Cendakimab for Eosinophilic Gastritis and Duodenitis in Japanese Adults and Adolescents: Results From a Phase 3 Randomized Controlled Trial.

INTRODUCTION

Eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD; EG/EoD) are rare, chronic inflammatory disorders lacking approved treatments.

METHODS

We report a randomized, double-blind, placebo-controlled phase 3 trial evaluating cendakimab, an anti-IL-13 monoclonal antibody, in 48 Japanese patients with EG/EoD.

RESULTS

At week 16, cendakimab significantly reduced mean peak gastrointestinal eosinophil counts versus placebo (least squares mean difference -223.2 eosinophils/high-power field; P=0.003), with numerical improvements across symptom domains. Histologic effects were maintained at week 48 and a favorable safety profile was observed.

DISCUSSION: These findings highlight IL-13 inhibition as a potential treatment strategy for EG/EoD.