Clemow, David B.
Dubinsky, Marla C.
Baygani, Simin K.
Sands, Bruce E.
Keohane, Anthony
Danese, Silvio
Schreiber, Stefan
Walsh, Alissa J.
Hibi, Toshifumi
Gibble, Theresa Hunter
Moses, Richard E.
Travis, Simon P. L.
Article History
Received: 20 March 2025
Accepted: 5 June 2025
First Online: 1 July 2025
Declarations
:
: Informed consent was obtained from all participants included in these studies. This study was performed in compliance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice guidelines. Approval was granted by the ethics board that reviewed the study at each site level for each study (LUCENT-1 (NCT03518086); LUCENT-2 (NCT03524092)).
: Not applicable.
: D.B.C., SK.B., T.H.G., and R.E.M. are employees and stockholders of Eli Lilly and Company. M.C.D. reports consulting fees from AbbVie, Arena Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, F. Hoffmann-La Roche, Genentech (Roche), Gilead Sciences, Janssen, Pfizer, Prometheus Biosciences, Takeda, and UCB; contracted research from AbbVie and Janssen; stock interest in Trellus Health; and licensing fees from Takeda. B.E.S. reports consulting fees from AbbVie, Alimentiv, Amgen, Arena Pharmaceuticals, Artugen Therapeutics, AstraZeneca, Biora Therapeutics, Inc., Boehringer Ingelheim, Boston Pharmaceuticals, Calibr, Celgene, Celltrion, ClostraBio, Enthera, Equillium, Evommune, Fresenius Kabi, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Index Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Kaleido Biosciences, Kallyope, Merck & Co., Morphic Therapeutic, MRM Health, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Sun Pharma, Surrozen, Target RWE, Teva Pharmaceuticals, TLL Pharmaceuticals LLC, and Ventyx Biosciences; consulting and speaking fees from Abivax; consulting and speaking fees and other support from Eli Lilly and Company; research grants, consulting and speaking fees, and other support from Bristol Myers Squibb, Janssen, Pfizer, and Takeda; research grants and consulting fees from Theravance Biopharma; and stock options from Ventyx Biosciences. A.K. is an employee of HaaPACS GmbH, Statistics, Germany, and reports being a contractor for Eli Lilly and Company. S.D. reports consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly and Company, Enthera, Ferring Pharmaceuticals, Gilead Sciences, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB, and Vifor. S.S. reports personal fees for consulting in advisory boards from AbbVie, Amgen, Arena Pharmaceuticals, Biogen, Bristol Myers Squibb, Celgene, Celltrion, Dr. Falk Pharma, Eli Lilly and Company, Ferring, Fresenius, Galapagos, Gilead Sciences, I-Mab, Janssen, MSD, Mylan, Pfizer, Protagonist Therapeutics, Provention Bio, Sandoz/Hexal, Takeda, Theravance Biopharma, and UCB. A.J.W. reports personal fees from AbbVie, Alfasigma, Bristol Myers Squibb, Dr. Falk Pharma, Eli Lilly and Company, Ferring, Galapagos, GlaxoSmithKline, Janssen, Pfizer, Sandoz, and Takeda. T.H. reports lecture fees from AbbVie, Ferring, Gilead Sciences, Janssen, JIMRO, Kissei Pharmaceutical, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Miyarisan Pharmaceutical, Mochida Pharmaceutical, Nippon Kayaku, Takeda, and Zeria Pharmaceutical; advisory/consultancy fees from EA Pharma, Eli Lilly and Company, Janssen, Mitsubishi Tanabe Pharma, Pfizer, Takeda, and Zeria Pharmaceutical; and research grants from AbbVie, JIMRO, and Zeria Pharmaceutical. S.P.L.T. reports grants/research support from AbbVie, Buhlmann, Celgene, Eli Lilly and Company, IOIBD, Janssen, Norman Collisson Foundation, Pfizer, Takeda, UCB, and Vifor; consulting fees from Abacus Pharma, AbbVie, Actial, ai4gi, Alcimed, Allergan, Amgen, Aptel, Arena Pharmaceuticals, Asahi Kasei Pharma Corporation, Aspen Pharmacare, Astellas Pharma, AstraZeneca, Atlantic Pharma, Barco, Biocare, Biogen, BL Pharma, Boehringer Ingelheim, Bristol Myers Squibb, Buhlmann, Calico, Celgene, Cellerix, Cerimon Pharmaceuticals, ChemoCentryx, Chiesi, Cisbio, Comcast, Coronado Biosciences, Cosmo, Ducentis BioTherapeutics, Dr. Falk Pharma, Dynavax Technologies, Elan Pharmaceuticals, Eli Lilly and Company, Enterome, Ferring, FPRT Bio, Galapagos, Genentech/Roche, Genzyme, Gilead Sciences, GlaxoSmithKline, Glenmark Pharmaceuticals, GrĂ¼nenthal, GW Pharmaceuticals, Immunocore, Indigo, Janssen, Lexicon Pharmaceuticals, Medarex, Medtrix, Merck, Merrimack Pharmaceuticals, Millenium Pharmaceuticals, Neovacs, Novartis, Novo Nordisk, NPS Pharmaceuticals/Nycomed, Ocera Therapeutics, Optima Pharma, Origin, Otsuka Pharmaceutical, Palau Pharma, Pentax Medical, Pfizer, PharmaVentures, Philips, Procter & Gamble, Pronota, Proximagen, Resolute Therapeutics, Robarts, Sandoz, Santarus, Satisfai Health, Sensyne Health, Shire, Sigmoid Pharma, Souffinez, Sun Pharma, SynDermix, Synthon, Takeda, Theravance Biopharma, TiGenix, Tillotts, TopiVert Pharma, Trino Therapeutics with Wellcome Trust, TxCell, UCB, Vertex Pharmaceuticals, VHsquared, Vifor, Warner Chilcott, and Zeria Pharmaceutical; and speaker fees from AbbVie, Amgen, Biogen, Dr. Falk Pharma, Ferring, Janssen, Pfizer, Shire, Takeda, and UCB.