Pandya, Amit G. http://orcid.org/0000-0002-3916-2651
Amoloja, Theresa http://orcid.org/0009-0007-9629-1891
Bibeau, Kristen http://orcid.org/0000-0002-6871-2333
DiBenedetti, Dana http://orcid.org/0000-0003-2294-9519
Kosa, Katherine http://orcid.org/0000-0002-6461-527X
Butler, Kathleen http://orcid.org/0000-0002-6907-0846
Kornacki, Deanna http://orcid.org/0000-0001-6286-2069
Ezzedine, Khaled http://orcid.org/0000-0002-5468-4589
Funding for this research was provided by:
Incyte
Article History
Received: 21 May 2024
Accepted: 16 July 2024
First Online: 5 August 2024
Declarations
:
: Amit G. Pandya has served as an investigator for Aclaris Therapeutics, Immune Tolerance Network, Incyte Corporation, and Pfizer and a consultant for AbbVie, Arcutis, Avita Medical, Immune Tolerance Network, Incyte Corporation, Pfizer, Thalocan, TWi, Viela Bio, Vimela, Villaris, Vyne and WCG/Trifecta, and holds stock options for Tara Medical and Zerigo Health. Theresa Amoloja and Deanna Kornacki are employees and shareholders of Incyte Corporation. Kristen Bibeau (currently an employee at Moderna) and Kathleen Butler (currently an employee at Astria Therapeutics) were employees of Incyte Corporation at the time of the study and are shareholders of Incyte Corporation. Dana DiBenedetti and Katherine Kosa are employees of RTI Health Solutions, which was contracted by Incyte Corporation to conduct interviews with participants identified by a recruiting firm (Study 2). Khaled Ezzedine is a consultant for AbbVie, Incyte Corporation, La Roche-Posay, Pfizer, Pierre Fabre, Sanofi, and Viela Bio.
: The TRuE-V1/TRuE-V2 study protocols (Study 1) were approved by the Western Institutional Review Board and an institutional review board or ethics committee at participating centers. Trials were conducted in accordance with the Declaration of Helsinki and adhered to study protocols, Good Clinical Practice, and applicable country-specific laws and regulations. Written informed consent or assent was provided by all patients. Study 2 was performed in accordance with the Declaration of Helsinki and in adherence to the study protocol and local regulatory requirements. Prior to the start of each interview, participants provided verbal informed consent (for adult interviewees) or assent with parental permission (for adolescent participants) and could withdraw consent at any time. The study protocol was approved by the RTI Institutional Review Board.
: The authors thank the patients and their families for their participation in the TRuE-V1 and TRuE-V2 studies, including those who agreed to be interviewed for Study 1, and the individuals who participated in the interviews in Study 2.