Burden, A. David http://orcid.org/0000-0001-7395-9931
Bissonnette, Robert http://orcid.org/0000-0001-5927-6587
Navarini, Alexander A. http://orcid.org/0000-0001-7059-632X
Murakami, Masamoto http://orcid.org/0000-0003-3923-5096
Morita, Akimichi http://orcid.org/0000-0001-8372-3754
Haeufel, Thomas
Ye, Binqi http://orcid.org/0000-0003-2276-1217
Baehner, Frank
Terui, Tadashi http://orcid.org/0000-0002-0275-4311
Funding for this research was provided by:
Boehringer Ingelheim
Article History
Received: 23 June 2023
Accepted: 2 August 2023
First Online: 20 September 2023
Declaration
:
: ADB reports receiving consulting fees from AbbVie, Almirall, BMS, Boehringer Ingelheim, Celgene, Bristol Myers Squibb, Eli Lilly, Janssen, LEO Pharma, Novartis and Union Chimique Belge (UCB) and payment or honoraria for lectures and presentations from Almirall, Boehringer Ingelheim, Eli Lilly and Janssen. RB is an advisory board member, consultant, speaker or investigator and/or received honoraria/grants from AbbVie, Almirall, AnaptysBio, Arcutis, Aristea, Bausch Health/Valeant, Boehringer Ingelheim, Boston Pharma, BMS, Dermavant, Eli Lilly, Escalier, Janssen, Kineta, Kyowa Kirin, LEO Pharma, Pfizer, Regeneron, Sienna and UCB and is also an employee and shareholder of Innovaderm Research. AAN declares being a consultant and advisor and/or receiving speaking fees/grants and/or served as an investigator in clinical trials for AbbVie, Almirall, Amgen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Galderma, GlaxoSmithKline, LEO Pharma, Janssen-Cilag, Merck Sharp & Dohme, Novartis, Pfizer, Sandoz, Sanofi, Serono and UCB. MM reports receiving research grants and/or honoraria and/or serving as an investigator in clinical trials for AbbVie, Amgen, Aristea Therapeutics, BMS, Boehringer Ingelheim, Celgene, Eisai, Eli Lilly, Janssen, Kyowa Kirin, Maruho, Novartis, Taiho and Torii. AM reports receiving research grants, consulting fees and/or speaker’s fees from AbbVie, Boehringer Ingelheim, Celgene, Eisai, Eli Lilly, Janssen, Kyowa Hakko Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe, Nichi-Iko, Nippon Kayaku, Novartis, Sun Pharmaceutical Industries, Taiho Pharmaceutical, Torii Pharmaceutical and Ushio. TT has received honoraria for speaking and consultancy from AbbVie, Eisai, Novartis, Janssen Pharmaceutical, Maruho, Taiho, Eli Lilly, BMS and Mitsubishi Tanabe Pharma. TH, BY and FB are employees of Boehringer Ingelheim. The authors met criteria for authorship as recommended by the ICMJE. The authors did not receive payment related to the development of this manuscript. Boehringer Ingelheim was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.
: The trial was conducted in compliance with the principles of the Declaration of Helsinki, in accordance with the International Council for Harmonisation Good Clinical Practice guidelines and with applicable regulatory requirements. Applicable independent ethics committees or institutional review boards at each country/participating centre (Table S1 in the ESM) reviewed the trial protocol and informed consent form and granted approval. All patients provided written informed consent prior to participation. The trial is registered on Clinicaltrials.gov: NCT04015518.