Paller, Amy S.
Wollenberg, Andreas
Siegfried, Elaine
Thaçi, Diamant
Cork, Michael J.
Arkwright, Peter D.
Gooderham, Melinda
Sun, Xian
O’Malley, John T.
Khokhar, Faisal A.
Vakil, Jignesh
Bansal, Ashish
Rosner, Karli
Shumel, Brad
Levit, Noah A. http://orcid.org/0000-0002-0797-5121
Funding for this research was provided by:
Sanofi
Regeneron Pharmaceuticals
Article History
Accepted: 23 June 2021
First Online: 31 August 2021
Declarations
:
: Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT03345914. 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/editorial assistance were provided by Vicki Schwartz, PhD, of Excerpta Medica, and was funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc., according to the Good Publication Practice guideline: ExternalRef removed.
: Amy S. Paller has served as a scientific advisor and/or clinical study investigator for AbbVie, Abeona Therapeutics, Almirall, AnaptysBio, Asana Biosciences, Boehringer Ingelheim, BridgeBio, Dermavant, Dermira, Eli Lilly, Exicure, Forté, Galderma, Incyte, InMed Pharmaceuticals, Janssen, LEO Pharma, LifeMax, Novartis, Pfizer, RAPT Therapeutics, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Sol Gel, and UCB. Andreas Wollenberg has been an investigator for Eli Lilly, Galderma, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, and UCB; has been a consultant for AbbVie, Almirall, Anacor Pharmaceuticals, Arena Pharmaceuticals, Eli Lilly, Galapagos, Galderma, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., and Sanofi Genzyme; and has received research grants from LEO Pharma and Pierre Fabre. Elaine Siegfried has served as a scientific advisor and/or clinical study investigator for Eli Lilly, Janssen, Novan, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, UCB, and Verrica Pharmaceuticals; as a paid speaker for Regeneron Pharmaceuticals, Inc.; and as a data and safety monitoring board member for GSK, LEO Pharma, Novan, Pfizer, and UCB. Diamant Thaçi has been a consultant, advisory board member, and/or investigator for AbbVie, Almirall, Amgen, Beiersdorf, Boehringer Ingelheim, Dermira, Eli Lilly, Galapagos, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, and UCB. Michael J. Cork has received research grants from Astellas Pharma, Atopix, Galopagos, Harvey Water Softeners, Hyphens Pharma, Johnson & Johnson, Kymab, L’Oréal, LEO Pharma, Novartis, Oxagen, Perrigo (ACO Nordic), Pfizer, Reckitt Benkiser, Regeneron Pharmaceuticals, Inc., and Sanofi Genzyme; has been a consultant and/or advisory board member for Astellas Pharma, Atopix, Boots, Dermavent, Galderma, Galopagos, Hyphens Pharma, Johnson & Johnson, Kymab, L’Oréal, LEO Pharma, Menlo, Novartis, Oxagen, Perrigo (ACO Nordic), Pfizer, Proctor & Gamble, Reckitt Benkiser, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, and UCB; and has served as a voluntary medical advisor to the National Eczema Society, UK. Peter D. Arkwright has served as an advisory board member for and received consulting fees and project grant funding from Sanofi Genzyme; and is an investigator for Regeneron Pharmaceuticals, Inc. Melinda Gooderham has received consulting fees/honoraria from AbbVie, Akros Pharma, Amgen, Arcutis Biotherapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Coherus BioSciences, Dermira, Eli Lilly, Galderma, GSK, Janssen, Kyowa Kirin, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Sun Pharma, UCB, and Valeant Pharmaceuticals/Bausch; has received fees for participation in review activities from AbbVie, Akros Pharma, Amgen, Arcutis Biotherapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Kyowa Kirin, LEO Pharma, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, UCB, and Valeant Pharmaceuticals/Bausch; has received payment for lectures and/or service on speakers bureaus from AbbVie, Amgen, Biosciences, Boehringer Ingelheim, Dermira, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, Sun Pharma, UCB, and Valeant Pharmaceuticals/Bausch; and has served as an investigator, advisor, and/or speaker for AbbVie, Akros Pharma, Amgen, Arcutis Biotherapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Coherus BioSciences, Dermira, Eli Lilly, Galderma, GSK, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Roche, Sanofi Genzyme, Sun Pharma, UCB, and Valeant Pharmaceuticals/Bausch. Xian Sun, Faisal A. Khokhar, Ashish Bansal, Brad Shumel, and Noah A. Levit are employees and shareholders of Regeneron Pharmaceuticals, Inc. John T. O’Malley and Jignesh Vakil are employees of and may hold stock and/or stock options in Sanofi. Karli Rosner is an employee of and may hold stock and/or stock options in Sanofi Genzyme.
: 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 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.
: The study was conducted following the ethical principles that derive from the Declaration of Helsinki, International Council for Harmonisation guidelines, Good Clinical Practice guideline, 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.
: The authors affirm that written consent was obtained from parents or legal guardians for publishing study information and results.
: AB, KR, BS, and NAL contributed to study concept and design. ASP, AW, ES, DT, MJC, PDA, and MG acquired data. XS conducted the statistical analyses on the data. KR and NAL drafted the manuscript with the medical writer and created figures. 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.
: Not applicable.