Design of Clinical Trials for Mild to Moderate Ulcerative Colitis

TY - JOUR

T1 - Design of Clinical Trials for Mild to Moderate Ulcerative Colitis

AU - Sedano, Rocio

AU - Jairath, Vipul

AU - IBD Trial Design Group

AU - Ma, Christopher

AU - Hanzel, Jurji

AU - Shackelton, Lisa M.

AU - McFarlane, Stefanie

AU - D'Haens, Geert R.

AU - Sandborn, William J.

AU - Feagan, Brian G.

N1 - Funding Information: The IBD Trial Design Group includes Rocio Sedano,1,2 Jurji Hanzel,2,3,4 Lisa M. Shackelton,2 Stefanie McFarlane,2 Geert R. D'Haens,2,5 William J. Sandborn,2,6 Brian G. Feagan,1,2,7 Vipul Jairath,1,2,7, and Christopher Ma2,8; from the 1Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; 2Alimentiv Inc, London, Ontario, Canada; 3Department of Gastroenterology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia; 4Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, Academic Medical Centre, Amsterdam, the Netherlands; 5Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam Gastroenterology and Metabolism Research Institute, University of Amsterdam, Amsterdam, the Netherlands; 6Division of Gastroenterology, University of California San Diego, La Jolla, California; 7Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada; and 8Division of Gastroenterology and Hepatology, Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, Alberta, Canada. Conflicts of interest Alimentiv Inc (formerly Robarts Clinical Trials, Inc) is an academic gastrointestinal contract research organization, operating under the Alimentiv Health Trust. The beneficiaries of this trust are the employees of the enterprises it holds. None of the academic authors are beneficiaries of the Alimentiv Health Trust. Alimentiv Inc provides centralized imaging management solutions in clinical trials, including endoscopy, histopathology, and magnetic resonance imaging. Alimentiv Inc provides full-service clinical research organization capabilities as well as precision medicine services. Rocio Sedano, Jurji Hanzel, Lisa M. Shackelton, Geert R. D'Haens, William J. Sandborn, Brian G. Feagan, Vipul Jairath, and Christopher Ma are consultants to Alimentiv but have neither equity positions nor shares in Alimentiv Inc. Jurji Hanzel, Geert R. D'Haens, William J. Sandborn, Brian G. Feagan, Vipul Jairath, Christopher Ma have primary university academic appointments. This manuscript has undergone independent, external, blinded peer review by reviewers without Alimentiv Inc affiliations. Rocio Sedano has received consulting fees from Alimentiv Inc. Jurji Hanzel has received speaker fees from AbbVie, Janssen, and Takeda and consulting fees from Alimentiv Inc. Lisa M. Shackelton has received consulting fees from Alimentiv Inc. Stefanie McFarlane is an employee of Alimentiv Inc. Geert R. D'Haens has served as an advisor for AbbVie, Ablynx, Alimentiv Inc, Allergan, Amakem, Amgen, AM Pharma, Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene/Receptos, Celltrion, Cosmo, Covidien/Medtronic, Ferring, Dr Falk Pharma, Eli Lilly, enGene, Galapagos, Genentech/Roche, Gilead, GlaxoSmithKline, Hospira/Pfizer, Immunic, Johnson & Johnson, Lycera, Medimetrics, Millennium/Takeda, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novo Nordisk, Otsuka, Pfizer/Hospira, PhotoPill, Prometheus Laboratories/Nestle, Progenity, Protagonist, Salix, Samsung Bioepis, Sandoz, Seres/Nestlé, Setpoint, Shire, Teva, TiGenix, Tillotts, TopiVert, Versant, and Vifor and has received speaker fees from AbbVie, Biogen, Ferring, Johnson & Johnson, Merck Sharp Dome, Mundipharma, Norgine, Pfizer, Samsung Bioepis, Shire, Millennium/Takeda, Tillotts, and Vifor. William J. Sandborn has received research grants from AbbVie, Abivax, Arena Pharmaceuticals, Boehringer Ingelheim, Celgene, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Lilly, Pfizer, Prometheus Biosciences, Seres Therapeutics, Shire, Takeda, Theravance Biopharma; has received consulting fees from AbbVie, Abivax, AdMIRx, Alfasigma, Alimentiv (previously Robarts Clinical Trials, owned by Alimentiv Health Trust), Alivio Therapeutics, Allakos, Amgen, Applied Molecular Transport, Arena Pharmaceuticals, Bausch Health (Salix), BeiGene, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Meyers Squibb, Celgene, Celltrion, Cellularity, Cosmo Pharmaceuticals, Escalier Biosciences, Equillium, Forbion, Genentech/Roche, Gilead Sciences, Glenmark Pharmaceuticals, Gossamer Bio, Immunic (Vital Therapies), Index Pharmaceuticals, Intact Therapeutics, Janssen, Kyverna Therapeutics, Landos Biopharma, Lilly, Oppilan Pharma, Otsuka, Pandion Therapeutics, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonists Therapeutics, ProventionBio, Reistone Biopharma, Seres Therapeutics, Shanghai Pharma Biotherapeutics, Shire, Shoreline Biosciences, Sublimity Therapeutics, Surrozen, Takeda, Theravance Biopharma, Thetis Pharmaceuticals, Tillotts Pharma, UCB, Vedanta Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivelix Pharmaceuticals, Vivreon Biosciences, and Zealand Pharma; has received stock or stock options from Allakos, BeiGene, Gossamer Bio, Oppilan Pharma, Prometheus Biosciences, Prometheus Laboratories Progenity, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences, and Vivreon Biosciences; and is an employee at Shoreline Biosciences; in addition, his spouse reports the following: Iveric Bio: consultant, stock options; Progenity: stock; Oppilan Pharma: consultant, stock options; Prometheus Biosciences: employee, stock, stock options; Prometheus Laboratories: stock, stock options, consultant; Ventyx Biosciences: stock, stock options; and Vimalan Biosciences: stock, stock options. Brian G. Feagan is a scientific advisory board member for AbbVie, Allergan, Amgen, AstraZeneca, Avaxia Biologics Inc, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Elan, Biogen, Ferring, Genentech-Roche, Janssen–Johnson & Johnson, Merck, Millennium, Nestlé, Novo Nordisk, Novartis, Pfizer, Prometheus, Protagonist, Receptos, Salix, Sigmoid Pharma, Takeda, Teva, TiGenix, Tillotts Pharma, and UCB Pharma; has received consulting fees from AbbVie, ActoGeniX, Akros, Albireo Pharma, Allergan, Amgen, AstraZeneca, Avaxia Biologics, Avir Pharma, Axcan, Baxter Healthcare, Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan–Biogen, EnGene, Ferring, Genentech–Roche, GiCare Pharma, Gilead Sciences, Given Imaging, GlaxoSmithKline, Ironwood, Janssen Biotech–Centocor, Janssen–Johnson & Johnson, Kyowa Hakko Kirin, Eli Lilly, Merck, Mesoblast Pharma, Millennium, Nestlé, Novo Nordisk, Novartis, Pfizer, Prometheus, Protagonist, Receptos Salix, Sanofi, Shire, Sigmoid Pharma, Synergy Pharma, Takeda, Teva, TiGenix, Tillotts Pharma, UCB Pharma, Vertex, VHsquared, Wyeth, Zealand, and Zyngenia; has received lecture fees from AbbVie, Janssen–Johnson & Johnson, Takeda, and UCB Pharma; has received grant support from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Janssen Biotech–Centocor, Janssen–Johnson & Johnson, Pfizer, Receptos, Sanofi, and Takeda; and is the senior scientific officer of Alimentiv Inc. Vipul Jairath has received consulting fees from AbbVie, Alimentiv Inc (formerly Robarts Clinical Trials), Arena Pharmaceuticals, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, GlaxoSmithKline, Genetech, Gilead, Janssen, Merck, Mylan, Pendopharm, Pfizer, Roche, Sandoz, Takeda, and TopiVert and speaker fees from AbbVie, Ferring, Janssen Pfizer, Shire, and Takeda. Christopher Ma has received consulting fees from AbbVie, Amgen, AVIR Pharma Inc, Bristol Myers Squibb, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Takeda, Pfizer, Roche, Alimentiv (formerly Robarts Clinical Trials Inc); speaker fees from AbbVie, AVIR Pharma Inc, Janssen, Takeda, and Pfizer; and research support from Pfizer. Funding Information: Rocio Sedano has received consulting fees from Alimentiv Inc. Jurji Hanzel has received speaker fees from AbbVie, Janssen, and Takeda and consulting fees from Alimentiv Inc. Lisa M. Shackelton has received consulting fees from Alimentiv Inc. Stefanie McFarlane is an employee of Alimentiv Inc. Geert R. D’Haens has served as an advisor for AbbVie, Ablynx, Alimentiv Inc, Allergan, Amakem, Amgen, AM Pharma, Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene/Receptos, Celltrion, Cosmo, Covidien/Medtronic, Ferring, Dr Falk Pharma, Eli Lilly, enGene, Galapagos, Genentech/Roche, Gilead, GlaxoSmithKline, Hospira/Pfizer, Immunic, Johnson & Johnson, Lycera, Medimetrics, Millennium/Takeda, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novo Nordisk, Otsuka, Pfizer/Hospira, PhotoPill, Prometheus Laboratories/Nestle, Progenity, Protagonist, Salix, Samsung Bioepis, Sandoz, Seres/Nestlé, Setpoint, Shire, Teva, TiGenix, Tillotts, TopiVert, Versant, and Vifor and has received speaker fees from AbbVie, Biogen, Ferring, Johnson & Johnson, Merck Sharp Dome, Mundipharma, Norgine, Pfizer, Samsung Bioepis, Shire, Millennium/Takeda, Tillotts, and Vifor. William J. Sandborn has received research grants from AbbVie, Abivax, Arena Pharmaceuticals, Boehringer Ingelheim, Celgene, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Lilly, Pfizer, Prometheus Biosciences, Seres Therapeutics, Shire, Takeda, Theravance Biopharma; has received consulting fees from AbbVie, Abivax, AdMIRx, Alfasigma, Alimentiv (previously Robarts Clinical Trials, owned by Alimentiv Health Trust), Alivio Therapeutics, Allakos, Amgen, Applied Molecular Transport, Arena Pharmaceuticals, Bausch Health (Salix), BeiGene, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Meyers Squibb, Celgene, Celltrion, Cellularity, Cosmo Pharmaceuticals, Escalier Biosciences, Equillium, Forbion, Genentech/Roche, Gilead Sciences, Glenmark Pharmaceuticals, Gossamer Bio, Immunic (Vital Therapies), Index Pharmaceuticals, Intact Therapeutics, Janssen, Kyverna Therapeutics, Landos Biopharma, Lilly, Oppilan Pharma, Otsuka, Pandion Therapeutics, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonists Therapeutics, ProventionBio, Reistone Biopharma, Seres Therapeutics, Shanghai Pharma Biotherapeutics, Shire, Shoreline Biosciences, Sublimity Therapeutics, Surrozen, Takeda, Theravance Biopharma, Thetis Pharmaceuticals, Tillotts Pharma, UCB, Vedanta Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivelix Pharmaceuticals, Vivreon Biosciences, and Zealand Pharma; has received stock or stock options from Allakos, BeiGene, Gossamer Bio, Oppilan Pharma, Prometheus Biosciences, Prometheus Laboratories Progenity, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences, and Vivreon Biosciences; and is an employee at Shoreline Biosciences; in addition, his spouse reports the following: Iveric Bio: consultant, stock options; Progenity: stock; Oppilan Pharma: consultant, stock options; Prometheus Biosciences: employee, stock, stock options; Prometheus Laboratories: stock, stock options, consultant; Ventyx Biosciences: stock, stock options; and Vimalan Biosciences: stock, stock options. Brian G. Feagan is a scientific advisory board member for AbbVie, Allergan, Amgen, AstraZeneca, Avaxia Biologics Inc, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Elan, Biogen, Ferring, Genentech-Roche, Janssen–Johnson & Johnson, Merck, Millennium, Nestlé, Novo Nordisk, Novartis, Pfizer, Prometheus, Protagonist, Receptos, Salix, Sigmoid Pharma, Takeda, Teva, TiGenix, Tillotts Pharma, and UCB Pharma; has received consulting fees from AbbVie, ActoGeniX, Akros, Albireo Pharma, Allergan, Amgen, AstraZeneca, Avaxia Biologics, Avir Pharma, Axcan, Baxter Healthcare, Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan–Biogen, EnGene, Ferring, Genentech–Roche, GiCare Pharma, Gilead Sciences, Given Imaging, GlaxoSmithKline, Ironwood, Janssen Biotech–Centocor, Janssen–Johnson & Johnson, Kyowa Hakko Kirin, Eli Lilly, Merck, Mesoblast Pharma, Millennium, Nestlé, Novo Nordisk, Novartis, Pfizer, Prometheus, Protagonist, Receptos Salix, Sanofi, Shire, Sigmoid Pharma, Synergy Pharma, Takeda, Teva, TiGenix, Tillotts Pharma, UCB Pharma, Vertex, VHsquared, Wyeth, Zealand, and Zyngenia; has received lecture fees from AbbVie, Janssen–Johnson & Johnson, Takeda, and UCB Pharma; has received grant support from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Janssen Biotech–Centocor, Janssen–Johnson & Johnson, Pfizer, Receptos, Sanofi, and Takeda; and is the senior scientific officer of Alimentiv Inc. Vipul Jairath has received consulting fees from AbbVie, Alimentiv Inc (formerly Robarts Clinical Trials), Arena Pharmaceuticals, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, GlaxoSmithKline, Genetech, Gilead, Janssen, Merck, Mylan, Pendopharm, Pfizer, Roche, Sandoz, Takeda, and TopiVert and speaker fees from AbbVie, Ferring, Janssen Pfizer, Shire, and Takeda. Christopher Ma has received consulting fees from AbbVie, Amgen, AVIR Pharma Inc, Bristol Myers Squibb, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Takeda, Pfizer, Roche, Alimentiv (formerly Robarts Clinical Trials Inc); speaker fees from AbbVie, AVIR Pharma Inc, Janssen, Takeda, and Pfizer; and research support from Pfizer.

PY - 2022/4/1

Y1 - 2022/4/1

UR - http://www.scopus.com/inward/record.url?scp=85126269021&partnerID=8YFLogxK

U2 - https://doi.org/10.1053/j.gastro.2021.12.284

DO - https://doi.org/10.1053/j.gastro.2021.12.284

M3 - Article

C2 - 34998800

SN - 0016-5085

VL - 162

SP - 1005

EP - 1018

JO - Gastroenterology

JF - Gastroenterology

IS - 4

ER -