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Article History

Accepted: 6 December 2022

First Online: 19 December 2022

Change Date: 3 March 2023

Change Type: Update

Change Details: A peer-reviewed video abstract was retrospectively added to this publication.

Declarations

:

: This research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT03346434, part B. The study sponsors participated in the study design; collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the article for publication. The study sponsors paid the open access fee. The National Institute for Health and Care Research provided support to The Manchester Clinical Research Facility at Royal Manchester Children’s Hospital in Manchester, UK.

: A.S.P. reports being an investigator for AbbVie, Eli Lilly, Incyte, and Regeneron Pharmaceuticals, Inc.; a consultant with honorarium for AbbVie, Almirall, Arcutis Biotherapeutics, Arena Pharmaceuticals, BiomX, Bristol Myers Squibb, Catawba Research, Eli Lilly, Galderma, Gilead, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, RAPT Therapeutics, Regeneron Pharmaceuticals, Inc., Sanofi, and Seanergy; and on a data safety monitoring board for Bausch Health and Galderma. E.C.S. reports being a consultant for AbbVie, Amgen, Eli Lilly, Gilead, Incyte, Novan, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals, Inc., Sanofi, and Verrica Pharmaceuticals; on a data and safety monitoring board for LEO Pharma, Novan, Pfizer, and UCB; and a Principal Investigator in clinical trials for Eli Lilly, Janssen, Regeneron Pharmaceuticals, Inc., and Verrica Pharmaceuticals. M.J.C. reports being an investigator and/or consultant for AbbVie, Astellas Pharma, Boots, Dermavant, Galapagos, Galderma, Hyphens Pharma, Johnson & Johnson, LEO Pharma, L’Oréal, Menlo Therapeutics, Novartis, Oxagen, Pfizer, Procter & Gamble, Reckitt Benckiser, Regeneron Pharmaceuticals, Inc., and Sanofi. A.W. reports being an investigator for Beiersdorf, Eli Lilly, Galderma, LEO Pharma, MedImmune, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., and Sanofi; a consultant for AbbVie, Aileens Pharma, Almirall, Anacor Pharmaceuticals, Eli Lilly, Galapagos, Galderma, GSK, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., and Sanofi; and receiving research grants (to the institution) from Beiersdorf, LEO Pharma, and Pierre Fabre. P.D.A. reports being an investigator for Regeneron Pharmaceuticals, Inc.; and receiving a research grant from, and being an advisor for Sanofi. M.E.G. reports being an investigator for AbbVie, Arcutis Biotherapeutics, Dermira, Dermavant, Eli Lilly, Incyte, Krystal Biotech, Regeneron Pharmaceuticals, Inc., Sun Pharma, and Verrica Pharmaceuticals; a speaker for Galderma, Pfizer, Primus Pharmaceuticals, Regeneron Pharmaceuticals, Inc., and Sanofi; and a consultant for Noble Pharma, Unilever, and Verrica Pharmaceuticals. B.L. reports being an investigator and a speaker for Eli Lilly and Regeneron Pharmaceuticals, Inc.; an investigator for Anacor Pharmaceuticals, Dermira, Franklin Bioscience, and LEO Pharma; an investigator, speaker, and consultant for AbbVie; and a speaker, consultant, and researcher for Incyte. Z.C., A.B., and N.A.L. are employees and shareholders of Regeneron Pharmaceuticals, Inc. R.P. is an employee of Sanofi and may hold stock and/or stock options in the company.

: The study was conducted following the ethical principles derived from the Declaration of Helsinki, the International Council for Harmonisation guidelines, Good Clinical Practice, and local applicable regulatory requirements. Local institutional review boards or ethics committees at each trial center oversaw trial conduct and documentation and reviewed and approved the study protocol. A full list of investigators and their affiliations are provided in Reference 19 (Paller AS, Simpson EL, Siegfried EC, Cork MJ, Wollenberg A, Arkwright PD, et al. 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;400(10356):908–19. ).

: Written informed consent was obtained from the patients’ parents/guardians prior to the start of any study treatment.

: Not applicable.

: Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in this article. Individual anonymized participant data will be considered for sharing once the product and indication has been approved by major health authorities (e.g., US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency), if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification. Submit requests to .

: Not applicable.

: ASP, ECS, MJC, AW, PDA, MEG, and BL acquired the data. ZC conducted the statistical analyses on the data. All authors interpreted the data, provided critical feedback on the manuscript, approved the final manuscript for submission, and are accountable for the accuracy and integrity of the article.