Topas Therapeutics GmbH Study - Wesley Research Institute
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A double-blind, randomized, placebo-controlled, phase 2a study  to evaluate the safety, tolerability, and pharmacodynamic (PD) effects of two infusions of escalating doses of TPM502 in adults diagnosed with Coeliac Disease (CeD)

Research Objectives

Status

Current

Total participants required

42

Study location

Wesley Research Institute

Study Type

Industry Sponsored

About this clinical trial

The clinical study will focus on the treatment of Coeliac Disease, which is a chronic autoimmune disease that affects the small intestine. In autoimmune diseases, there is a mix up in the body’s defence system: instead of protecting the body, the defence system recognizes its own cells or tissues as strangers and possibly harmful, and fights them. When ingesting food containing gluten, such as wheat, barley or rye, the small intestine of patients with coeliac disease reacts with a chronic inflammation response that can lead to a loss of the ability to absorb nutrients. Upon consumption of gluten-containing food, coeliac disease patients suffer from abnormal symptoms, that can in many cases be severe. This is because the body recognizes gluten as a substance that may be harmful and not as a simple nutrient. The investigational medicine TPM502 which you will receive in this study is supposed to teach your body not to react to gluten, and to treat it as any other nutrient, by restoring your immune system’s tolerance to gluten. TPM502 contains minuscule parts of gluten that are presented to the liver, an organ which is able to teach the rest of the body not to react to foreign substances.

 

To date, the only effective treatment is a life-long gluten-free diet, which is difficult to follow and does not always lead to the complete resolution of disease symptoms. This is the first time that TPM502 is being administered to humans. The purpose of the study is to determine how safe TPM502 is, and how your body absorbs TPM502. 

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Eligibility

  • Aged 18-70 years 
  • Biopsy-confirmed diagnosis of Coeliac Disease  
  • Human leukocyte antigen (HLA)-DQ2.5 positive AND HLA-DQ8 negative AND HLA-Q2.2 negative 
  • Gluten-free diet ≥ 6 months 
  • Body weight ≥ 50.0kg and a BMI ≥ 18.0 and ≤33.0 kg/m2

Additional information

A double-blind, randomized, placebo-controlled, phase 2a study  to evaluate the safety, tolerability, and pharmacodynamic (PD) effects of two infusions of escalating doses of TPM502 in adults diagnosed with Coeliac Disease (CeD)

Lead investigators

  • A/Prof James Daveson
  • Dr Jennifer Schafer

Register your interest

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

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You must be based in the Greater Brisbane region to be eligible for this study.
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Have you had a small bowel biopsy and/or blood test to confirm the diagnosis?(Required)
Have you been eating a strict gluten free diet for at least the last 6 months?(Required)
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Do you consent to be contacted about any current Coeliac Disease research projects?(Required)
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