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.

•Maximum tolerated doses of peptide-based epitope-specific immunotherapy for celiac disease are increased by dose escalation.•Starting dose rather than maximum dose during up-dosing determine tolerability of Nexvax2 in celiac disease patients.•After up-dosing, systemic exposure to antigenic peptides in Nexvax2 is not associated with cytokine release or symptoms.