MedTrace Logo

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

NCT03644069 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2019-03-19

No results posted yet for this study

Summary

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

Conditions

Interventions

BIOLOGICAL

Nexvax2

Nexvax2 subcutaenous (SQ) injections: 32 in total, at twice weekly intervals

BIOLOGICAL

Placebo

Placebo SQ injections: 32 in total, at twice weekly intervals

Sponsors & Collaborators

  • ImmusanT, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Anderson, PhD, FRACP · ImmusanT, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-08-06
Primary Completion
2019-09-30
Completion
2019-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03644069 on ClinicalTrials.gov