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Preclinical studies indicate that blocking IL\u201023\/IL\u201017 signalling may reverse liver injury. Guselkumab, an IL\u201023\u2010specific antibody approved for psoriasis, may be beneficial for ALD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p>We aimed to assess the safety and tolerability of guselkumab in patients with ALD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This phase\u20101 dose\u2010escalation study included patients with \u2265\u20092 DSM\u20105 criteria for alcohol use disorder, significant steatosis (MRI\u2010PDFF \u2265\u20098%) and MRE &lt;\u20093.63\u2009kPa (to exclude advanced disease). Guselkumab was given subcutaneously on Days 1 and 29 in 30, 70 or 100\u2009mg dose cohorts. Primary endpoints were adverse events (AEs) and dose\u2010limiting toxicity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We enrolled 13 patients (three 30\u2009mg, three 70\u2009mg, and seven 100\u2009mg). Eleven completed the study and two early discontinued in the 100\u2009mg group. Of them, 77% were men, and the median age was 53 [IQR 49\u201361] years. The median MRI\u2010PDFF and MRE were 18.4% [IQR 8.4%\u201334.0%] and 2.5 [2.2\u20132.6] kPa, respectively. The most frequent AEs were hyperuricemia (13%, mild only) and elevated lipase (11%, mild and moderate). There were no serious adverse events or significant variations in liver enzymes. There was a suppression of peripheral interleukin (IL)\u201017, IL\u201023, IL\u20101b and TNF\u2010\u03b1 in the 70 and 100\u2009mg groups, and a significant decrease in alcohol consumption over time (AUDIT\u2010C: 6 [3\u20137] vs. 5 [1\u20136], <jats:italic>p<\/jats:italic>\u2009=\u20090.023).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Guselkumab is safe in doses up to 100\u2009mg and may reduce inflammation markers in ALD. These findings support further phase 2 studies to evaluate the efficacy of guselkumab in ALD, particularly in patients with severe phenotypes.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.70026","type":"journal-article","created":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T03:08:36Z","timestamp":1739502516000},"page":"1140-1151","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Clinical Trial to Assess the Safety and Tolerability of Anti\u2010<scp>IL<\/scp> 23 Monoclonal Antibody Guselkumab in Patients With Alcohol\u2010Associated Liver Disease"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8540-4930","authenticated-orcid":false,"given":"Luis Antonio","family":"Diaz","sequence":"first","affiliation":[{"name":"MASLD Research Center, Division of Gastroenterology and Hepatology University of California San Diego  San Diego California USA"},{"name":"Departamento de 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