drugset / Trial / NCT00538434

Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years

Phase 2/3 Completed 227 enrolled Ception Therapeutics

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This trial will study three doses of reslizumab versus placebo in children with eosinophilic esophagitis (EE). The objectives of the trial will be to study the effectiveness of reslizumab in improving the clinical signs and symptoms and reducing esophageal eosinophils as well as assessing the safety profile compared to placebo.

Timeline

Start: 2008-03
Primary completion: 2009-10
Completion: 2009-10

Outcome

Mixed primary results

registry Reslizumab 1 mg/kg vs Placebo; p < 0.0001; Adjusted mean difference -52.78 (95% CI -75.24 to -30.32); ANCOVA NCT00538434 ↗

registry Reslizumab 2 mg/kg vs Placebo; p < 0.0001; Adjusted mean difference -73.03 (95% CI -95.28 to -50.78); ANCOVA NCT00538434 ↗

registry Reslizumab 3 mg/kg vs Placebo; p < 0.0001; Adjusted mean difference -64.69 (95% CI -86.93 to -42.45); ANCOVA NCT00538434 ↗

registry MEAN Reslizumab 1 mg/kg: -0.85 (Standard Deviation NA) units on a scale NCT00538434 ↗

registry MEAN Placebo: -1.14 (Standard Deviation NA) units on a scale NCT00538434 ↗

registry Reslizumab 1 mg/kg vs Placebo; p = 0.0313; Cochran-Mantel-Haenszel NCT00538434 ↗

registry Reslizumab 2 mg/kg vs Placebo; p = 0.5793; Cochran-Mantel-Haenszel NCT00538434 ↗

registry Reslizumab 3 mg/kg vs Placebo; p = 0.4905; Cochran-Mantel-Haenszel NCT00538434 ↗

Publications

Results Spergel JM, Rothenberg ME, Collins MH, Furuta GT, Markowitz JE, Fuchs G 3rd, O'Gorman MA, Abonia JP, Young J, Henkel T, Wilkins HJ, Liacouras CA. Reslizumab in children and adolescents with eosinophilic esophagitis: results of a double-blind, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2012 Feb;129(2):456-63, 463.e1-3. doi: 10.1016/j.jaci.2011.11.044. Epub 2011 Dec 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Reslizumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Reslizumab	Monoclonal antibody	2 mg/kg	Intravenous
Subject	Reslizumab	Monoclonal antibody	3 mg/kg	Intravenous