Funding

This research was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. (ClinicalTrials.gov Identifiers: NCT02612454 and NCT03346434 part B). The study sponsors participated in the study design; the collection, analysis, and interpretation of the data; the writing of the report; and the decision to submit the article for publication. Medical writing/editorial assistance was provided by Ekaterina Semenova, PhD, and Vicki Schwartz, PhD, of Excerpta Medica, funded by Sanofi and Regeneron Pharmaceuticals Inc., according to the Good Publication Practice guideline.

Availability of Data and Material

Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, and statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data, and there is not a reasonable likelihood of participant reidentification. Submit requests to https://vivli.org.

Conflicts of Interest

Amy S. Paller is an investigator for AbbVie, Dermavant, Eli Lilly, Incyte, Janssen, Krystal Biotech, LEO Pharma, and UCB; a consultant for Amryt Pharma, Azitra, BioCryst, BMS, Boehringer Ingelheim, Castle Creek Biosciences, Eli Lilly, InMed Pharmaceuticals, Janssen, Krystal Biotech, LEO Pharma, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, Seanergy, TWI Biotechnology, and UCB; and a member of the data safety monitoring board for AbbVie, Abeona, Catawba Research, Galderma, and InMed Pharmaceuticals. Elaine C. Siegfried is a consultant for Regeneron Pharmaceuticals Inc., Sanofi, and Verrica Pharmaceuticals; a member of the data safety monitoring board for Esperare, LEO Pharma, Novan, Pfizer, and UCB; and a principal investigator in clinical trials for Amgen, Regeneron Pharmaceuticals Inc., and Sanofi. Eric L. Simpson has received personal fees from AbbVie, Boehringer Ingelheim, Collective Acumen, Eli Lilly, Forté Biosciences, Incyte, Janssen, Kyowa Hakko Kirin, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Pierre Fabre Dermo-Cosmetics, Regeneron Pharmaceuticals Inc., Roivant Sciences, Sanofi, and Valeant; and has received grants/is a principal investigator for AbbVie, Eli Lilly, Incyte, Kyowa Hakko Kirin, LEO Pharma, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi, Tioga Pharmaceuticals, and Vanda Pharmaceuticals. Michael J. Cork is 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. Robert Sidbury is an investigator for Castle Creek Biosciences, Galderma, Pfizer, Regeneron Pharmaceuticals Inc., and UCB; an advisory board member for Pfizer; a consultant for Eli Lilly, LEO Pharma, and Micreos; and is in a speaker’s bureau for Beiersdorf. Iris H. Chen and Ariane Dubost-Brama are employees of Sanofi and may hold stock and/or stock options in the company. Faisal A. Khokhar, Jing Xiao, and Ashish Bansal are employees and shareholders of Regeneron Pharmaceuticals Inc.

Authors’ Contributions

A.B. contributed to the study conception and design; A.S.P., E.C.S., E.L.S., M.J.C., and R.S. contributed to the acquisition of data; and I.H.C. and J.X. contributed to the statistical analysis of the data. All authors contributed to the interpretation of data, commented on previous versions of the manuscript, and read and approved the final manuscript.

Ethics Approval

The study was conducted following the ethical principles derived from the Declaration of Helsinki, the International Conference on Harmonisation guidelines, Good Clinical Practice, and local applicable regulatory requirements. Written informed consent was obtained from all patients and the patients’ parents/guardians prior to commencement of any study treatment. At each study site, the protocol, informed-consent form (ICF), and patient information were approved by an institutional review board and independent ethics committee.

Consent to Participate

All patients provided written consent/assent, and at least one parent or guardian for each adolescent patient provided written informed consent. All people named in the Acknowledgements section gave written permission to be named in the manuscript.

Consent for Publication

Not applicable.

Code Availability

Not applicable.