NCT02528799

Safety and Tolerability of Nexvax2 in Subjects With Celiac Disease

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: ImmusanT, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
BIOLOGICAL	Nexvax2	Nexvax2 intra-dermal injections twice weekly
BIOLOGICAL	Nexvax2 placebo	Sodium chloride 0.9% intra-dermal injections twice weekly

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-01-06
• Completion: 2017-01-06
• First posted: 2015-08-19
• Last updated: 2018-12-24

Locations

4 sites across 2 countries: Australia, New Zealand