Mepo for Eosinophilic Esophagitis (EoE) Study

Phase 2 Completed 66 enrolled University of North Carolina, Chapel Hill GlaxoSmithKline · collab MNGI Digestive Health, P.A. · collab Northwestern University · collab University of Utah · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

Multi-center, randomized, double blind, parallel-arm, placebo controlled trial to determine whether mepolizumab is more effective than placebo for improving symptoms of dysphagia and decreasing esophageal eosinophil counts in adults and adolescents with active eosinophilic esophagitis (EoE) after an initial 3 month treatment course, and will also assess the impact of an additional 3 months of treatment.

Timeline

Start: 2019-03-20
Primary completion: 2022-06-06
Completion: 2022-12-09

Outcome

Missed primary endpoint

paper Mepolizumab did not achieve the primary endpoint of improving dysphagia symptoms compared with placebo. PMID 37423717 ↗

registry analysis (superiority test); Mepolizumab 300 mg vs Placebo, Followed by Mepolizumab 100 mg; p = 0.14; ANCOVA NCT03656380 ↗

Publications

Dellon ES, Peterson KA, Mitlyng BL, Iuga A, Bookhout CE, Cortright LM, Walker KB, Gee TS, McGee SJ, Cameron BA, Galanko JA, Woosley JT, Eluri S, Moist SE, Hirano I. Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial. Gut. 2023 Oct;72(10):1828-1837. doi: 10.1136/gutjnl-2023-330337. Epub 2023 Jul 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mepolizumab	Monoclonal antibody	100 mg	Subcutaneous
Subject	Mepolizumab	Monoclonal antibody	300 mg	Subcutaneous