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

Kinoshita, Yoshikazu; Oka, Shiro; Matsushima, Kayoko; Kataoka, Mikinori; Sanuki, Tsuyoshi; Fujiwara, Yasuhiro; Arai, Katsuhiro; Midorikawa, Shuichi et al. · Am J Gastroenterol · 2026

rct · Level II

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Abstract

Eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD; EG/EoD) are rare, chronic inflammatory disorders lacking approved treatments. 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. 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. These findings highlight IL-13 inhibition as a potential treatment strategy for EG/EoD.