Cendakimab for Eosinophilic Gastritis and Duodenitis in Japanese Adults and Adolescents: Results From a Phase 3 Randomized Controlled Trial
In brief
Cendakimab cuts gastric eosinophil count by about 223 cells per high power field
In a phase 3 trial of 48 Japanese patients with eosinophilic gastritis or duodenitis, cendakimab lowered peak gastrointestinal eosinophil levels by roughly 223 cells per high-power field at 16 weeks compared with placebo, with symptom scores also trending upward. The histologic benefit persisted to week 48 and safety was favorable, suggesting IL-13 blockade as a promising therapeutic avenue, though larger studies are needed to confirm clinical impact.
- Journal
- The American journal of gastroenterology (Q1)
- Published
- 28 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Yoshikazu Kinoshita, Shiro Oka, Kayoko Matsushima, Mikinori Kataoka, Tsuyoshi Sanuki, Yasuhiro Fujiwara, et al.
- PMID
- 42669462
- DOI
- 10.14309/ajg.0000000000004192
Why clinicians should know about it
- Picked for Histology (top studies of the week, 6 September 2026): Phase III RCT reduces eosinophil counts
Abstract
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.