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Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

NCT03543540 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-09-20

No results posted yet for this study

Summary

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

Conditions

  • Celiac Disease
  • Intestinal Disease
  • Malabsorption Syndromes
  • Gastrointestinal Disease
  • Digestive System Diseases
  • Metabolic Disease
  • Coeliac Disease
  • Gluten Sensitivity

Interventions

BIOLOGICAL

Nexvax2

Nexvax2 injections: 14 in total at twice weekly intervals

BIOLOGICAL

Placebo

Placebo injections: 14 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
2018-05-01
Primary Completion
2018-09-10
Completion
2018-09-10
FDA Drug
Yes

Countries

  • Australia

Study Locations

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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 NCT03543540 on ClinicalTrials.gov