Cendakimab for Eosinophilic Gastritis and Duodenitis in Japanese Adults and Adolescents: Results from a Phase 3 Randomized Controlled Trial
Yoshikazu Kinoshita1, Shiro Oka2, Kayoko Matsushima3
1Hyogo Prefectural Harima-Himeji General Medical Center, Hyogo, Japan.
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 vs 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.