TEVA Study - Wesley Research Institute
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A Single-Dose Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Characterise the Safety and Tolerability of TEV-53408 Administered Subcutaneously in Adults with Coeliac DiseaseĀ 

Research Objectives

Status

Current

Recruitment

Closed

Total participants required

20

Study location

Wesley Research Institute

Study type

Industry Sponsored

Patient group

Coeliac Disease

About this clinical trial

The aim of this research study is to find out if a single injection of the research medicine, called TEV-53408, is safe and well-tolerated in adults with coeliac disease compared to a placebo injection. Ā 

A placebo looks very similar to the research medicine but does not contain any active medicine. Researchers use a placebo to see if a research medicine works better or is safer than not taking anything at all.Ā 

TEVA

Eligibility

  • Be between 18 and 70 years oldĀ 
  • Have a diagnosis of coeliac disease with intestinal biopsyĀ 
  • Have symptoms of coeliac disease when exposed to glutenĀ 
  • Be on (or trying to be on) a gluten-free diet with no to moderate symptomsĀ 
  • Have a positive HLA DQ2 or HLA DQ8 testĀ 
  • Received of all regionally required vaccinations recommended for age and concurrent medical conditions and/or agrees to receive prior to participation in the study (if able)Ā 

Lead investigator

  • Dr James Daveson

Experienced investigator

  • Dr Jennifer Schafer

Clinical trial coordinators

  • Chris Henderson
  • Leah Hingston

This clinical trial is now closed for recruitment

If you would like more information about this trial, please complete the contact form below.

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