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A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)

Celiac Disease Clinical Trial

Official title:
A Phase 2 Randomized, Double-blind, Placebo-controlled Study in HLA-DQ2.5+ Adults With Celiac Disease to Assess the Effect of Nexvax2 on Symptoms After Masked Gluten Food Challenge

Clinical Trial Summary

A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).

Clinical Trial Description

A phase 2, randomized, double-blind, placebo-controlled clinical study of Nexvax2, in adults subjects with confirmed CeD who have been following a gluten free diet for at least 12 consecutive months prior to screening. This study will evaluate efficacy of Nexvax2 administered subcutaneously. The study plan consists of 3 periods: a screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week post-treatment observational follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03644069
Study type Interventional
Source ImmusanT, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 6, 2018
Completion date September 2019
View Details
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