Pub Date : 2025-11-17DOI: 10.1016/s2468-1253(25)00299-7
Nanne K de Boer, Richard B Gearry, Charles N Bernstein, Rupa Banerjee, David T Rubin, Gilaad G Kaplan
No Abstract
没有抽象的
{"title":"The essential medicines list for inflammatory bowel disease: time to raise the standards of global care","authors":"Nanne K de Boer, Richard B Gearry, Charles N Bernstein, Rupa Banerjee, David T Rubin, Gilaad G Kaplan","doi":"10.1016/s2468-1253(25)00299-7","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00299-7","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"41 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145536429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-13DOI: 10.1016/s2468-1253(25)00296-1
Vipul Jairath, Silvio Danese, Geert R D’Haens, Brian G Feagan, Laurent Peyrin-Biroulet, Bruce E Sands, Ingrid Gaemers, Matt Westfall, Allyson Q Terry, Kevin J Roberts, Sara Barbat, Pamela Wedel, Jacqueline M Benson, Carlos Sattler
<h3>Background</h3>SOR102 is an oral bispecific antibody comprised of single domain antibodies targeting TNF and interleukin (IL)-23p19. We aimed to assess the safety, pharmacokinetics, clinical, and biological activity of SOR102 in healthy participants and in patients with active ulcerative colitis.<h3>Methods</h3>This phase 1 first-in-human, double-blind, randomised, placebo-controlled, trial was done in the UK, Ukraine, and Georgia in clinical research centres. Central randomisation was by an interactive web response system and a randomisation scheme produced by an unmasked, independent statistician. In part 1, healthy participants were randomly assigned (6:2) to single ascending doses of SOR102 or placebo. In part 2, healthy participants were randomly assigned (8:2) to SOR102 or placebo twice daily for 7 days. In part 3, patients with mildly-to-severely active ulcerative colitis were randomly assigned (1:1:1) to once-daily or twice-daily SOR102 or placebo for 42 days. The primary objective was to evaluate the safety and tolerability of SOR102. Safety analyses were done on all participants or patients who received at least one dose of study drug. This trial is registered with <span><span>ClinicalTrials.gov</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>, <span><span>NCT06080048</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span> and is complete.<h3>Findings</h3>From Oct 9, 2023, to Oct 16, 2024, 157 participants were assessed for eligibility, of whom 93 were excluded and 64 were randomly assigned to either SOR102 (n=48) or placebo (n=16) across all three parts of the study. In part 1, six participants were randomly assigned to receive SOR102 135 mg, six to receive SOR102 405 mg, six to receive SOR102 1215 mg, six to receive SOR102 3645 mg, and eight to receive placebo. In part 2, eight participants were randomly assigned to receive SOR102 1215 mg twice-daily and two to receive placebo. In part 3, seven patients with ulcerative colitis were randomly assigned to receive SOR102 810 mg once-daily, nine to receive the same dose twice-daily, and six to receive placebo. In part 1, treatment-emergent adverse events (TEAEs) occurred in three (13%) of 24 participants who received SOR102 (two in the SOR102 135 mg dose group and one in the SOR102 405 mg dose group; mild diarrhoea and moderate dysmenorrhoea both in a single participant in the SOR102 135 mg group and mild flatulence in a second participant in same group; mild dysmenorrhoea in one participant in the SOR102 405 mg group) compared with two (25%) of eight participants who received placebo (mild catheter site pain; mild headache). Only the TEAE of mild diarrhoea was deemed trea
{"title":"Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial","authors":"Vipul Jairath, Silvio Danese, Geert R D’Haens, Brian G Feagan, Laurent Peyrin-Biroulet, Bruce E Sands, Ingrid Gaemers, Matt Westfall, Allyson Q Terry, Kevin J Roberts, Sara Barbat, Pamela Wedel, Jacqueline M Benson, Carlos Sattler","doi":"10.1016/s2468-1253(25)00296-1","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00296-1","url":null,"abstract":"<h3>Background</h3>SOR102 is an oral bispecific antibody comprised of single domain antibodies targeting TNF and interleukin (IL)-23p19. We aimed to assess the safety, pharmacokinetics, clinical, and biological activity of SOR102 in healthy participants and in patients with active ulcerative colitis.<h3>Methods</h3>This phase 1 first-in-human, double-blind, randomised, placebo-controlled, trial was done in the UK, Ukraine, and Georgia in clinical research centres. Central randomisation was by an interactive web response system and a randomisation scheme produced by an unmasked, independent statistician. In part 1, healthy participants were randomly assigned (6:2) to single ascending doses of SOR102 or placebo. In part 2, healthy participants were randomly assigned (8:2) to SOR102 or placebo twice daily for 7 days. In part 3, patients with mildly-to-severely active ulcerative colitis were randomly assigned (1:1:1) to once-daily or twice-daily SOR102 or placebo for 42 days. The primary objective was to evaluate the safety and tolerability of SOR102. Safety analyses were done on all participants or patients who received at least one dose of study drug. This trial is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, <span><span>NCT06080048</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> and is complete.<h3>Findings</h3>From Oct 9, 2023, to Oct 16, 2024, 157 participants were assessed for eligibility, of whom 93 were excluded and 64 were randomly assigned to either SOR102 (n=48) or placebo (n=16) across all three parts of the study. In part 1, six participants were randomly assigned to receive SOR102 135 mg, six to receive SOR102 405 mg, six to receive SOR102 1215 mg, six to receive SOR102 3645 mg, and eight to receive placebo. In part 2, eight participants were randomly assigned to receive SOR102 1215 mg twice-daily and two to receive placebo. In part 3, seven patients with ulcerative colitis were randomly assigned to receive SOR102 810 mg once-daily, nine to receive the same dose twice-daily, and six to receive placebo. In part 1, treatment-emergent adverse events (TEAEs) occurred in three (13%) of 24 participants who received SOR102 (two in the SOR102 135 mg dose group and one in the SOR102 405 mg dose group; mild diarrhoea and moderate dysmenorrhoea both in a single participant in the SOR102 135 mg group and mild flatulence in a second participant in same group; mild dysmenorrhoea in one participant in the SOR102 405 mg group) compared with two (25%) of eight participants who received placebo (mild catheter site pain; mild headache). Only the TEAE of mild diarrhoea was deemed trea","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"25 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145509303","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-13DOI: 10.1016/s2468-1253(25)00330-9
Raja Atreya, Markus F Neurath
No Abstract
没有抽象的
{"title":"Dual targeting of TNF and IL-23 by a bispecific antibody in ulcerative colitis","authors":"Raja Atreya, Markus F Neurath","doi":"10.1016/s2468-1253(25)00330-9","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00330-9","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"373 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145509667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-06DOI: 10.1016/s2468-1253(25)00288-2
Davy van de Sande, Stefan Sleijfer, Stefan N R Buijsman, Diederik Gommers, Michel E van Genderen
{"title":"Endoscopist deskilling risk after exposure to artificial intelligence in colonoscopy","authors":"Davy van de Sande, Stefan Sleijfer, Stefan N R Buijsman, Diederik Gommers, Michel E van Genderen","doi":"10.1016/s2468-1253(25)00288-2","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00288-2","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"50 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145447456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-06DOI: 10.1016/s2468-1253(25)00289-4
Asaf Levartovsky, Uri Kopylov
{"title":"Endoscopist deskilling risk after exposure to artificial intelligence in colonoscopy","authors":"Asaf Levartovsky, Uri Kopylov","doi":"10.1016/s2468-1253(25)00289-4","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00289-4","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"62 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145447455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-05DOI: 10.1016/s2468-1253(25)00326-7
No Abstract
没有抽象的
{"title":"Bridging the evidence gap in dietary approaches to gut disorders","authors":"","doi":"10.1016/s2468-1253(25)00326-7","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00326-7","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"135 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145448180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-28DOI: 10.1016/s2468-1253(25)00192-x
Gideon M Hirschfield, Christopher L Bowlus, David E J Jones, Andreas E Kremer, Marlyn J Mayo, Atsushi Tanaka, Pietro Andreone, Jidong Jia, Qinglong Jin, Ricardo U Macías-Rodríguez, Alexander R Cobitz, Brooke M Currie, Ciara Gorey, Ivana Lazic, Danielle Podmore, Andrea Ribeiro, Jennifer B Shannon, Brandon Swift, Megan M McLaughlin, Cynthia Levy
{"title":"Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial","authors":"Gideon M Hirschfield, Christopher L Bowlus, David E J Jones, Andreas E Kremer, Marlyn J Mayo, Atsushi Tanaka, Pietro Andreone, Jidong Jia, Qinglong Jin, Ricardo U Macías-Rodríguez, Alexander R Cobitz, Brooke M Currie, Ciara Gorey, Ivana Lazic, Danielle Podmore, Andrea Ribeiro, Jennifer B Shannon, Brandon Swift, Megan M McLaughlin, Cynthia Levy","doi":"10.1016/s2468-1253(25)00192-x","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00192-x","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"1 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145382777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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