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Article History

Received: 18 April 2025

Accepted: 3 July 2025

First Online: 28 July 2025

Declarations

:

: Carlos de Castro reports consultancy at Apellis; data safety monitoring board at Regeneron; advisory board at Omeros; honoraria from Novartis, Alexion, BioCryst, and Apellis; and research funding from Alexion and Apellis. Richard J. Kelly has received research funding from Novartis and Sobi; and consulting fees, honoraria, and speakers bureau fees from Omeros, Otsuka, Florio, Novartis, Roche, Alexion, Sobi, Jazz, and Astellas Pharmaceuticals. Morag Griffin is on the scientific advisory board for BioCryst; received honoraria for advisory boards from Alexion; and is research investigator for Alexion, Apellis, and Regeneron. Christopher J. Patriquin has received consultant fees from Alexion, Apellis, Regeneron, Takeda, BioCryst, Sobi, Amgen, and Novartis. Brian Mulherin and Regis Peffault de Latour have nothing to disclose. Britta Höchsmann consulted for Alexion, Apellis, and Novartis. Veena Selvaratnam has received consultant fees from Apellis. Raymond Siu Ming Wong has received consulting fees, honoraria, research funding, and speaker’s bureau fees from Alexion and F. Hoffmann-La Roche Ltd.; and research funding and speaker’s bureau fees from Apellis. Peter Hillmen and Uchendu O. Uchendu are employees of Apellis and hold stock options. Regina Horneff, Elena Surova, and Johan Szamosi are employees of Sobi and hold stock options or shares. Yiwei Zhang is an employee of Apellis Pharmaceuticals, Inc. and holds stock or stock options.

: All study protocols were designed and monitored in accordance with the ethical principles of Good Clinical Practice and the Declaration of Helsinki. Trials were approved by an institutional review board or independent ethics committee at each center (Table ); the master ethics committees were Advarra (PEGASUS) and Comite de Etica en Investigacion Biomedica IPS Centro Medico Julian Coronel (PRINCE). All patients provided written informed consent before participation. The trials were funded by Apellis Pharmaceuticals and Sobi (Swedish Orphan Biovitrum AB) who provided the investigative medications. The trials were registered under ClinicalTrials.gov NCT03500549 (PEGASUS), NCT04085601 (PRINCE), and NCT03531255 (307 OLE). The datasets generated and/or analyzed are available from the corresponding author on reasonable request. The FACIT and all related works are owned and copyrighted by, and the intellectual property of, David Cella, PhD. Permission for use of the FACIT-Fatigue questionnaire can be obtained by contacting Dr Cella at information@facit.org.