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Article History

Received: 6 June 2025

Accepted: 12 October 2025

First Online: 11 November 2025

Declarations

:

: Brian S. Kim is a co-founder of Alys Pharmaceuticals, reported acting as a consultant for 23andMe, Abrax Japan, AbbVie, Almirall, Amagma, Amgen, Arcutis Biotherapeutics, Arena Pharmaceuticals, Argenx, AstraZeneca, Bellus Health, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Clexio Biosciences, CymaBay Therapeutics, Eli Lilly, Escient Pharmaceuticals, Evommune, Galderma, Genentech, Granular Therapeutics, GSK, Guidepoint Global, Incyte, Innovaderm Research, Janssen Pharmaceuticals, Kiniksa Pharmaceuticals, LEO Pharma, Medicxi, Micreos, Novartis, OM Pharma, Pfizer, RecensMedical, Regeneron Pharmaceuticals Inc., Sanofi, Septerna, Shaperon, Teva, Third Harmonic Bio, Third Rock Ventures, Trevi Therapeutics, Triveni, Vial, and WebMD; reported serving as an advisory board member for Cara Therapeutics, Celgene, Kiniksa Pharmaceuticals, Menlo Therapeutics, Regeneron Pharmaceuticals Inc., Sanofi, and Theravance Biopharma; is a stockholder in Abrax Japan, Klirna Biotech, Locus Biosciences, Nuogen Pharma, and RecensMedical; is a patent holder for the use of Janus kinase 1 inhibitors for chronic pruritus (patent pending for the use of Janus kinase inhibitors for interstitial cystitis); is the founder of and chief scientific officer at Nuogen Pharma; and reports research grants from Cara Therapeutics and LEO Pharma. Margarida Gonçalo reported serving as an advisory board member and/or speaker at AbbVie, Almirall, AstraZeneca, LEO Pharma, Lilly, Novartis, Pfizer, Sanofi, and Takeda. Tsukasa Ugajin reported giving lectures for AbbVie, Kaken, Kyorin Pharmaceutical, Maruho, Mitsubishi Tanabe Pharma, Novartis, Sanofi, Taiho, and Takeda. Xing-Hua Gao reported serving as an investigator with AbbVie, Boehringer Ingelheim, Novartis, Pfizer, and Sanofi; as a consultant and advisory board member with AbbVie, AstraZeneca, BMS, Eli Lilly, Huarun, JiaLan, LEO Pharma, Pfizer, Puqi, and Sanofi; and as a speaker for Eli Lilly, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals Inc., and Sanofi. Amy H. Praestgaard, Simmi Wiggins, and Melanie Makhija are employees of Sanofi, and may hold stock and/or stock options in the company. Joseph Zahn and Ashish Bansal are employees and shareholders of Regeneron Pharmaceuticals Inc.

: This study was conducted in accordance with ethical standards of the responsible committees and the Declaration of Helsinki 1964 and its later amendments, and with the International Council for Harmonisation guidelines for Good Clinical Practice. The trial was overseen by an independent data and safety monitoring board. The protocol was reviewed and approved by institutional review boards/ethics committees at all centers. All patients provided written informed consent before participating in the trial.

: Written informed consent was obtained from all patients or their proxies.

: Not applicable.

: Qualified researchers may request access to patient-level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient-level data will be anonymized, and study documents will be redacted to protect the privacy of our trial participants. Further details on Sanofi’s data-sharing criteria, eligible studies, and process for requesting access can be found at: .

: Not applicable.

: SW and JZ had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors contributed to the study concept and design and all participated in the acquisition, analysis, or interpretation of data. All authors participated in the drafting of the manuscript and critical revision of the manuscript for important intellectual content. AHP performed the statistical analysis. SW and JZ were responsible for study supervision.