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Article History

Accepted: 30 June 2024

First Online: 29 July 2024

Declarations

:

: This study (MOM-M281-010) was sponsored by Momenta Pharmaceuticals. Nipocalimab is being developed by Janssen Research & Development, LLC.

: Nobuko Matsushima, Sayori Shibata, Jocelyn H. Leu, An Vermeulen, Leona E. Ling, and Lisa B. Schwartz are employees of Janssen Research & Development, LLC and hold stock/stock options from Johnson & Johnson. Jay Duffner was an employee of Janssen Research & Development, LLC at the time of the study. Hideo Harigae has served on an advisory board for Janssen.

: This study was reviewed by an independent institutional review board, Advarra, Inc. (Austin, TX, USA), and conducted in accordance with Good Clinical Practice, as defined by the International Council for Harmonisation Harmonised Tripartite Guideline regarding Good Clinical Practice (E6 Consolidated Guidance, April 1996, and Integrated Addendum to ICH E6, November 2016) and in accordance with the ethical principles underlying European Union Directive 2001/20/EC and set forth in the Declaration of Helsinki. The protocols, amendments, and volunteer informed consent received appropriate approval by the institutional review board/independent ethics committee prior to the initiation of the study at the site.

: Prior to initiation of any study-specific procedures, all volunteers received a copy of the informed consent form that summarized, in non-technical terms, the purpose of the study, the procedures to be carried out, and the potential hazards. All volunteers reviewed, signed, and dated the informed consent.

: Not applicable.

: The data-sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at . Requests from any qualified researchers who engage in rigorous, independent scientific research will be considered if the trials are not part of an ongoing or planned regulatory submission (this includes requests for data on unlicensed products and indications). Data will be provided after review and approval of a research proposal or statistical analysis plan, confirmation that the requested data can be shared under applicable privacy laws, and execution of a data-sharing agreement. Requests can be sent to the corresponding author.

: Not applicable.

: All authors were involved in the critical revisions of the manuscript and review for important content and were accountable for all aspects of the work (accuracy and integrity), and approved the final manuscript submitted. NM: conceptualization, formal analysis, writing – review and editing. SS: formal analysis, writing – review and editing. JHL: formal analysis, visualization, supervision, project administration, writing – review and editing. AV: formal analysis, supervision, project administration, writing – review and editing. JD: formal analysis, data curation, software, methodology, writing – review and editing. LEL: conceptualization, methodology, visualization, writing – review and editing. LBS: conceptualization, formal analysis, investigation, resources, supervision, writing – review and editing. HH: supervision, writing – review and editing.