Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study
William J Sandborn1, Jean-Frédéric Colombel2, Subrata Ghosh3
1Inflammatory Bowel Disease Center, University of California San Diego, La Jolla, CA, USA wsandborn@ucsd.edu.
Journal of Crohn'S & Colitis
|January 2, 2016
Summary
Eldelumab, an antibody targeting Interferon-γ-inducible protein-10 (IP-10), did not significantly improve clinical remission in ulcerative colitis (UC) patients. However, trends suggest potential benefit in anti-TNF-naïve individuals, with eldelumab showing a favorable safety profile.
Area of Science:
- Immunology
- Gastroenterology
- Pharmacology
Background:
- Interferon-γ-inducible protein-10 (IP-10) plays a role in immune cell trafficking and gut epithelial cell survival.
- Increased IP-10 expression is observed in patients with ulcerative colitis (UC).
Purpose of the Study:
- To evaluate the efficacy and safety of eldelumab, a monoclonal antibody targeting IP-10, in patients with moderately to severely active UC.
- To conduct a dose-ranging induction study of eldelumab.
Main Methods:
- 252 adults with UC were randomized to receive placebo or eldelumab (15 or 25 mg/kg) intravenously.
- Treatment was administered on Days 1 and 8, and every other week thereafter.
- The primary endpoint was clinical remission at Week 11, with secondary endpoints including clinical response and mucosal healing.
Main Results:
- Neither eldelumab dose achieved significant increases in clinical remission compared to placebo at Week 11.
- Clinical remission and response rates were numerically higher with eldelumab, particularly in anti-TNF-naïve patients.
- Eldelumab was well-tolerated, with no observed immunogenicity.
Conclusions:
- The primary endpoint of clinical remission was not met with eldelumab induction therapy in UC patients.
- Trends towards clinical remission and response were observed, especially in anti-TNF-naïve patients.
- Eldelumab demonstrated a safety profile consistent with previous reports.
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