Siegfried, Elaine C.
Bieber, Thomas http://orcid.org/0000-0002-8800-3817
Simpson, Eric L.
Paller, Amy S. http://orcid.org/0000-0001-6187-6549
Beck, Lisa A. http://orcid.org/0000-0002-8452-667X
Boguniewicz, Mark
Schneider, Lynda C. http://orcid.org/0000-0002-5633-0178
Khokhar, Faisal A.
Chen, Zhen
Prescilla, Randy http://orcid.org/0000-0001-7672-5460
Mina-Osorio, Paola http://orcid.org/0000-0003-2986-9642
Bansal, Ashish http://orcid.org/0000-0002-7371-6486
Funding for this research was provided by:
Sanofi
Regeneron Pharmaceuticals
Article History
Accepted: 16 December 2020
First Online: 3 March 2021
Declarations
:
: This research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. (ClinicalTrials.gov identifier: NCT03054428). 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 were provided by Alexandre Houzelle, PhD, and Vicki Schwartz, PhD, of Excerpta Medica, funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc.
: Elaine C. Siegfried: Dermavant, Eli Lilly, Pfizer, Regeneron Pharmaceuticals, Inc., Verrica—consultant; GlaxoSmithKline, LEO Pharma, Novan, Pfizer—data and safety monitoring board; Eli Lilly, Janssen, Regeneron Pharmaceuticals, Inc., Stiefel, Verrica—Principal Investigator in clinical trials. Thomas Bieber: AbbVie, Almirall, AnaptysBio, Arena, Asana Biosciences, Astellas, BioVersys, Boehringer Ingelheim, Daichi Sankyo, Davos Biosciences, Dermavant/Roivant Sciences, DS Pharma, Eli Lilly, Evaxion Biotech, FLX Bio, Galapagos/MorphoSys, Galderma, Glenmark, GlaxoSmithKline, Incyte, Kymab, LEO Pharma, L´Oréal, Menlo Therapeutics, Novartis, Pfizer, Pierre Fabre, Sanofi/Regeneron Pharmaceuticals, Inc., UCB—lecturer and/or consultant. Eric L. Simpson: AbbVie, Celgene, Eli Lilly, Galderma, Kyowa Hakko Kirin, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Tioga—grants; AbbVie, Boehringer Ingelheim, Dermavant, Dermira, Eli Lilly, Forte Bio, Incyte, LEO Pharma, MedImmune, Menlo Therapeutics, Ortho Dermatologics, Pfizer, Pierre Fabre Dermo Cosmetique, Regeneron Pharmaceuticals, Inc., Sanofi, Valeant—personal fees. Amy S. Paller: AbbVie, AnaptysBio, Celgene, Eli Lilly, Galderma, Incyte, KrystalBio, LEO Pharma, Janssen, Novartis, Regeneron Pharmaceuticals, Inc.—investigator; AbbVie, Abeona Therapeutics, Almirall, Amgen, Asana Biosciences, Boehringer Ingelheim, Dermavant, Dermira, Eli Lilly, Exicure, Forte, Galderma, Janssen, LEO Pharma, Novartis, Pfizer, RAPT Therapeutics, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Sol Gel, UCB—consultant with honorarium. Lisa A. Beck: AbbVie, Allakos, Arena Pharma, AstraZeneca, BenevolentAI, Connect Biopharma, Eli Lilly, Incyte, LEO Pharma, Novartis, Pfizer, Principia Biopharma, RAPT Therapeutics, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Vimalan—consultant. AbbVie, LEO Pharma, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi—investigator; 3M, Gilead, Medtronics, Moderna—owns stocks. Mark Boguniewicz: Regeneron Pharmaceuticals, Inc.—investigator; Regeneron Pharmaceuticals, Inc., Sanofi Genzyme—consultant. Lynda C. Schneider: Regeneron Pharmaceuticals, Inc., DBV Technologies—investigator; Genentech—research support; AbbVie—consultant. Faisal A. Khokhar, Zhen Chen, Paola Mina-Osorio, Ashish Bansal: Regeneron Pharmaceuticals, Inc.—employees and shareholders. Randy Prescilla: Sanofi Genzyme—employee, may hold stock and/or stock options in the company.
: The study was conducted following the ethical principles that derive from the Declaration of Helsinki, International Conference on Harmonization guidelines, Good Clinical Practice, and local applicable regulatory requirements. The trial was overseen by an independent data and safety monitoring board.
: Written informed consent was obtained from all patients and the patients’ parents/guardians prior to commencement 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, 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 re-identification. Submit requests to ExternalRef removed.
: Not applicable.
: AB contributed to study concept and design. ECS, TB, ELS, ASP, LAB, MB, and LCS acquired data. ZC conducted the statistical analyses on the data. AB drafted the manuscript with the medical writer and created figures. ECS, TB, ELS, ASP, LAB, MB, LCS, FAK, ZC, RP, PM-O, and AB 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.