Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
Summary
The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe atopic dermatitis (AD). The secondary objective of the study was to assess the safety of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe AD.
Timeline
- Start
- 2017-03-21
- Primary completion
- 2018-04-04
- Completion
- 2018-06-05
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Dupilumab 200 mg or 300 mg Q2W; p < 0.0001; percentage difference 22 (95% CI 12.2 to 31.87) NCT03054428 ↗
registry analysis (superiority test); Placebo vs Dupilumab 300 mg Q4W; p = 0.0007; percentage difference 15.5 (95% CI 6.7 to 24.31) NCT03054428 ↗
registry analysis (superiority test); Placebo vs Dupilumab 200 mg or 300 mg Q2W; p < 0.0001; percentage difference 33.2 (95% CI 21.07 to 45.39) NCT03054428 ↗
registry analysis (superiority test); Placebo vs Dupilumab 300 mg Q4W; p < 0.0001; percentage difference 29.9 (95% CI 17.94 to 41.78) NCT03054428 ↗
release “a pivotal Phase 3 trial evaluating DUPIXENT® (dupilumab) to treat moderate-to-severe atopic dermatitis in adolescents (ages 12-17) met its primary and key secondary endpoints.” regeneron.com ↗
release “achieved the primary endpoint – clear or almost-clear skin (IGA; score of 0 or 1) – compared with 2% with placebo” regeneron.com ↗
release “In a Phase 3 trial, Dupixent significantly reduced the extent and severity of disease and itching, and helped adolescents achieve clearer skin” regeneron.com ↗
release “24% of patients who received Dupixent achieved clear or almost clear skin compared to 2% with placebo” regeneron.com ↗
Publications
- 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.
- 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.
- 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.
- Blauvelt A, Guttman-Yassky E, Paller AS, Simpson EL, Cork MJ, Weisman J, Browning J, Soong W, Sun X, Chen Z, Kosloski MP, Kamal MA, Delevry D, Chuang CC, O'Malley JT, Bansal A. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022 May;23(3):365-383. doi: 10.1007/s40257-022-00683-2. Epub 2022 May 14.
- 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.
- Siegfried EC, Bieber T, Simpson EL, Paller AS, Beck LA, Boguniewicz M, Schneider LC, Khokhar FA, Chen Z, Prescilla R, Mina-Osorio P, Bansal A. Effect of Dupilumab on Laboratory Parameters in Adolescents with Atopic Dermatitis: Results from a Randomized, Placebo-Controlled, Phase 3 Clinical Trial. Am J Clin Dermatol. 2021 Mar;22(2):243-255. doi: 10.1007/s40257-020-00583-3. Epub 2021 Mar 3.
- Bansal A, Simpson EL, Paller AS, Siegfried EC, Blauvelt A, de Bruin-Weller M, Corren J, Sher L, Guttman-Yassky E, Chen Z, Daizadeh N, Kamal MA, Shumel B, Mina-Osorio P, Mannent L, Patel N, Graham NMH, Khokhar FA, Ardeleanu M. Conjunctivitis in Dupilumab Clinical Trials for Adolescents with Atopic Dermatitis or Asthma. Am J Clin Dermatol. 2021 Jan;22(1):101-115. doi: 10.1007/s40257-020-00577-1.
- Silverberg JI, Yosipovitch G, Simpson EL, Kim BS, Wu JJ, Eckert L, Guillemin I, Chen Z, Ardeleanu M, Bansal A, Kaur M, Rossi AB, Graham NMH, Patel N, Gadkari A. Dupilumab treatment results in early and sustained improvements in itch in adolescents and adults with moderate to severe atopic dermatitis: Analysis of the randomized phase 3 studies SOLO 1 and SOLO 2, AD ADOL, and CHRONOS. J Am Acad Dermatol. 2020 Jun;82(6):1328-1336. doi: 10.1016/j.jaad.2020.02.060. Epub 2020 Mar 3.
- Paller AS, Bansal A, Simpson EL, Boguniewicz M, Blauvelt A, Siegfried EC, Guttman-Yassky E, Hultsch T, Chen Z, Mina-Osorio P, Lu Y, Rossi AB, He X, Kamal M, Graham NMH, Pirozzi G, Ruddy M, Eckert L, Gadkari A. Clinically Meaningful Responses to Dupilumab in Adolescents with Uncontrolled Moderate-to-Severe Atopic Dermatitis: Post-hoc Analyses from a Randomized Clinical Trial. Am J Clin Dermatol. 2020 Feb;21(1):119-131. doi: 10.1007/s40257-019-00478-y.
- Simpson EL, Paller AS, Siegfried EC, Boguniewicz M, Sher L, Gooderham MJ, Beck LA, Guttman-Yassky E, Pariser D, Blauvelt A, Weisman J, Lockshin B, Hultsch T, Zhang Q, Kamal MA, Davis JD, Akinlade B, Staudinger H, Hamilton JD, Graham NMH, Pirozzi G, Gadkari A, Eckert L, Stahl N, Yancopoulos GD, Ruddy M, Bansal A. Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2020 Jan 1;156(1):44-56. doi: 10.1001/jamadermatol.2019.3336.
- Simpson EL, de Bruin-Weller M, Eckert L, Whalley D, Guillemin I, Reaney M, Chen Z, Nelson L, Qin S, Bansal A, Gadkari A. Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children's Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis. Dermatol Ther (Heidelb). 2019 Dec;9(4):799-805. doi: 10.1007/s13555-019-00333-2. Epub 2019 Oct 22.
- Cork MJ, Thaci D, Eichenfield LF, Arkwright PD, Hultsch T, Davis JD, Zhang Y, Zhu X, Chen Z, Li M, Ardeleanu M, Teper A, Akinlade B, Gadkari A, Eckert L, Kamal MA, Ruddy M, Graham NMH, Pirozzi G, Stahl N, DiCioccio AT, Bansal A. Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: results from a phase IIa open-label trial and subsequent phase III open-label extension. Br J Dermatol. 2020 Jan;182(1):85-96. doi: 10.1111/bjd.18476. Epub 2019 Oct 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | 200 mg | Subcutaneous |
| Subject | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |