Funding

This research was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. ClinicalTrials.gov Identifier: NCT03346434. 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. Medical writing and editorial assistance was provided by Alessandra Iannino, PhD, of Excerpta Medica, and was funded by Sanofi and Regeneron Pharmaceuticals Inc., according to the Good Publication Practice Guidelines. https://doi.org/10.7326/M22-1460.

Competing Interests

Dr Paller reported serving as an investigator, consultant, and/or data and safety monitoring board member for AbbVie, Abeona Therapeutics, Amryt Pharma, Azitra, BioCryst, BMS, Boehringer Ingelheim, Castle Creek Biosciences, Catawba Research, Dermavant, Eli Lilly, Galderma, Incyte, InMed Pharmaceuticals, Janssen, Krystal Biotech, LEO Pharma, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, Seanergy, TWi Biotechnology, and UCB. Dr Siegfried reported serving as a consultant, data safety monitoring board member, and/or principal investigator in clinical trials for Dermavant, Eli Lilly, GSK, Janssen, LEO Pharma, Novan, Pfizer, Regeneron Pharmaceuticals Inc., Stiefel, and Verrica Pharmaceuticals. Dr Cork reported serving as 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. Dr Arkwright reported acting as an investigator for Regeneron Pharmaceuticals Inc. and receiving grants from and acting as an advisor for Sanofi. Dr Eichenfield reported receiving honoraria for consulting services and/or research support from AbbVie, Amgen, Arcutis, Aslan, Bausch, BMS, Castle Biosciences, Dermavant, Eli Lilly, Forté Pharma, Galderma, Incyte, Novartis, Otsuka, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi, and UCB. Dr Ramien reported serving as a consultant, speaker, and/or investigator for AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron Pharmaceuticals Inc., and Sanofi. Drs Khokhar, Chen, and Cyr are employees and shareholders of Regeneron Pharmaceuticals Inc. Dr Zhang is an employee of and may hold stock and/or stock options in Sanofi.

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 product and indication have been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification. Submit requests to https://vivli.org/.

Ethics Approval

The study was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Good Clinical Practice guidelines, and applicable regulatory requirements. An independent data and safety monitoring committee conducted blinded monitoring of patient safety data. The local institutional review board or ethics committee at each study center oversaw trial conduct and documentation. All patients, or their parents/guardians, provided written informed consent before participating in the trial. Pediatric patients provided assent according to the Ethics Committee (Institutional Review Board/Independent Ethics Committee)-approved standard practice for pediatric patients at each participating center.

Consent to Participate

For each patient, written informed consent was obtained from a parent or legal guardian.

Consent for Publication

Not applicable.

Code Availability

Not applicable.

Author Contributions

A.S. Paller, E.C. Siegfried, M.J. Cork, and P.D. Arkwright acquired data. Z. Chen 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 manuscript.