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Article History

Received: 27 March 2026

Accepted: 17 July 2026

First Online: 1 September 2026

Declarations

Conflict of Interest: Jan Noukens acted as a consultant paid by argenx. Anthony D. Andre is an employee of and shareholder in Interface Analysis Associates LLC. Cassandra De Muynck, Filip Borgions, Koen Allosery, Clotilde Cettour-Rose, and Ségolène Pastouret are employees of argenx.

Ethical Approval: The bioequivalence study and the injection speed study were conducted in accordance with consensus ethical principles derived from international guidelines, including the Declaration of Helsinki 1964 and its later amendments and the Council for International Organizations of Medical Sciences international ethical guidelines, applicable ICH Good Clinical Practice guidelines, and local laws and regulations. IRB approval for the bioequivalence study was granted by Advarra (Columbia, MS, US; approval no. Pro00074818, October 10, 2023). IRB approval for the injection speed study was granted by Advarra (Columbia, MD, USA; approval no. Pro00072919). The HF studies were designed in accordance with the US Food and Drug Administration Application of Human Factors Engineering Principles for Combination Products: Questions and Answers; Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications; and Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development guidelines. All participants provided informed consent before participation. All study documents, including the recruiting screener, informed consent form, and any other requested documents, were reviewed and approved by Salus IRB (Austin, TX, USA; approval nos IAA-2342 and IAA-2401, December 11, 2023, and December 14, 2023, respectively) before conducting these studies.