Children with Atopic Dermatitis with Different Phenotypes and Endotypes: A Case Series. Adv Ther. 2025 Jul;42(7):3186-3206. doi: 10.1007/s12325-025-03150-6. Epub 2025 May 8.
- 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.
- Boguniewicz M, Sher LD, Paller AS, Arkwright PD, Yoshihara S, Chen Z, Shah P, Marco AR. Dupilumab is Efficacious in Young Children with Atopic Dermatitis Regardless of Type 2 Comorbidities. Adv Ther. 2024 Dec;41(12):4601-4616. doi: 10.1007/s12325-024-02998-4. Epub 2024 Oct 29.
- Paller AS, Siegfried EC, Simpson EL, Cork MJ, Sidbury R, Chen IH, Khokhar FA, Xiao J, Dubost-Brama A, Bansal A. Dupilumab Safety and Efficacy up to 1 Year in Children Aged 6 Months to 5 Years with Atopic Dermatitis: Results from a Phase 3 Open-Label Extension Study. Am J Clin Dermatol. 2024 Jul;25(4):655-668. doi: 10.1007/s40257-024-00859-y. Epub 2024 May 14.
- Paller AS, Siegfried EC, Cork MJ, Arkwright PD, Eichenfield LF, Ramien M, Khokhar FA, Chen Z, Zhang A, Cyr SL. Infections in Children Aged 6 Months to 5 Years Treated with Dupilumab in a Placebo-Controlled Clinical Trial of Moderate-to-Severe Atopic Dermatitis. Paediatr Drugs. 2024 Mar;26(2):163-173. doi: 10.1007/s40272-023-00611-9. Epub 2024 Jan 24.
- Paller AS, Pinter A, Wine Lee L, Aschoff R, Zdybski J, Schnopp C, Praestgaard A, Bansal A, Shumel B, Prescilla R, Bastian M. Efficacy and Safety of Dupilumab Treatment with Concomitant Topical Corticosteroids in Children Aged 6 Months to 5 Years with Severe Atopic Dermatitis. Adv Ther. 2024 Mar;41(3):1046-1061. doi: 10.1007/s12325-023-02753-1. Epub 2024 Jan 9.
- Siegfried EC, Simpson EL, Cork MJ, Arkwright PD, Wine Lee L, Chen Z, Prescilla R, Bansal A, Levit NA, Rodriguez Marco A. Dupilumab Treatment Leads to Rapid and Consistent Improvement of Atopic Dermatitis in All Anatomical Regions in Patients Aged 6 Months to 5 Years. Dermatol Ther (Heidelb). 2023 Sep;13(9):1987-2000. doi: 10.1007/s13555-023-00960-w. Epub 2023 Jul 22.
- Yang N, Ye Y, Shao J, Wu H, Xu Q, Zhu J, Liu J, Li Z. Efficacy of Dupilumab in Children 6 Months to 11 Years Old With Atopic Dermatitis: A Retrospective Real-World Study in China. Dermatitis. 2024 Jan-Feb;35(S1):S39-S46. doi: 10.1089/derm.2022.0069. Epub 2023 Feb 17.
- Paller AS, Siegfried EC, Cork MJ, Wollenberg A, Arkwright PD, Gonzalez ME, Lockshin B, Chen Z, Bansal A, Levit NA, Prescilla R. Laboratory Safety from a Randomized 16-Week Phase III Study of Dupilumab in Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis. Paediatr Drugs. 2023 Jan;25(1):67-77. doi: 10.1007/s40272-022-00553-8. Epub 2022 Dec 19.
- Paller AS, Simpson EL, Siegfried EC, Cork MJ, Wollenberg A, Arkwright PD, Soong W, Gonzalez ME, Schneider LC, Sidbury R, Lockshin B, Meltzer S, Wang Z, Mannent LP, Amin N, Sun Y, Laws E, Akinlade B, Dillon M, Kosloski MP, Kamal MA, Dubost-Brama A, Patel N, Weinreich DM, Yancopoulos GD, O'Malley JT, Bansal A; participating investigators. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022 Sep 17;400(10356):908-919. doi: 10.1016/S0140-6736(22)01539-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | 200 mg | Subcutaneous |
| Subject | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |