OP18 The UNITI Jr Study: Safety and efficacy results of ustekinumab in paediatric patients with Crohn’s Disease

Journal of Crohn s and Colitis 2026

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Authors: D Turner, E De Greef, J Kierkuś, Bartosz Korczowski, Monika Meglicka, R K Russell, S Cohen, Jeffrey S. Hyams, A Griffiths, J Rosh, R Strauss, E Van Limbergen
+3 more O Adedokun, L Kim, Sheri Volger
DOI: 10.1093/ecco-jcc/jjaf231.018
Cited by: 2

Abstract

Abstract Background Ustekinumab therapy induced and maintained response and remission in adult patients with moderate-to-severe Crohn’s disease (CD) in the IM-UNITI program.1,2 The UNITI Jr study (NCT04673357) evaluated efficacy and safety of ustekinumab in paediatric participants with moderately-to-severely-active CD. Methods 101 participants (≥2 – 30; inadequate response/intolerant to conventional/biologic therapy or corticosteroid-dependent) received 1 open-label intravenous ustekinumab (Induction) dose. At Week (W)8, 97 participants were randomized (1:1) stratified by baseline body weight (30/non-responder PCDAI decline

Fields of Study & Subjects

Inflammatory Bowel Disease Autoimmune and Inflammatory Disorders Research Biosimilars and Bioanalytical Methods

Publication details

Journal / source
Journal of Crohn s and Colitis
Publisher
Oxford University Press (OUP)
Volume
20
Issue
Supplement_1
Publication date
1 January 2026
Language
EN