{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T12:51:28Z","timestamp":1788871888466,"version":"build-2803163510"},"reference-count":47,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2024,12,1]],"date-time":"2024-12-01T00:00:00Z","timestamp":1733011200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2024,12,1]],"date-time":"2024-12-01T00:00:00Z","timestamp":1733011200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2024,10,25]],"date-time":"2024-10-25T00:00:00Z","timestamp":1729814400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002491","name":"Bristol-Myers Squibb","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002491","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.fr","clinicalkey.jp","clinicalkey.es","clinicalkey.com.au","clinicalkey.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Contemporary Clinical Trials"],"published-print":{"date-parts":[[2024,12]]},"DOI":"10.1016\/j.cct.2024.107708","type":"journal-article","created":{"date-parts":[[2024,10,9]],"date-time":"2024-10-09T17:27:04Z","timestamp":1728494824000},"page":"107708","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":7,"special_numbering":"C","title":["Design of a phase 3, randomized, double-blind, placebo-controlled, 48-week study to evaluate the efficacy and safety of cendakimab in adult and adolescent patients with eosinophilic esophagitis"],"prefix":"10.1016","volume":"147","author":[{"given":"Christina M.","family":"Charriez","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia H.M.C.","family":"de Oliveira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vrunda","family":"Patel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Young S.","family":"Oh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ikuo","family":"Hirano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Schoepfer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evan S.","family":"Dellon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"3","key":"10.1016\/j.cct.2024.107708_bb0005","doi-asserted-by":"crossref","first-page":"249","DOI":"10.1007\/s00535-019-01624-3","article-title":"Clinical relevance of esophageal subepithelial activity in eosinophilic esophagitis","volume":"55","author":"Hirano","year":"2020","journal-title":"J. Gastroenterol."},{"issue":"17","key":"10.1016\/j.cct.2024.107708_bb0010","doi-asserted-by":"crossref","first-page":"1640","DOI":"10.1056\/NEJMra1502863","article-title":"Eosinophilic esophagitis","volume":"373","author":"Furuta","year":"2015","journal-title":"N. Engl. J. Med."},{"issue":"2","key":"10.1016\/j.cct.2024.107708_bb0015","doi-asserted-by":"crossref","first-page":"333","DOI":"10.1053\/j.gastro.2017.06.065","article-title":"Pathophysiology of eosinophilic esophagitis","volume":"154","author":"O'Shea","year":"2018","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cct.2024.107708_bb0020","doi-asserted-by":"crossref","first-page":"S79","DOI":"10.1016\/j.anai.2022.08.981","article-title":"Prevalence and characteristics of eosinophilic esophagitis in 2019","volume":"129","author":"Miluski","year":"2022","journal-title":"Ann. Allergy Asthma Immunol."},{"issue":"9","key":"10.1016\/j.cct.2024.107708_bb0025","doi-asserted-by":"crossref","first-page":"1116","DOI":"10.1111\/apt.15231","article-title":"Systematic review with meta-analysis: the growing incidence and prevalence of eosinophilic oesophagitis in children and adults in population-based studies","volume":"49","author":"Navarro","year":"2019","journal-title":"Aliment. Pharmacol. Ther."},{"issue":"12","key":"10.1016\/j.cct.2024.107708_bb0030","doi-asserted-by":"crossref","first-page":"697","DOI":"10.1038\/nrgastro.2012.182","article-title":"Therapeutic concepts in adult and paediatric eosinophilic oesophagitis","volume":"9","author":"Straumann","year":"2012","journal-title":"Nat. Rev. Gastroenterol. Hepatol."},{"issue":"2","key":"10.1016\/j.cct.2024.107708_bb0035","first-page":"97","article-title":"Dysphagia: evaluation and collaborative management","volume":"103","author":"Wilkinson","year":"2021","journal-title":"Am. Fam. Physician"},{"issue":"2","key":"10.1016\/j.cct.2024.107708_bb0040","doi-asserted-by":"crossref","first-page":"319","DOI":"10.1053\/j.gastro.2017.06.067","article-title":"Epidemiology and natural history of eosinophilic esophagitis","volume":"154","author":"Dellon","year":"2018","journal-title":"Gastroenterology"},{"issue":"5","key":"10.1016\/j.cct.2024.107708_bb0045","doi-asserted-by":"crossref","first-page":"1316","DOI":"10.1053\/j.gastro.2008.02.016","article-title":"Eosinophilic esophagitis: a prevalent disease in the United States that affects all age groups","volume":"134","author":"Kapel","year":"2008","journal-title":"Gastroenterology"},{"issue":"2","key":"10.1016\/j.cct.2024.107708_bb0050","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1097\/00042737-200602000-00015","article-title":"Eosinophilic esophagitis in adults: a systematic review","volume":"18","author":"Sgouros","year":"2006","journal-title":"Eur. J. Gastroenterol. Hepatol."},{"issue":"3","key":"10.1016\/j.cct.2024.107708_bb0055","doi-asserted-by":"crossref","first-page":"313","DOI":"10.1016\/j.gie.2006.04.037","article-title":"Histopathologic variability and endoscopic correlates in adults with eosinophilic esophagitis","volume":"64","author":"Gonsalves","year":"2006","journal-title":"Gastrointest. Endosc."},{"issue":"8","key":"10.1016\/j.cct.2024.107708_bb0060","doi-asserted-by":"crossref","first-page":"479","DOI":"10.1038\/nrgastro.2017.56","article-title":"Management of refractory eosinophilic oesophagitis","volume":"14","author":"Dellon","year":"2017","journal-title":"Nat. Rev. Gastroenterol. Hepatol."},{"key":"10.1016\/j.cct.2024.107708_bb0065","series-title":"Real-Life Effectiveness of Swallowed Topical Steroids, Proton Pump Inhibitors, and Elimination Diets: Results from the Swiss Eosinophilic Esophagitis Cohort Study","author":"Safroneeva","year":"2024"},{"issue":"6","key":"10.1016\/j.cct.2024.107708_bb0070","doi-asserted-by":"crossref","first-page":"1776","DOI":"10.1053\/j.gastro.2020.02.038","article-title":"AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters clinical guidelines for the management of eosinophilic esophagitis","volume":"158","author":"Hirano","year":"2020","journal-title":"Gastroenterology"},{"issue":"25","key":"10.1016\/j.cct.2024.107708_bb0075","doi-asserted-by":"crossref","first-page":"2317","DOI":"10.1056\/NEJMoa2205982","article-title":"Dupilumab in adults and adolescents with eosinophilic esophagitis","volume":"387","author":"Dellon","year":"2022","journal-title":"N. Engl. J. Med."},{"issue":"5","key":"10.1016\/j.cct.2024.107708_bb0080","doi-asserted-by":"crossref","first-page":"1672","DOI":"10.1053\/j.gastro.2020.07.039","article-title":"Budesonide orodispersible tablets maintain remission in a randomized, placebo-controlled trial of patients with eosinophilic esophagitis","volume":"159","author":"Straumann","year":"2020","journal-title":"Gastroenterology"},{"issue":"1","key":"10.1016\/j.cct.2024.107708_bb0085","doi-asserted-by":"crossref","first-page":"74","DOI":"10.1053\/j.gastro.2019.03.025","article-title":"Efficacy of budesonide orodispersible tablets as induction therapy for eosinophilic esophagitis in a randomized placebo-controlled trial","volume":"157","author":"Lucendo","year":"2019","journal-title":"Gastroenterology"},{"issue":"1","key":"10.1016\/j.cct.2024.107708_bb0095","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1016\/j.anai.2022.10.004","article-title":"Current state of biologics in treating eosinophilic esophagitis","volume":"130","author":"Nhu","year":"2023","journal-title":"Ann. Allergy Asthma Immunol."},{"issue":"3","key":"10.1016\/j.cct.2024.107708_bb0100","doi-asserted-by":"crossref","first-page":"238","DOI":"10.3390\/gastroent13030024","article-title":"First therapeutic approval for eosinophilic esophagitis","volume":"13","author":"Al-Horani","year":"2022","journal-title":"Gastroenterol. Insights."},{"key":"10.1016\/j.cct.2024.107708_bb0105","author":"European Medicines Agency"},{"issue":"4","key":"10.1016\/j.cct.2024.107708_bb0110","doi-asserted-by":"crossref","first-page":"840","DOI":"10.1053\/j.gastro.2019.09.052","article-title":"Approaches and challenges to management of pediatric and adult patients with eosinophilic esophagitis","volume":"158","author":"Hirano","year":"2020","journal-title":"Gastroenterology"},{"issue":"20","key":"10.1016\/j.cct.2024.107708_bb0115","doi-asserted-by":"crossref","DOI":"10.3390\/cells12202473","article-title":"Mechanistic insights into eosinophilic esophagitis: therapies targeting pathophysiological mechanisms","volume":"12","author":"Massironi","year":"2023","journal-title":"Cells"},{"issue":"3","key":"10.1016\/j.cct.2024.107708_bb0120","doi-asserted-by":"crossref","first-page":"718","DOI":"10.1038\/mi.2013.90","article-title":"Desmoglein-1 regulates esophageal epithelial barrier function and immune responses in eosinophilic esophagitis","volume":"7","author":"Sherrill","year":"2014","journal-title":"Mucosal Immunol."},{"issue":"1","key":"10.1016\/j.cct.2024.107708_bb0125","doi-asserted-by":"crossref","first-page":"660","DOI":"10.4049\/jimmunol.1000471","article-title":"IL-13 induces esophageal remodeling and gene expression by an eosinophil-independent, IL-13R alpha 2-inhibited pathway","volume":"185","author":"Zuo","year":"2010","journal-title":"J. Immunol."},{"issue":"8","key":"10.1016\/j.cct.2024.107708_bb0130","doi-asserted-by":"crossref","first-page":"895","DOI":"10.1038\/ng.3033","article-title":"Genome-wide association analysis of eosinophilic esophagitis provides insight into the tissue specificity of this allergic disease","volume":"46","author":"Kottyan","year":"2014","journal-title":"Nat. Genet."},{"issue":"6","key":"10.1016\/j.cct.2024.107708_bb0135","doi-asserted-by":"crossref","first-page":"1364","DOI":"10.1007\/s12325-017-0525-8","article-title":"RPC4046, a novel anti-interleukin-13 antibody, blocks IL-13 binding to IL-13 alpha1 and alpha2 receptors: a randomized, double-blind, placebo-controlled, dose-escalation first-in-human study","volume":"34","author":"Tripp","year":"2017","journal-title":"Adv. Ther."},{"issue":"3","key":"10.1016\/j.cct.2024.107708_bb0140","doi-asserted-by":"crossref","first-page":"592","DOI":"10.1053\/j.gastro.2018.10.051","article-title":"RPC4046, a monoclonal antibody against IL13, reduces histologic and endoscopic activity in patients with eosinophilic esophagitis","volume":"156","author":"Hirano","year":"2019","journal-title":"Gastroenterology"},{"issue":"4","key":"10.1016\/j.cct.2024.107708_bb0145","doi-asserted-by":"crossref","first-page":"489","DOI":"10.1136\/gutjnl-2011-301817","article-title":"Endoscopic assessment of the oesophageal features of eosinophilic oesophagitis: validation of a novel classification and grading system","volume":"62","author":"Hirano","year":"2013","journal-title":"Gut"},{"issue":"3","key":"10.1016\/j.cct.2024.107708_bb0150","first-page":"1","article-title":"Newly developed and validated eosinophilic esophagitis histology scoring system and evidence that it outperforms peak eosinophil count for disease diagnosis and monitoring","volume":"30","author":"Collins","year":"2017","journal-title":"Dis. Esophagus"},{"issue":"3","key":"10.1016\/j.cct.2024.107708_bb0155","doi-asserted-by":"crossref","first-page":"473","DOI":"10.1016\/j.cgh.2020.03.036","article-title":"Long-term efficacy and tolerability of RPC4046 in an open-label extension trial of patients with eosinophilic esophagitis","volume":"19","author":"Dellon","year":"2021","journal-title":"Clin. Gastroenterol. Hepatol."},{"key":"10.1016\/j.cct.2024.107708_bb0160","author":"U.S. Food and Drug Administration"},{"issue":"3","key":"10.1016\/j.cct.2024.107708_bb0165","doi-asserted-by":"crossref","first-page":"220","DOI":"10.1097\/00005650-199603000-00003","article-title":"A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity","volume":"34","author":"Ware","year":"1996","journal-title":"Med. Care"},{"key":"10.1016\/j.cct.2024.107708_bb0170","series-title":"The SF-10 Health Survey for Children: A User\u2019s Guide","author":"Saris-Baglama","year":"2007"},{"issue":"8","key":"10.1016\/j.cct.2024.107708_bb0175","doi-asserted-by":"crossref","first-page":"1701","DOI":"10.1016\/j.cgh.2021.10.028","article-title":"A gap in care leads to progression of fibrosis in eosinophilic esophagitis patients","volume":"20","author":"Chang","year":"2022","journal-title":"Clin. Gastroenterol. Hepatol."},{"issue":"4","key":"10.1016\/j.cct.2024.107708_bb0180","doi-asserted-by":"crossref","DOI":"10.1093\/dote\/dox128","article-title":"Prospective assessment of disease-specific quality of life in adults with eosinophilic esophagitis","volume":"31","author":"Stern","year":"2018","journal-title":"Dis. Esophagus"},{"issue":"8","key":"10.1016\/j.cct.2024.107708_bb0185","doi-asserted-by":"crossref","DOI":"10.1093\/dote\/doy015","article-title":"Natural history of eosinophilic esophagitis: a systematic review of epidemiology and disease course","volume":"31","author":"Shaheen","year":"2018","journal-title":"Dis. Esophagus"},{"issue":"6","key":"10.1016\/j.cct.2024.107708_bb0190","doi-asserted-by":"crossref","first-page":"1230","DOI":"10.1053\/j.gastro.2013.08.015","article-title":"Delay in diagnosis of eosinophilic esophagitis increases risk for stricture formation in a time-dependent manner","volume":"145","author":"Schoepfer","year":"2013","journal-title":"Gastroenterology"},{"issue":"4","key":"10.1016\/j.cct.2024.107708_bb0195","doi-asserted-by":"crossref","first-page":"577","DOI":"10.1016\/j.gie.2013.10.027","article-title":"A phenotypic analysis shows that eosinophilic esophagitis is a progressive fibrostenotic disease","volume":"79","author":"Dellon","year":"2014","journal-title":"Gastrointest. Endosc."},{"issue":"2","key":"10.1016\/j.cct.2024.107708_bb0200","doi-asserted-by":"crossref","first-page":"134","DOI":"10.1097\/MCG.0000000000000297","article-title":"Impact of diagnostic delay and other risk factors on eosinophilic esophagitis phenotype and esophageal diameter","volume":"50","author":"Lipka","year":"2016","journal-title":"J. Clin. Gastroenterol."},{"issue":"6","key":"10.1016\/j.cct.2024.107708_bb0205","doi-asserted-by":"crossref","first-page":"836","DOI":"10.1038\/s41395-018-0052-5","article-title":"The natural course of eosinophilic esophagitis and long-term consequences of undiagnosed disease in a large cohort","volume":"113","author":"Warners","year":"2018","journal-title":"Am. J. Gastroenterol."},{"issue":"2","key":"10.1016\/j.cct.2024.107708_bb0210","doi-asserted-by":"crossref","first-page":"382","DOI":"10.1159\/000477391","article-title":"Progression from an inflammatory to a fibrostenotic phenotype in eosinophilic esophagitis","volume":"11","author":"Koutlas","year":"2017","journal-title":"Case Rep. Gastroenterol."},{"issue":"6","key":"10.1016\/j.cct.2024.107708_bb0215","doi-asserted-by":"crossref","first-page":"1292","DOI":"10.1016\/j.jaci.2007.10.024","article-title":"IL-13 involvement in eosinophilic esophagitis: transcriptome analysis and reversibility with glucocorticoids","volume":"120","author":"Blanchard","year":"2007","journal-title":"J. Allergy Clin. Immunol."},{"issue":"4","key":"10.1016\/j.cct.2024.107708_bb0220","doi-asserted-by":"crossref","first-page":"744","DOI":"10.14309\/ajg.0000000000002094","article-title":"Dysphagia days as an assessment of clinical treatment outcome in eosinophilic esophagitis","volume":"118","author":"Hirano","year":"2023","journal-title":"Am. J. Gastroenterol."},{"issue":"2","key":"10.1016\/j.cct.2024.107708_bb0225","doi-asserted-by":"crossref","first-page":"367","DOI":"10.1016\/j.jaci.2020.03.045","article-title":"An anti-IL-13 antibody reverses epithelial-mesenchymal transition biomarkers in eosinophilic esophagitis: phase 2 trial results","volume":"146","author":"Gann","year":"2020","journal-title":"J. Allergy Clin. Immunol."},{"issue":"1","key":"10.1016\/j.cct.2024.107708_bb0230","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1016\/j.jaci.2019.10.027","article-title":"Emerging therapies for eosinophilic esophagitis","volume":"145","author":"Greuter","year":"2020","journal-title":"J. Allergy Clin. Immunol."},{"issue":"7","key":"10.1016\/j.cct.2024.107708_bb0235","doi-asserted-by":"crossref","first-page":"1483","DOI":"10.1016\/j.cgh.2019.08.050","article-title":"Rapid recurrence of eosinophilic esophagitis activity after successful treatment in the observation phase of a randomized, double-blind, double-dummy trial","volume":"18","author":"Dellon","year":"2020","journal-title":"Clin. Gastroenterol. Hepatol."},{"issue":"10","key":"10.1016\/j.cct.2024.107708_bb0240","doi-asserted-by":"crossref","first-page":"1527","DOI":"10.1038\/ajg.2017.202","article-title":"Long-term treatment of eosinophilic esophagitis with swallowed topical corticosteroids: development and evaluation of a therapeutic concept","volume":"112","author":"Greuter","year":"2017","journal-title":"Am. J. Gastroenterol."}],"container-title":["Contemporary Clinical Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S155171442400291X?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S155171442400291X?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2024,12,2]],"date-time":"2024-12-02T09:01:05Z","timestamp":1733130065000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S155171442400291X"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12]]},"references-count":47,"alternative-id":["S155171442400291X"],"URL":"https:\/\/doi.org\/10.1016\/j.cct.2024.107708","relation":{},"ISSN":["1551-7144"],"issn-type":[{"value":"1551-7144","type":"print"}],"subject":[],"published":{"date-parts":[[2024,12]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Design of a phase 3, randomized, double-blind, placebo-controlled, 48-week study to evaluate the efficacy and safety of cendakimab in adult and adolescent patients with eosinophilic esophagitis","name":"articletitle","label":"Article Title"},{"value":"Contemporary Clinical Trials","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.cct.2024.107708","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2024 The Authors. Published by Elsevier Inc.","name":"copyright","label":"Copyright"}],"article-number":"107708"}}