Evaluation of Dupilumab in Children With Uncontrolled Asthma
Summary
Primary Objective: To evaluate the efficacy of dupilumab in children 6 to less than (\<) 12 years of age with uncontrolled persistent asthma. Secondary Objective: To evaluate in children 6 to \<12 years of age with uncontrolled persistent asthma: * The safety and tolerability of dupilumab. * The evaluate the effect of dupilumab in improving participant reported outcomes including health related quality of life. * The dupilumab systemic exposure and incidence of anti-drug antibodies. * The evaluate the association between dupilumab treatment and pediatric immune responses to vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal trivalent/quadrivalent influenza vaccine.
Timeline
- Start
- 2017-04-21
- Primary completion
- 2020-08-26
- Completion
- 2020-08-26
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Dupilumab; p <0.0001; Risk Ratio (RR) 0.353 (95% CI 0.222 to 0.562) NCT02948959 ↗
registry analysis (superiority test); Placebo vs Dupilumab; p <0.0001; Risk Ratio (RR) 0.407 (95% CI 0.274 to 0.605) NCT02948959 ↗
release “Dupixent ® (dupilumab) met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.” sanofi.com ↗
Publications
- Jackson DJ, Hamelmann E, Roberts G, Bacharier LB, Xia C, Gall R, Ledanois O, Coleman A, Tawo K, Jacob-Nara JA, Radwan A, Rowe PJ, Deniz Y. Dupilumab Efficacy and Safety in Children With Moderate to Severe Asthma and High Blood Eosinophils: A Post Hoc Analysis of VOYAGE. J Allergy Clin Immunol Pract. 2025 Mar;13(3):568-575. doi: 10.1016/j.jaip.2024.11.014. Epub 2024 Nov 28.
- Guilbert TW, Murphy KR, Hamelmann E, Ross KR, Gupta A, Fiocchi A, Xia C, Gall R, Ledanois O, Radwan A, Jacob-Nara JA, Rowe PJ, Deniz Y. Impact of Lung Function on Asthma Exacerbation Rates in Children Treated with Dupilumab: The VOYAGE Study. J Asthma Allergy. 2024 Feb 8;17:81-87. doi: 10.2147/JAA.S425101. eCollection 2024.
- Bacharier LB, Pavord ID, Maspero JF, Jackson DJ, Fiocchi AG, Mao X, Jacob-Nara JA, Deniz Y, Laws E, Mannent LP, Amin N, Akinlade B, Staudinger HW, Lederer DJ, Hardin M. Blood eosinophils and fractional exhaled nitric oxide are prognostic and predictive biomarkers in childhood asthma. J Allergy Clin Immunol. 2024 Jul;154(1):101-110. doi: 10.1016/j.jaci.2023.09.044. Epub 2024 Jan 23.
- Bacharier LB, Guilbert TW, Katelaris CH, Deschildre A, Phipatanakul W, Liu D, Altincatal A, Mannent LP, Amin N, Laws E, Akinlade B, Jacob-Nara JA, Deniz Y, Rowe PJ, Lederer DJ, Hardin M. Dupilumab Improves Lung Function Parameters in Pediatric Type 2 Asthma: VOYAGE Study. J Allergy Clin Immunol Pract. 2024 Apr;12(4):948-959. doi: 10.1016/j.jaip.2023.12.006. Epub 2023 Dec 11.
- Fiocchi AG, Phipatanakul W, Zeiger RS, Durrani SR, Cole J, Msihid J, Gall R, Jacob-Nara JA, Deniz Y, Rowe PJ, Lederer DJ, Hardin M, Zhang Y, Khan AH. Dupilumab leads to better-controlled asthma and quality of life in children: the VOYAGE study. Eur Respir J. 2023 Nov 2;62(5):2300558. doi: 10.1183/13993003.00558-2023. Print 2023 Nov.
- Papadopoulos NG, Szefler SJ, Bacharier LB, Maspero JF, Domingo C, Fiocchi A, Lee JK, Daizadeh N, Lederer DJ, Hardin M, Gall R, Djandji M, Siddiqui S, Jacob-Nara JA, Deniz Y, Rowe PJ. Assessment of dupilumab in children with moderate-to-severe type 2 asthma with or without evidence of allergic asthma. Allergy. 2023 Aug;78(8):2157-2167. doi: 10.1111/all.15743. Epub 2023 May 25.
- Jackson DJ, Bacharier LB, Phipatanakul W, Sher L, Domingo C, Papadopoulos N, Modena B, Li N, Xia C, Kamal MA, Dillon M, Wolfe K, Gall R, Amin N, Mannent LP, Laws E, Rowe PJ, Jacob-Nara JA, Deniz Y, Lederer DJ, Hardin M, Xu C. Dupilumab pharmacokinetics and effect on type 2 biomarkers in children with moderate-to-severe asthma. Ann Allergy Asthma Immunol. 2023 Jul;131(1):44-51.e4. doi: 10.1016/j.anai.2023.03.014. Epub 2023 Mar 22.
- Bacharier LB, Maspero JF, Katelaris CH, Fiocchi AG, Gagnon R, de Mir I, Jain N, Sher LD, Mao X, Liu D, Zhang Y, Khan AH, Kapoor U, Khokhar FA, Rowe PJ, Deniz Y, Ruddy M, Laws E, Patel N, Weinreich DM, Yancopoulos GD, Amin N, Mannent LP, Lederer DJ, Hardin M; Liberty Asthma VOYAGE Investigators. Dupilumab in Children with Uncontrolled Moderate-to-Severe Asthma. N Engl J Med. 2021 Dec 9;385(24):2230-2240. doi: 10.1056/NEJMoa2106567.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dupilumab | Monoclonal antibody | 100 mg | Subcutaneous |
| Subject | Dupilumab | Monoclonal antibody | 200 mg | Subcutaneous |