KAN101 - Wesley Research Institute
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This study will investigate the safety and tolerability of multiple intravenous (IV) doses of KAN-101 in patients with well-controlled Coeliac Disease. It is expected to act by reprogramming immune cells to become tolerant towards gluten.

Research Objectives

Status

Current

Recruitment

Open

Total participants required

104

Study location

Wesley Research Institute

Study type

Industry Sponsored

Patient group

Participants with well-controlled Coeliac Disease

About this clinical trial

Coeliac disease is digestive and autoimmune disorder that affects your small intestine. Coeliac disease can be triggered by a protein called gluten that is found in grains, like wheat, barley and rye. People with coeliac disease like you may experience symptoms like diarrhoea, bloating, abdominal pain, and other symptoms involved in multiple organs beyond the small intestine. Currently there is no drug that is available to treat coeliac disease. The only available option is following a strict gluten-free diet. This can be difficult for some patients with coeliac disease because of the uncertainty about which foods and medications contain gluten, and the cost of gluten free products.

The study drug (KAN-101) acts by reprogramming immune cells to become tolerant, or not react, specifically toward gluten. The drug is designed to not suppress the other parts of your immune system and only impact the cells that respond to gluten. This study will explore whether the study drug is effective in blocking the immune response to gluten and if it is safe for human-use.

Participants are in the study for up to 56 weeks which consists of 3 phases:

  1. Screening (4 weeks, includes upper gastrointestinal endoscopy and biopsy)
  2. Treatment (1 week, includes 3 single day infusions)
  3. Follow-up (51 weeks, includes 4 single day gluten challenges)

Participants will be required to visit the research site 10 times.

Trial registration information https://clinicaltrials.gov/study/NCT05574010.

KAN-101-02 Part C

Eligibility

  • Biopsy & blood test results providing diagnosis
  • HLA-DQ2.5 positive AND HLA-DQ8 negative
  • Gluten Free Diet > 12 months
  • Males & Females aged 18 – 70 years (incl)

Lead investigators

  • Dr James Daveson
  • Dr Jennifer Schafer

Clinical trial coordinators

  • Leah Hingston
  • Elise Matuzelski

Technical title

A phase 1b open-label/ phase 2 double-blind placebo-controlled study for pharmacodynamic activity, pharmacokinetics, safety and tolerability of kan-101 in patients with coeliac disease

Register your interest

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

Name(Required)
Participants to be located within Brisbane and surrounds
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Which if the following accurately describes you?(Required)

Do you have a Coeliac Disease diagnosis from a biopsy?(Required)
Do you have a Coeliac Disease diagnosis from a blood test?(Required)
Have you been on a gluten free diet for longer than 12 months?(Required)
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