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

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24 Citations (Scopus)


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 25mg/kg, 13.1% and 44.0% with eldelumab 15mg/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)418-28
Number of pages11
JournalJournal of Crohn's & Colitis
Issue number4
Early online date30 Dec 2015
Publication statusPublished - Apr 2016


  • Adolescent
  • Adult
  • Aged
  • Antibodies, Monoclonal
  • Chemokine CXCL10
  • Colitis, Ulcerative
  • Female
  • Gastrointestinal Agents
  • Humans
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Remission Induction
  • Young Adult
  • Clinical Trial, Phase II
  • Journal Article
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't


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