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Safety and Tolerability of Nexvax2 in Subjects With Celiac Disease

Celiac Disease Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Nexvax2 Preceded by a Dose Titration Period in Subjects With Celiac Disease Currently on a Gluten-Free Diet

Clinical Trial Summary

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

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, study to evaluate the safety and tolerability of Nexvax2 preceded by dose titration period in patients with celiac disease currently on a gluten-free diet. The study will consist of a Screening Period, a Treatment Period, and a Follow-up Period. Eligible subjects will be enrolled in one of three cohorts according to whether they are homozygous or not homozygous for both genes coding for HLA-DQ2.5. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02528799
Study type Interventional
Source ImmusanT, Inc.
Contact
Status Completed
Phase Phase 1
Start date August 2015
Completion date January 6, 2017
View Details
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