Safety and Tolerability of Nexvax2 in Subjects With Celiac Disease

NCT02528799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-12-24

No results posted yet for this study

Summary

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

Conditions

Interventions

BIOLOGICAL

Nexvax2

Nexvax2 intra-dermal injections twice weekly

BIOLOGICAL

Nexvax2 placebo

Sodium chloride 0.9% intra-dermal injections twice weekly

Sponsors & Collaborators

  • ImmusanT, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert P. Anderson, MB ChB, PhD · ImmusanT, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-01-06
Completion
2017-01-06

Countries

  • Australia
  • New Zealand

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02528799 on ClinicalTrials.gov