{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T02:21:51Z","timestamp":1793931711694,"version":"4.8.0"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T00:00:00Z","timestamp":1773187200000},"content-version":"vor","delay-in-days":314,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Connect Biopharma","id":[{"id":"https:\/\/ror.org\/02n35rf33","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Connect Biopharma","id":[{"id":"https:\/\/ror.org\/02n35rf33","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["www.atsjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,5,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>Rademikibart (formerly CBP-201) is an IL-4R\u03b1\u2013targeting antibody.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>We sought to evaluate rademikibart in adults with moderate-to-severe, persistent, uncontrolled asthma.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this global Phase 2b trial, 322 patients were randomized 1:1:1 to two rademikibart groups (150 mg or 300 mg every other week, after a 600-mg loading dose) or a placebo group; rademikibart or placebo was administered subcutaneously for 24 weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Measurements and Main Results<\/jats:title>\n                    <jats:p>Prebronchodilator (trough) forced expiratory volume in 1 second (FEV1) at Week 12 (primary endpoint) improved with rademikibart at 150 mg and 300 mg: Least squares mean changes (95% confidence interval), above placebo, were 140 ml (44\u2013236 ml; P\u2009=\u20090.005) and 189 ml (92\u2013286 ml; P\u2009&amp;lt;\u20090.001), respectively. Prebronchodilator (trough) FEV1 improvements occurred rapidly during Week 1, were sustained through Week 24, and were greatest in patients with high baseline blood eosinophils (patients with \u2a7e300 eosinophils\/ml experienced placebo-adjusted FEV1 improvement at Week 24 of 420 ml [95% confidence interval\u2009=\u2009 239\u2013600 ml] in the 300-mg group). Rapid and sustained statistically significant improvements were also observed in percent predicted FEV1 and Asthma Control Questionnaire score across 24 weeks. Through Week 24, proportions of patients with one or more exacerbations were 7.5% (150 mg) and 9.3% (300 mg) versus 16.7% (placebo). Eighty-eight percent of patients completed treatment. Treatment-emergent adverse events were generally similar to placebo, and no eosinophilia was observed. Injection site reactions were mostly mild. The most common treatment-emergent adverse events (10\u201312% of patients) were cough, coronavirus disease (COVID-19), and dyspnea.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Rapid and sustained improvements in lung function and asthma control were gained across 24 weeks of rademikibart therapy.<\/jats:p>\n                    <jats:p>Clinical trial registered with www.clinicaltrials.gov (NCT 04773678).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1164\/rccm.202409-1708oc","type":"journal-article","created":{"date-parts":[[2025,2,25]],"date-time":"2025-02-25T10:57:57Z","timestamp":1740481077000},"page":"749-758","update-policy":"https:\/\/doi.org\/10.1164\/crossmarkpolicies","source":"Crossref","is-referenced-by-count":7,"title":["Rademikibart Treatment for Moderate-to-Severe Uncontrolled Asthma: A Phase 2B Randomized Clinical Trial"],"prefix":"10.1093","volume":"211","author":[{"given":"Edward","family":"Kerwin","sequence":"first","affiliation":[{"name":"Clinical Research Institute, Allergy and Asthma Center of Southern Oregon, Medford, Oregon"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ting","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, National Clinical Research Center for Respiratory Disease, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nan","family":"Su","sequence":"additional","affiliation":[{"name":"Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, National Clinical Research Center for Respiratory Disease, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiawang","family":"Guo","sequence":"additional","affiliation":[{"name":"Suzhou Connect Biopharmaceuticals Ltd., Taicang, China; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Radha","family":"Adivikolanu","sequence":"additional","affiliation":[{"name":"Connect Biopharma, LLC, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malinda","family":"Longphre","sequence":"additional","affiliation":[{"name":"Connect Biopharma, LLC, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junying","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, National Clinical Research Center for Respiratory Disease, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jili","family":"Yun","sequence":"additional","affiliation":[{"name":"Suzhou Connect Biopharmaceuticals Ltd., Taicang, China; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wuban","family":"Pan","sequence":"additional","affiliation":[{"name":"Suzhou Connect Biopharmaceuticals Ltd., Taicang, China; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zheng","family":"Wei","sequence":"additional","affiliation":[{"name":"Connect Biopharma, LLC, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ra\u00fal","family":"Collazo","sequence":"additional","affiliation":[{"name":"Connect Biopharma, LLC, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,5,1]]},"reference":[{"key":"2026031105320745000_bib1","article-title":"Asthma data visualizations","year":"2023"},{"key":"2026031105320745000_bib2","first-page":"825","article-title":"Incremental cost burden among patients with severe uncontrolled asthma in the United States","volume":"29","author":"Burnette","year":"2023","journal-title":"J Manag Care Spec Pharm"},{"key":"2026031105320745000_bib3","doi-asserted-by":"crossref","first-page":"AB126","DOI":"10.1016\/j.jaci.2012.12.1118","article-title":"Estimated prevalence and economic burden of severe, uncontrolled asthma in the United States","volume":"131","author":"Hankin","year":"2013","journal-title":"J Allergy Clin Immunol"},{"key":"2026031105320745000_bib4","doi-asserted-by":"crossref","first-page":"106670","DOI":"10.1016\/j.rmed.2021.106670","article-title":"A systematic literature review of burden of illness in adults with uncontrolled moderate\/severe asthma","volume":"191","author":"Czira","year":"2022","journal-title":"Respir Med"},{"key":"2026031105320745000_bib5","doi-asserted-by":"crossref","first-page":"348","DOI":"10.1513\/AnnalsATS.201703-259OC","article-title":"The economic burden of asthma in the United States, 2008\u20132013","volume":"15","author":"Nurmagambetov","year":"2018","journal-title":"Ann Am Thorac Soc"},{"key":"2026031105320745000_bib6","doi-asserted-by":"crossref","first-page":"1900900","DOI":"10.1183\/13993003.00900-2019","article-title":"ERS\/EAACI statement on severe exacerbations in asthma in adults: facts, priorities and key research questions","volume":"54","author":"Bourdin","year":"2019","journal-title":"Eur Respir J"},{"key":"2026031105320745000_bib7","doi-asserted-by":"crossref","first-page":"1684","DOI":"10.3390\/biomedicines9111684","article-title":"Characterization of T2-low and T2-high asthma phenotypes in real-life","volume":"9","author":"Ricciardolo","year":"2021","journal-title":"Biomedicines"},{"key":"2026031105320745000_bib8","doi-asserted-by":"crossref","first-page":"2192288","DOI":"10.1183\/13993003.02288-2021","article-title":"T2-high asthma phenotypes across lifespan","volume":"60","author":"Maison","year":"2022","journal-title":"Eur Respir J"},{"key":"2026031105320745000_bib9","doi-asserted-by":"crossref","first-page":"546","DOI":"10.1111\/cea.13790","article-title":"Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma","volume":"51","author":"Chen","year":"2021","journal-title":"Clin Exp Allergy"},{"key":"2026031105320745000_bib10","doi-asserted-by":"crossref","first-page":"1267","DOI":"10.1016\/j.jaip.2020.09.051","article-title":"The prevalence of subtypes of type 2 inflammation in an unselected population of patients with severe asthma","volume":"9","author":"Fr\u00f8ssing","year":"2021","journal-title":"J Allergy Clin Immunol Pract"},{"key":"2026031105320745000_bib11","article-title":"Global strategy for asthma management and prevention","year":"2024"},{"key":"2026031105320745000_bib12","doi-asserted-by":"crossref","first-page":"12411","DOI":"10.1038\/s41598-023-39311-2","article-title":"Preclinical immunological characterization of rademikibart (CBP-201), a next-generation human monoclonal antibody targeting IL-4R\u03b1, for the treatment of Th2 inflammatory diseases","volume":"13","author":"Zhang","year":"2023","journal-title":"Sci Rep"},{"key":"2026031105320745000_bib13","doi-asserted-by":"crossref","first-page":"2614","DOI":"10.1111\/cts.13656","article-title":"Rademikibart (CBP-201), a next-generation monoclonal antibody targeting human IL-4R\u03b1: two phase I randomized trials, in healthy individuals and patients with atopic dermatitis","volume":"16","author":"Wang","year":"2023","journal-title":"Clin Transl Sci"},{"key":"2026031105320745000_bib14","doi-asserted-by":"crossref","first-page":"1040","DOI":"10.1016\/j.jaci.2023.11.924","article-title":"Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4R\u03b1, in adults with moderate to severe atopic dermatitis: a phase 2 randomized trial (CBP-201-WW001)","volume":"153","author":"Silverberg","year":"2024","journal-title":"J Allergy Clin Immunol"},{"key":"2026031105320745000_bib15","doi-asserted-by":"crossref","first-page":"3019","DOI":"10.1007\/s13555-023-01052-5","article-title":"A mini review of the impact of baseline disease severity on clinical outcomes: should we compare atopic dermatitis clinical trials?","volume":"13","author":"Silverberg","year":"2023","journal-title":"Dermatol Ther (Heidelb)"},{"key":"2026031105320745000_bib16","doi-asserted-by":"crossref","first-page":"e70","DOI":"10.1164\/rccm.201908-1590ST","article-title":"Standardization of spirometry 2019 update. An official American Thoracic Society and European Respiratory Society technical statement","volume":"200","author":"Graham","year":"2019","journal-title":"Am J Respir Crit Care Med"},{"key":"2026031105320745000_bib17","doi-asserted-by":"crossref","first-page":"553","DOI":"10.1016\/j.rmed.2004.10.008","article-title":"Measurement properties and interpretation of three shortened versions of the Asthma Control Questionnaire","volume":"99","author":"Juniper","year":"2005","journal-title":"Respir Med"},{"key":"2026031105320745000_bib18","doi-asserted-by":"crossref","first-page":"616","DOI":"10.1016\/j.rmed.2005.08.012","article-title":"Identifying \u2018well-controlled\u2019 and \u2018not well-controlled\u2019 asthma using the Asthma Control Questionnaire","volume":"100","author":"Juniper","year":"2006","journal-title":"Respir Med"},{"key":"2026031105320745000_bib19","doi-asserted-by":"crossref","first-page":"698","DOI":"10.1016\/j.rmed.2010.11.004","article-title":"Validation and agreement across four versions of the Asthma Control Questionnaire in patients with persistent asthma","volume":"105","author":"Wyrwich","year":"2011","journal-title":"Respir Med"},{"key":"2026031105320745000_bib20","doi-asserted-by":"crossref","first-page":"948","DOI":"10.1183\/09031936.05.00035205","article-title":"Interpretative strategies for lung function tests","volume":"26","author":"Pellegrino","year":"2005","journal-title":"Eur Respir J"},{"key":"2026031105320745000_bib21","doi-asserted-by":"crossref","first-page":"2486","DOI":"10.1056\/NEJMoa1804092","article-title":"Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma","volume":"378","author":"Castro","year":"2018","journal-title":"N Engl J Med"},{"key":"2026031105320745000_bib22","doi-asserted-by":"crossref","first-page":"1198","DOI":"10.1056\/NEJMoa1403290","article-title":"Mepolizumab treatment in patients with severe eosinophilic asthma","volume":"371","author":"Ortega","year":"2014","journal-title":"N Engl J Med"},{"key":"2026031105320745000_bib23","doi-asserted-by":"crossref","first-page":"390","DOI":"10.1016\/S2213-2600(17)30125-X","article-title":"Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial","volume":"5","author":"Chupp","year":"2017","journal-title":"Lancet Respir Med"},{"key":"2026031105320745000_bib24","doi-asserted-by":"crossref","first-page":"355","DOI":"10.1016\/S2213-2600(15)00042-9","article-title":"Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials","volume":"3","author":"Castro","year":"2015","journal-title":"Lancet Respir Med"},{"key":"2026031105320745000_bib25","doi-asserted-by":"crossref","first-page":"2115","DOI":"10.1016\/S0140-6736(16)31324-1","article-title":"Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting \u03b22-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial","volume":"388","author":"Bleecker","year":"2016","journal-title":"Lancet"},{"key":"2026031105320745000_bib26","doi-asserted-by":"crossref","first-page":"1800","DOI":"10.1056\/NEJMoa2034975","article-title":"Tezepelumab in adults and adolescents with severe, uncontrolled asthma","volume":"384","author":"Menzies-Gow","year":"2021","journal-title":"N Engl J Med"},{"key":"2026031105320745000_bib27","doi-asserted-by":"crossref","first-page":"2695","DOI":"10.1016\/j.jaip.2022.05.019","article-title":"Effect of dupilumab on blood eosinophil counts in patients with asthma, chronic rhinosinusitis with nasal polyps, atopic dermatitis, or eosinophilic esophagitis","volume":"10","author":"Wechsler","year":"2022","journal-title":"J Allergy Clin Immunol Pract"},{"key":"2026031105320745000_bib28","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1016\/S0140-6736(16)30307-5","article-title":"Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting \u03b22 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial","volume":"388","author":"Wenzel","year":"2016","journal-title":"Lancet"},{"key":"2026031105320745000_bib29","doi-asserted-by":"crossref","first-page":"459","DOI":"10.1111\/bjd.17869","article-title":"Conjunctivitis in dupilumab clinical trials","volume":"181","author":"Akinlade","year":"2019","journal-title":"Br J Dermatol"},{"key":"2026031105320745000_bib30","doi-asserted-by":"crossref","first-page":"40","DOI":"10.1016\/S0140-6736(15)00388-8","article-title":"Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial","volume":"387","author":"Tha\u00e7i","year":"2016","journal-title":"Lancet"},{"key":"2026031105320745000_bib31","doi-asserted-by":"crossref","first-page":"529","DOI":"10.1097\/JXX.0000000000000088","article-title":"Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults: a pooled analysis of two phase 2 clinical trials","volume":"30","author":"Tofte","year":"2018","journal-title":"J Am Assoc Nurse Pract"},{"key":"2026031105320745000_bib32","doi-asserted-by":"crossref","first-page":"2335","DOI":"10.1056\/NEJMoa1610020","article-title":"Two phase 3 trials of dupilumab versus placebo in atopic dermatitis","volume":"375","author":"Simpson","year":"2016","journal-title":"N Engl J Med"},{"key":"2026031105320745000_bib33","doi-asserted-by":"crossref","first-page":"266","DOI":"10.1016\/j.jdermsci.2019.02.002","article-title":"Efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis: a pooled analysis of two phase 3 randomized trials (LIBERTY AD SOLO 1 and LIBERTY AD SOLO 2)","volume":"94","author":"Tha\u00e7i","year":"2019","journal-title":"J Dermatol Sci"},{"key":"2026031105320745000_bib34","doi-asserted-by":"crossref","first-page":"633","DOI":"10.1111\/bjd.20690","article-title":"The efficacy and safety of dupilumab in Chinese patients with moderate-to-severe atopic dermatitis: a randomized, double-blind, placebo-controlled study","volume":"186","author":"Zhao","year":"2022","journal-title":"Br J Dermatol"}],"container-title":["American Journal of Respiratory and Critical Care Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ajrccm\/article-pdf\/211\/5\/749\/67295540\/ajrccm_211_5_749.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ajrccm\/article-pdf\/211\/5\/749\/67295540\/ajrccm_211_5_749.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T09:32:20Z","timestamp":1773221540000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ajrccm\/article\/211\/5\/749\/8513576"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,1]]},"references-count":34,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2025,5,1]]},"published-print":{"date-parts":[[2025,5,1]]}},"URL":"https:\/\/doi.org\/10.1164\/rccm.202409-1708oc","relation":{},"ISSN":["1073-449X","1535-4970"],"issn-type":[{"value":"1073-449X","type":"print"},{"value":"1535-4970","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,5]]},"published":{"date-parts":[[2025,5,1]]},"assertion":[{"value":"2024-09-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-02-25","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-01","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}