Eldelumab [Anti-IP-10] induction therapy for ulcerative colitis: A randomised, placebo-controlled, phase 2b study

William J. Sandborn*, Jean Frédéric Colombel, Subrata Ghosh, Bruce E. Sands, Gerald Dryden, Xavier Hébuterne, Rupert W. Leong, Brian Bressler, Thomas Ullman, Peter L. Lakatos, Walter Reinisch, Li An Xu, Allison Luo

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

25 Citations (Scopus)

Abstract

Background and Aims: Interferon-γ-inducible protein-10 [IP-10] mediates immune cell trafficking from the circulation to the inflamed colon and decreases gut epithelial cell survival. IP-10 expression is increased in patients with ulcerative colitis [UC]. We report efficacy and safety results from a dose-ranging induction study of eldelumab, a fully human monoclonal antibody to IP-10, in moderately to severely active UC. Methods: A total of 252 adults with UC [Mayo score ≥ 6 and endoscopic subscore ≥ 2] were randomised 1:1:1 to placebo or eldelumab 15 or 25 mg/kg administered intravenously on Days 1 and 8 and every other week thereafter. The primary endpoint was clinical remission [Mayo score ≤ 2; no individual subscale score > 1] at Week 11. Key secondary endpoints included Mayo score clinical response and mucosal healing at Week 11. Results: Neither eldelumab 15 or 25 mg/kg resulted in significant increases vs placebo in the proportion of patients achieving Week 11 clinical remission. Remission and response rates were 17.6% and 47.1% with eldelumab 25 mg/kg, 13.1% and 44.0% with eldelumab 15 mg/kg, and 9.6% and 31.3% with placebo. Clinical remission and response rates were higher in anti-tumour necrosis factor [TNF]-naïve patients treated with eldelumab compared with placebo. Eldelumab treatment was well tolerated and no immunogenicity was observed. Conclusions: The primary endpoint was not achieved with induction treatment with eldelumab 15 or 25 mg/kg in patients with UC. Trends towards clinical remission and response were observed in the overall population and were more pronounced in anti-TNF naïve patients. Eldelumab safety signals were consistent with those reported previously [ClinicalTrials.gov number, NCT01294410].

Original languageEnglish
Pages (from-to)418-428
Number of pages11
JournalJournal of Crohn's and Colitis
Volume10
Issue number4
DOIs
Publication statusPublished - 1 Apr 2016
Externally publishedYes

Keywords

  • Inflammatory bowel diseases
  • Ulcerative colitis

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