{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,12]],"date-time":"2026-04-12T21:44:53Z","timestamp":1776030293120,"version":"3.50.1"},"reference-count":0,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T00:00:00Z","timestamp":1775779200000},"content-version":"am","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>ABBV-154 is an antibody-drug conjugate of adalimumab and a proprietary glucocorticoid receptor modulator. This phase 2\u2009b randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of ABBV-154 versus placebo in patients with moderately to severely active Crohn\u2019s disease who had inadequate response to or were intolerant of prior biologic therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients were randomized 1:1:1:1:1 to ABBV-154 induction groups: 150\u2009mg IV at week 0, then 80\u2009mg SC at week 2 and every other week (EOW); 300\u2009mg IV at week 0, then 230\u2009mg SC at week 2 and EOW; 600\u2009mg IV at week 0, then 530\u2009mg SC at week 2 and EOW; 600\u2009mg IV at week 0, then 530\u2009mg SC at weeks 4 and 8, and placebo at weeks 2, 6, and 10; or placebo. The primary endpoint was achievement of endoscopic response per SES-CD by central review at week 12. Adverse events were monitored throughout.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 265 planned patients, 106 were randomized and treated until completion, discontinuation, or early study termination by the sponsor. At week 12, greater proportions of patients treated with ABBV-154 achieved endoscopic response versus placebo (7.1%, 33.3%, 28.6%, and 27.3% across the induction groups versus 0%; data reported as observed). Adverse events were comparable across all ABBV-154 groups and slightly higher than placebo through week 12.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>ABBV-154 was well tolerated and demonstrated proof-of-concept for efficacy in patients with moderately to severely active Crohn\u2019s disease. Results should be interpreted with caution due to early study termination.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/crocol\/otag014","type":"journal-article","created":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T11:50:45Z","timestamp":1775735445000},"source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and Safety of ABBV-154 in Patients With Moderately-to-Severely Active Crohn\u2019s Disease: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial"],"prefix":"10.1093","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2088-091X","authenticated-orcid":false,"given":"Walter","family":"Reinisch","sequence":"first","affiliation":[{"name":"Medical University of Vienna Department of Internal Medicine, , Vienna,","place":["Austria"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2536-6618","authenticated-orcid":false,"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[{"name":"CHRU Nancy, INSERM NGERE, Universit\u00e9 de Lorraine Department of Gastroenterology, , F-54500, Vand\u0153uvre-l\u00e8s-Nancy, France; Division of Gastroenterology and Hepatology, , Montreal, Quebec,","place":["Canada"]},{"name":"McGill University Health Centre Department of Gastroenterology, , F-54500, Vand\u0153uvre-l\u00e8s-Nancy, France; Division of Gastroenterology and Hepatology, , Montreal, Quebec,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2784-4046","authenticated-orcid":false,"given":"Geert","family":"D\u2019Haens","sequence":"additional","affiliation":[{"name":"Amsterdam University Medical Centers Department of Gastroenterology, , Amsterdam, The","place":["Netherlands"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreas","family":"Sturm","sequence":"additional","affiliation":[{"name":"German Red Cross Hospital Berlin Department of Internal Medicine\u2014Gastroenterology, , Berlin,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0893-3900","authenticated-orcid":false,"given":"Jaclyn K","family":"Anderson","sequence":"additional","affiliation":[{"name":"AbbVie Inc , ., North Chicago, IL,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5260-2009","authenticated-orcid":false,"given":"Izabella","family":"Messina","sequence":"additional","affiliation":[{"name":"AbbVie Inc , ., North Chicago, IL,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dilek","family":"Arikan","sequence":"additional","affiliation":[{"name":"AbbVie Inc , ., North Chicago, IL,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alissa","family":"Zimmerman-Bennett","sequence":"additional","affiliation":[{"name":"AbbVie Inc , ., North Chicago, IL,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julie","family":"Parmentier","sequence":"additional","affiliation":[{"name":"AbbVie Inc , ., North Chicago, IL,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tian","family":"Feng","sequence":"additional","affiliation":[{"name":"AbbVie Inc , ., North Chicago, IL,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1317-9105","authenticated-orcid":false,"given":"Ronilda","family":"D\u2019Cunha","sequence":"additional","affiliation":[{"name":"AbbVie Inc , ., North Chicago, IL,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreas","family":"Lazar","sequence":"additional","affiliation":[{"name":"AbbVie Deutschland GmbH & Co. KG , Ludwigshafen,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1287-7075","authenticated-orcid":false,"given":"Edouard","family":"Louis","sequence":"additional","affiliation":[{"name":"Centre Hospitalier Universitaire de Li\u00e8ge Department of Gastroenterology, , Li\u00e8ge,","place":["Belgium"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2026,4,9]]},"container-title":["Crohn's &amp; Colitis 360"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/advance-article-pdf\/doi\/10.1093\/crocol\/otag014\/68021318\/otag014.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/advance-article-pdf\/doi\/10.1093\/crocol\/otag014\/68021318\/otag014.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,12]],"date-time":"2026-04-12T21:19:17Z","timestamp":1776028757000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/advance-article\/doi\/10.1093\/crocol\/otag014\/8650785"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,9]]},"references-count":0,"URL":"https:\/\/doi.org\/10.1093\/crocol\/otag014","relation":{},"ISSN":["2631-827X"],"issn-type":[{"value":"2631-827X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,9]]},"article-number":"otag014"}}