Prevention and interception trials in inflammatory bowel disease: an international taskforce assessment on clinical trial design
- PMID: 40187359
- DOI: 10.1016/S2468-1253(24)00439-4
Prevention and interception trials in inflammatory bowel disease: an international taskforce assessment on clinical trial design
Abstract
Therapeutic progress in inflammatory bowel disease (IBD) has hitherto focused on reducing inflammation to minimise long-term complications. However, strategies aimed at preventing IBD and attenuating its disease course are particularly appealing. This concept is derived from accumulating evidence for an "at-risk" preclinical state and the associations linking genetic background and numerous environmental exposures to disease pathogenesis. Trials in rheumatoid arthritis and type 1 diabetes have identified interventions to delay disease onset, modify the subsequent disease course (potentially protecting against irreversible tissue and end organ damage), and prolong normal quality of life. Prevention and interception trials have major challenges compared with therapeutic trials across a number of domains, including ethical considerations, eligibility criteria, sample size, and optimal endpoints. This Review investigates important factors in designing high-quality prevention trials and evaluates the feasibility and current progress of such trials in IBD, aiming to identify therapeutic strategies for populations at risk.
Copyright © 2025 Elsevier Ltd. All rights reserved.
Conflict of interest statement
Declaration of interests SH served as a speaker, a consultant, an advisory board member, or received travel grants from Pfizer, Janssen, AbbVie, Takeda, Ferring, Lilly, Alfasigma, Banook Group, and Pharmacosmos. JT received grant support from AbbVie and Janssen; advisory board fees or speaker fees from for AbbVie, Pfizer, Lilly, Sandoz, Tillots, and Janssen; and support for meetings or travel, or both, from AbbVie and Janssen. KC received honoraria for speaking or as an advisor for Ferring, Janssen, AbbVie, Takeda, Pfizer, Altrubio, Goodcap, and Microbiome Insights; and received research support from Janssen and AbbVie. RCU served as a consulting or advisory board member for AbbVie, Bristol Myers Squibb, Celltrion, Genentech, Janssen, Lilly, Pfizer, Roivant, and Takeda; and received research support from AbbVie, Boehringer Ingelheim, Lilly, and Pfizer. MA is supported by the National Institute of Diabetes and Digestive and Kidney Diseases (K23DK129762-03), and reports consulting free from Douglas Pharmaceutical. DT received consultation fees, research grants, royalties, or honoraria from Janssen, Pfizer, the Hospital for Sick Children, Ferring, AbbVie, Takeda, Biogen, Neopharm Group, Uniliver, Atlantic Health, Shire, Celgene, Lilly, and Roche. ID received consultation fees, research grants, or honoraria from Janssen, Pfizer, AbbVie, Takeda, Genentech/Roche, Ferring, Iterative Scopes, Integra Holdings, Lilly, Falk Pharma, Gilead, Galapagos, Celgene/Bristol Myers Squibb, Arena, Sublimity, Sangamo, Sandoz, Celltrion, Abbott, Prometheus, Altman, and Athos; and is a shareholder for Harp Diagnostics and GUTREAT. GD'H served as advisor or received speaker fees from AbbVie, Agomab Therapeutics, Alimentiv, AstraZeneca, Bristol Meiers Squibb, Cytoki, Celltrion, Lilly, Exeliom Biosciences, Ferring, Galapagos, GlaxoSmithKline, Pfizer, Polpharm, Immunic, Index Pharmaceuticals, Johnson & Johnson, Merck, ProciseDx, Seres Health, Takeda, Tillotts, and Ventyx. DTR reports speaker or consultant fees from AbbVie, Abgenomics, Allergan, Arena Pharmaceuticals, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Bristol Meiers Squibb, CDx Diagnostics, Syneos, Check-Cap, Dizal Pharmaceuticals, Genentech/Roche, Gilead Sciences, Ichnos Sciences, InDex Pharmaceuticals, Iterative Scopes, Janssen, Lilly, Materia Prima, Narrow River Management, Pfizer, Prometheus Laboratories, Reistone, Takeda, and Techlab; and research grants from Takeda. SCN served as an advisory board member for Pfizer, Ferring, Janssen and AbbVie; received honoraria as a speaker for Ferring, Tillotts, Menarini, Janssen, AbbVie, and Takeda; received research grants through her affiliated institutions from Olympus, Ferring, and AbbVie; is a founder member, non-executive director, non-executive scientific advisor, and shareholder of GenieBiome; receives patent royalties through her affiliated institutions and is a named inventor of patent applications held by the Chinese University of Hong Kong and MagIC that include the therapeutic and diagnostic use of microbiome. RG received honoraria for speaking and advisory board roles from AbbVie, Janssen, Takeda, Celltrion, and Zespri. VJ received consulting or advisory board fees from AbbVie, Alimentiv, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris, AstraZeneca, Bristol Myers Squibb, Celltrion, Lilly, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Metacrine, Mylan, Pandion, Pendopharm, Pfizer, Protagonist, Prometheus, Reistone Biopharma, Roche, Sandoz, Second Genome, Sorriso Pharmaceuticals, Takeda, Teva, Topivert, Ventyx, and Vividion; and speaker fees from AbbVie, Ferring, Bristol Myers Squibb, Galapagos, Janssen, Pfizer, Shire, Takeda, and Fresenius Kabi. SD served as a speaker, consultant, and advisory board member for Schering–Plough, AbbVie, Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring, Genentech, Grunenthal, Johnson & Johnson, Millenium Takeda, Merck Sharp Dohme, Nikkiso Europe, Novo Nordisk, Nycomed, Pfizer, Pharmacosmos, UCB Pharma, and Vifor. J-FC reports research grants from AbbVie, Janssen Pharmaceuticals, Takeda, and Bristol Myers Squibb; payment for lectures from AbbVie and Takeda; consulting fees from AbbVie, Amgen, AnaptysBio, Allergan, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Celgene Corporation, Celltrion, Lilly, Ferring Pharmaceuticals, Galmed Research, GlaxoSmithKline, Genentech/Roche, Janssen Pharmaceuticals, Kaleido Biosciences, Immunic, Invea, Iterative Scopes, Merck, Landos, Microba Life Science, Novartis, Otsuka Pharmaceutical, Pfizer, Protagonist Therapeutics, Prometheus, Sanofi, Seres, Takeda, Teva, TiGenix, and Vifor; and has stock options in Intestinal Biotech Development. LP-B reports consulting fees from AbbVie, Abivax, Adacyte, Alimentiv, Amgen, Applied Molecular Transport, Arena, Banook, Biogen, Bristol Myers Squibb, Celltrion, Connect Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GlaxoSmithKline, IAC Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, Merck Sharp Dohme, Nordic Pharma, Novartis, Oncodesign Precision Medicine, ONO Pharma, OSE Immunotherapeutics, Pandion Therapeutics, Par' Immune, Pfizer, Prometheus, Protagonist, Roche, Samsung, Sandoz, Sanofi, Satisfay, Takeda, Telavant, Theravance, Thermo Fischer, Tigenix, Tillots, Viatris, Vectivbio, Ventyx, and Ysopia; reports grants from Celltrion, Fresenius Kabi, Medac, Merck Sharp Dohme, and Takeda; lecture fees from AbbVie, Amgen, Arena, Biogen, Celltrion, Ferring, Galapagos, Genentech, Gilead, Janssen, Lilly, Medac, Merck Sharp Dohme, Nordic Pharma, Pfizer, Sandoz, Takeda, Tillots, and Viatris; and reports travel support from AbbVie, Amgen, Celltrion, Connect Biopharm, Ferring, Galapagos, Genentech, Gilead, Gossamer Bio, Janssen, Lilly, Medac, Morphic, Merck Sharp Dohme, Pfizer, Sandoz, Takeda, Thermo Fischer, and Tillots. WT reports travel support from IMKASID, ASAN Medical Center, and McMaster University for invited talks. ALH reports consulting fees from AbbVie, Abbivax, AstraZeneca, Bristol Meiers Squibb, Celltrion, Falk, Galapagos, Lilly, Johnson & Johnson, Merck Sharp Dohme, Pfizer, Roche, and Takeda; lecture fees from Abbvie, Bristol Meiers Squibb, Celltrion, Falk, Galapagos, Lilly, Johnson & Johnson, Merck Sharp Dohme, Pfizer, Roche, and Takeda; and meeting travel support from AbbVie, Abbivax, AstraZeneca, Bristol Meiers Squibb, Celltrion, Falk, Galapagos, Lilly, Johnson & Johnson, Merck Sharp Dohme, Pfizer, Roche, Takeda. ANA reports consulting fees from Geneoscopy. NA, S-HL, IP, DT, and PN declare no competing interests.
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