Safety and Tolerability of Nexvax2 in Subjects With Celiac Disease

Summary

A randomized, double-blind, placebo-controlled, dose titration trial, stratified by Human Leukocyte Antigen (HLA)-DQ2.5 genotype in subjects with celiac disease.

Timeline

Start

2015-08

Primary completion

2017-01-06

Completion

2017-01-06

Publications

• Daveson AJM, Ee HC, Andrews JM, King T, Goldstein KE, Dzuris JL, MacDougall JA, Williams LJ, Treohan A, Cooreman MP, Anderson RP. Epitope-Specific Immunotherapy Targeting CD4-Positive T Cells in Celiac Disease: Safety, Pharmacokinetics, and Effects on Intestinal Histology and Plasma Cytokines with Escalating Dose Regimens of Nexvax2 in a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. EBioMedicine. 2017 Dec;26:78-90. doi: 10.1016/j.ebiom.2017.11.018. Epub 2017 Nov 22.

Drugs

Indications