An Early Phase 2 Double-Blind, Placebo-Controlled Study of E6011, a Novel Anti-Fractalkine Antibody, in Patients with Crohn's Disease.

ABSTRACT:

Introduction

E6011 is a newly developed humanized monoclonal antibody that binds to and neutralizes fractalkine with high specificity and affinity. In a previous phase 1, open-label study, E6011 demonstrated good tolerability and preliminary efficacy in Japanese patients with mild to moderate active Crohn's disease (CD).

Methods

In this early phase 2, double-blind, placebo-controlled study, we examined the efficacy and safety of E6011 in patients with moderate to severe active CD in a 12-week, double-blind period and the long-term efficacy and safety of E6011 in a subsequent open-label period for a maximum of 52 weeks. The primary efficacy endpoint was the percentage of patients who achieved a decrease in the CD activity index (CDAI) by ≥100 points from baseline at week 12.<

SUBMITTER: Kobayashi T 

PROVIDER: S-EPMC12659157 | biostudies-literature | 2025 Jan-Dec

REPOSITORIES: biostudies-literature