Safety and Tolerability of Nexvax2 in Subjects With Celiac Disease
NCT02528799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2018-12-24
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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