Giménez-Arnau, Ana M.
Casale, Thomas B.
Yosipovitch, Gil
Ensina, Luis Felipe
Inomata, Naoko
Msihid, Jérôme
Makhija, Melanie
Radin, Allen
Cyr, Sonya L.
Sugerman, Philip
Thomas, Ryan B.
Chuang, Chien-Chia
Clinical trials referenced in this document:
Documents that mention this clinical trial
Dupilumab Reduces Urticaria Activity, Itch, and Hives in Patients with Chronic Spontaneous Urticaria Regardless of Baseline Serum Immunoglobulin E Levels
https://doi.org/10.1007/s13555-024-01231-y
Dupilumab Improves Health-Related Quality of Life in Omalizumab-Naïve Patients with Chronic Spontaneous Urticaria
https://doi.org/10.1007/s13555-025-01605-w
Funding for this research was provided by:
Sanofi
Regeneron Pharmaceuticals
Article History
Received: 22 September 2025
Accepted: 12 November 2025
First Online: 2 December 2025
Declarations
:
: Ana M. Giménez-Arnau has received research support from Instituto Carlos III FEDER, Novartis, and Uriach Pharma; has been a medical advisor for Almirall, Amgen, Celldex Therapeutics, Celltrion, Escient Pharmaceuticals, Faes Farma, Genentech, GSK, LEO Pharma, Mitsubishi Tanabe Pharma, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, Servier, Thermo Fisher Scientific, and Uriach/Noucor; and has been involved in educational activities for Almirall, Avène, Genentech, GSK, LEO Pharma, Menarini, MSD, Novartis, Sanofi, and Uriach. Thomas B. Casale has received research support from the American Lung Association, Genentech, NIH, Novartis, PCORI, and Sanofi; has been a consultant for AstraZeneca, Boehringer Ingelheim, Genentech, Novartis, and Regeneron Pharmaceuticals Inc.; and served on the speakers’ bureau for Genentech. Gil Yosipovitch has been an advisory board member for AbbVie, Almirall, Amgen, Arcutis, Celldex, Eli Lilly, Escient Health, Galderma, GSK, LEO Pharma, Merck, Novartis, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals Inc., Sanofi, and Vifor; has received grants/research funding from Eli Lilly, Escient, Galderma, Kiniksa, LEO Pharma, Novartis, Pfizer, Sanofi Celldex, and Sanofi-Regeneron Pharmaceutical Inc.; and has been an investigator for Galderma, Regeneron Pharmaceuticals Inc., and Sanofi. Gil Yosipovitch is an editorial board member of the Dermatology and Therapy journal. Gil Yosipovitch was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Luis Felipe Ensina has been reported as a speaker and/or consultant for AbbVie, Novartis, and Sanofi. Naoko Inomata has received institutional grants from AbbVie, Daiichi Sankyo, Eli Lilly, KAKEN, KYORIN, Maruho, Taiho Pharmaceutical, and Torii; and has been a consultant and/or has received honoraria for/from Maruho, Mitsubishi Tanabe, Sanofi, Taiho Pharmaceutical, Takeda, Torii, and UCB. Jérôme Msihid, Melanie Makhija, Philip Sugerman, and Chien-Chia Chuang are employees of Sanofi and may hold stock and/or stock options in the company. Allen Radin, Sonya L. Cyr, and Ryan B. Thomas are employees and shareholders of Regeneron Pharmaceuticals Inc.
: The study was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Good Clinical Practice guideline, 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 [IRB]/independent ethics committee)-approved standard practice for pediatric patients at each participating center.