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The document reports distributions by sex, age, race, time since PSC diagnosis, concomitant UDCA and IBD status, partial Mayo and itch NRS scores. It further presents serum liver tests, fibrosis-related markers (ELF score, PRO-C3, transient elastography) and safety outcomes including TEAEs and most frequent adverse events.","| Characteristic | Bexotegrast 40 mg (n=24)c | Bexotegrast 80 mg (n=20)c | Bexotegrast 160 mg (n=20)c | Bexotegrast All (n=64) | Placebo\u003Cbr>(n=21) |\n| --- | --- | --- | --- | --- | --- |\n| Male sex, n (%) | 17 (70 .8) | 16 (80 .0) | 14 (70 .0) | 47 (73 .4) | 17 (81 .0) |\n| Age (yr), mean (SD) | 46.9 (15 .06) | 40.5 (15 .32) | 45.1 (12 .65) | 44.3 (14 .46) | 45.6 (12 .48) |\n| Race, n (%) |  |  |  |  |  |\n| White | 20 (83 .3) | 16 (80 .0) | 18 (90 .0) | 54 (84 .4) | 18 (85 .7) |\n| Black | 2 (8 .3) | 2 (10 .0) | 1 (5 .0) | 5 (7 .8) | 1 (4 .8) |\n| Asian | 2 (8 .3) | 1 (5 .0) | 1 (5 .0) | 4 (6 .3) | 1 (4 .8) |\n| Other / Not Reported / Unknown | 0 | 1 (5 .0) | 0 | 1 (1 .6) | 1 (4 .8) |\n| Time since diagnosis of PSC (yr)a, mean (SD) | 11.1 (8 . 15) | 8.3 (7 .97) | 7.8 (6 .78) | 9.2 (7 .72) | 10.0 (7 .95) |\n| Concomitant UDCA use, n (%) | 14 (58 .3) | 15 (75 .0) | 13 (65 .0) | 42 (65 .6) | 13 (61 .9) |\n| IBD, n (%) | 18 (75 .0) | 12 (60 .0) | 11 (55 .0) | 41 (64 .0) | 12 (57 . 1) |\n| Ulcerative colitis | 11 (45 .8) | 6 (30 .0) | 7 (35 .0) | 24 (37 .5) | 7 (33 .3) |\n| Crohn’s disease | 6 (25 .0) | 4 (20 .0) | 2 (10 .0) | 12 (18 .8) | 4 (19 .0) |\n| IBD other | 3 (12 .5) | 2 (10 .0) | 2 (10 .0) | 7 (10 .9) | 1 (4 .8) |\n| Partial Mayo scoreb, mean (SD) | 0.7 (1 .08) | 1.6 (2 .54) | 1.1 (1 .27) | 1.1 (1 .70) | 0.7 (1 .56) |\n| Itch NRS score, mean (SD) | 1.8 (2 .54) | 2.1 (2 .63) | 1.4 (1 .50) | 1.7 (2 .27) | 1.1 (1 .58) |\n\n|  | Bexotegrast 40 mg (n=24) | Bexotegrast 80 mg (n=20) | Bexotegrast 160 mg (n=20) | Bexotegrast All (n=64) | Placebo\u003Cbr>(n=21) |\n| --- | --- | --- | --- | --- | --- |\n| Serum liver tests, mean (SD) |  |  |  |  |  |\n| Alkaline phosphatasea, U/L | 315.1 (140 .26) | 199.2 (81 .03) | 273.8 (165.63) | 266.0 (140 .68) | 259.7 (185.76) |\n| Alanine aminotransferase, U/L | 91.5 (62.08) | 67.6 (63 . 15) | 98.4 (73 . 11) | 86.2 (66 .25) | 67.5 (49.19) |\n| Aspartate aminotransferase, U/L | 67.2 (49 .34) | 46.4 (30 . 12) | 69.0 (39 .62) | 61.3 (41.70) | 48.8 (30.57) |\n| Total bilirubin, mg/dL | 0.66 (0 .307) | 0.79 (0.493) | 0.88 (0.396) | 0.77 (0.405) | 0.84 (0 .357) |\n| Direct bilirubin, mg/dL | 0.27 (0.164) | 0.26 (0 . 188) | 0.31 (0 . 166) | 0.28 (0.171) | 0.30 (0 . 189) |\n| Markers of fibrosis, mean (SD) |  |  |  |  |  |\n|  |  |  |  |  |  |\n| ELF score | 9.6 (0 .77) | 9.2 (1 .01) | 9.4 (0 .79) | 9.4 (0 .86) | 9.2 (1 .08) |\n| PRO-C3, ng/mL; (Roche COBAS)b | 49.96 (13 .844) | 48.84 (42 .790) | 46.12 (11 .670) | 48.39 (25.904) | 43.24 (10 .828) |\n| Transient elastography, kPa | 10.1 (2 .62) | 9.1 (2 .99) | 8.2 (3 . 16) | 9.2 (2 .98) | 8.5 (2.86) |\n\n| TEAE, n (%) of participants reporting | Bexotegrast 40 mg (n=24) | Bexotegrast 80 mg (n=20) | Bexotegrast 160 mg (n=20) | Bexotegrast All (n=64) | Placebo\u003Cbr>(n=21) |\n| --- | --- | --- | --- | --- | --- |\n| TEAE | 10 (41 .7) | 16 (80 .0) | 15 (75 .0) | 41 (64 . 1) | 16 (76 .2) |\n| Related to study drug | 1 (4 .2) | 6 (30 .0) | 4 (20 .0) | 11 (17 .2) | 7 (33.3) |\n| Serious TEAE | 1 (4 .2) | 1 (5 .0) | 0 | 2 (3 . 1) | 0 |\n| Related to study drug | 0 | 0 | 0 | 0 | 0 |\n| Most frequent TEAEs (n ≥ 3 in at least one arm) |  |  |  |  |  |\n| Pruritusa | 2 (8 .3) | 4 (20 .0) | 3 (15.0) | 9 (14.1) | 5 (23.8) |\n| Fatigue | 3 (12.5) | 2 (10 .0) | 4 (20 .0) | 9 (14.1) | 2 (9 .5) |\n| Headache | 1 (4 .2) | 2 (10 .0) | 3 (15.0) | 6 (9 .4) | 4 (19 .0) |\n| Nausea | 1 (4 .2) | 2 (10 .0) | 3 (15.0) | 6 (9 .4) | 0 |\n| COVID-19 | 2 (8 .3) | 1 (5 .0) | 0 | 3 (4.7) | 3 (14.3) |\n| Frequent bowel movements | 0 | 3 (15.0) | 0 | 3 (4.7) | 3 (14.3) |\n| Cholangitis | 0 | 1 (5 .0) | 1 (5 .0) | 2 (3 . 1) | 3 (14.3) |","cbCailh45EYOoDhs","https://ap.wps.com/l/cbCailh45EYOoDhs","pdf",1236607,18,"English","en",105,"# Participant characteristics\n## Serum liver tests\n## Markers of fibrosis\n## Safety and TEAEs\n## Most frequent TEAEs","[{\"question\":\"What participant baseline characteristics are reported across treatment groups?\",\"answer\":\"Sex, age, race, time since diagnosis of PSC, concomitant UDCA use, and IBD breakdown are reported, along with partial Mayo score and itch NRS score.\"},{\"question\":\"Which serum liver tests and fibrosis markers are included in the efficacy data?\",\"answer\":\"Serum liver tests include alkaline phosphatase, ALT, AST, total bilirubin and direct bilirubin. Fibrosis markers include ELF score, PRO-C3, and transient elastography (kPa).\"},{\"question\":\"How is safety assessed and what are the most frequent TEAEs?\",\"answer\":\"Safety is summarized using TEAEs by incidence, including serious TEAEs and relatedness to study drug. The most frequent TEAEs include pruritus, fatigue, headache, nausea, COVID-19, frequent bowel movements, and cholangitis.\"}]","Pliant-AASLD-2023-INTEGRIS-PSC-LB-Presentation_FINAL | PDF",1788385842,6,{"code":4,"msg":31,"data":32},"ok",{"site_id":24,"language":23,"slug":33,"title":14,"keywords":34,"description":15,"schema_data":35,"social_meta":87,"head_meta":89,"extra_data":91,"updated_unix":28},"pliant-aasld-2023-integris-psc-lb-presentation_final","",{"@graph":36,"@context":86},[37,54,69],{"@type":38,"itemListElement":39},"BreadcrumbList",[40,44,48,51],{"item":41,"name":42,"@type":43,"position":11},"https://docshare.wps.com","Home","ListItem",{"item":45,"name":46,"@type":43,"position":47},"https://docshare.wps.com/template/","Template",2,{"item":49,"name":13,"@type":43,"position":50},"https://docshare.wps.com/template/presentations/",3,{"item":52,"name":14,"@type":43,"position":53},"https://docshare.wps.com/template/pliant-aasld-2023-integris-psc-lb-presentation_final/187867/",4,{"url":52,"name":14,"@type":55,"author":56,"headline":14,"publisher":58,"fileFormat":61,"inLanguage":23,"description":15,"dateModified":62,"datePublished":63,"encodingFormat":61,"isAccessibleForFree":64,"interactionStatistic":65},"DigitalDocument",{"name":9,"@type":57},"Person",{"url":41,"name":59,"@type":60},"DocShare","Organization","application/pdf","2026-09-05","2026-09-02",true,{"@type":66,"interactionType":67,"userInteractionCount":11},"InteractionCounter",{"@type":68},"ViewAction",{"@type":70,"mainEntity":71},"FAQPage",[72,78,82],{"name":73,"@type":74,"acceptedAnswer":75},"What participant baseline characteristics are reported across treatment groups?","Question",{"text":76,"@type":77},"Sex, age, race, time since diagnosis of PSC, concomitant UDCA use, and IBD breakdown are reported, along with partial Mayo score and itch NRS score.","Answer",{"name":79,"@type":74,"acceptedAnswer":80},"Which serum liver tests and fibrosis markers are included in the efficacy data?",{"text":81,"@type":77},"Serum liver tests include alkaline phosphatase, ALT, AST, total bilirubin and direct bilirubin. Fibrosis markers include ELF score, PRO-C3, and transient elastography (kPa).",{"name":83,"@type":74,"acceptedAnswer":84},"How is safety assessed and what are the most frequent TEAEs?",{"text":85,"@type":77},"Safety is summarized using TEAEs by incidence, including serious TEAEs and relatedness to study drug. The most frequent TEAEs include pruritus, fatigue, headache, nausea, COVID-19, frequent bowel movements, and cholangitis.","https://schema.org",{"og:url":52,"og:type":88,"og:title":14,"og:site_name":59,"og:description":15},"article",{"robots":90,"canonical":52},"index,follow",{"doc_id":7,"site_id":24},{"code":4,"msg":5,"data":93},[94,97,102,107,112,117,122,126,131],{"id":12,"doc_module":11,"doc_module_name":46,"category_name":13,"show_sort_weight":95,"slug":96},90,"presentations",{"id":98,"doc_module":11,"doc_module_name":46,"category_name":99,"show_sort_weight":100,"slug":101},12,"Resumes",80,"resumes",{"id":103,"doc_module":11,"doc_module_name":46,"category_name":104,"show_sort_weight":105,"slug":106},14,"Invoices",70,"invoices",{"id":108,"doc_module":11,"doc_module_name":46,"category_name":109,"show_sort_weight":110,"slug":111},15,"Posters",60,"posters",{"id":113,"doc_module":11,"doc_module_name":46,"category_name":114,"show_sort_weight":115,"slug":116},16,"Social Media",50,"social-media",{"id":118,"doc_module":11,"doc_module_name":46,"category_name":119,"show_sort_weight":120,"slug":121},17,"Forms",40,"forms",{"id":21,"doc_module":11,"doc_module_name":46,"category_name":123,"show_sort_weight":124,"slug":125},"Letters",30,"letters",{"id":127,"doc_module":11,"doc_module_name":46,"category_name":128,"show_sort_weight":129,"slug":130},21,"Paper Templates",5,"papers-templates",{"id":132,"doc_module":11,"doc_module_name":46,"category_name":133,"show_sort_weight":4,"slug":134},158,"General","general-158"]