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Study on the Effects of KAN-101 and Sodium Chloride in Adults with Celiac Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying celiac disease, a condition where the immune system reacts to gluten, a protein found in wheat, barley, and rye, causing damage to the small intestine. The study will evaluate a new treatment called KAN-101, which is being tested to see if it can help reduce the changes in the small intestine caused by gluten in people with celiac disease. Participants in the study will receive either KAN-101 or a placebo, which is a substance with no active medication, to compare the effects.

The purpose of the study is to assess how well KAN-101 can protect the small intestine from damage when gluten is introduced. This will be done by looking at changes in the structure of the small intestine through a procedure called esophagogastroduodenoscopy, which involves using a small camera to take a look inside the digestive tract. The study will also monitor the safety and tolerability of KAN-101 by checking for any side effects and measuring the levels of the drug in the blood.

Participants will be involved in the study for a period of time, during which they will undergo a gluten challenge, meaning they will consume gluten to see how their body responds with and without the treatment. The study will last for a few weeks, and participants will have regular check-ups to monitor their health and the effects of the treatment. The goal is to find out if KAN-101 can be a safe and effective treatment option for people with celiac disease.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and ensuring a diagnosis of celiac disease.
Eligibility criteria include being between 18 to 70 years old, having a documented diagnosis of celiac disease, and following a gluten-free diet for at least 12 months.
Step 2
Baseline evaluation
A baseline evaluation is performed, which involves an esophagogastroduodenoscopy (EGD) with biopsy to measure the villus-height:crypt depth (Vh:Cd) ratio in the intestine.
This step establishes a baseline for comparison after the gluten challenge.
Step 3
Gluten challenge
Participants undergo a 2-week gluten challenge (GC) where gluten is reintroduced into the diet.
The purpose is to assess the body's response to gluten and the effect of the study medication, KAN-101.
Step 4
Medication administration
During the study, participants receive either the study medication, KAN-101, or a placebo. The medication is administered as a solution for infusion.
The dosage and frequency are determined by the study protocol, and participants are monitored for any side effects.
Step 5
Follow-up evaluation
After the gluten challenge, a follow-up EGD with biopsy is conducted to reassess the Vh:Cd ratio.
This evaluation helps determine the efficacy of KAN-101 in reducing gluten-induced changes in the intestine.
Step 6
Monitoring and data collection
Throughout the study, participants are monitored for any adverse effects and changes in health status.
Blood samples are collected to measure levels of interleukin-2 (IL-2) and other markers, as well as to check for the presence of anti-drug antibodies.
Step 7
Study completion
Upon completion of the study, participants undergo a final assessment to evaluate overall health and any long-term effects of the medication.
The study aims to conclude by December 2024, with all data collected and analyzed to determine the safety and efficacy of KAN-101.

Who can join the trial?

6 criteria

Adults aged 18 to 70 years can participate.
Must have a previously documented diagnosis of celiac disease. This means having positive blood tests for celiac disease (like tissue transglutaminase IgA antibody or DGP IgG) and a specific type of intestinal damage called villous atrophy.
Must have a specific genetic type called HLA-DQ2.5. This involves certain genes that are common in people with celiac disease.
During screening, blood tests for transglutaminase IgA and DGP-IgA/IgG should be negative or only weakly positive.
Must have been on a gluten-free diet for at least 12 months before joining the study, as reported by the participant.
An intestinal biopsy during screening must show a Vh:Cd ratio of 2.3 or higher. This is a measure of the health of the small intestine.

Who cannot join the trial?

5 criteria

Individuals who do not have celiac disease cannot participate. Celiac disease is a condition where eating gluten causes harm to the small intestine.
Participants must be within the specified age range, which is not detailed here.
Both males and females can participate, but certain vulnerable populations may be excluded.
Participants must not have any other medical conditions that could interfere with the study.
Individuals who are unable to follow the study procedures or requirements will be excluded.

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Verified sites

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Albert Schweitzer Ziekenhuis
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Dordrecht, The Netherlands
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Verified
Cracow, Poland
Clinical Research Services Turku CRST Oy
Verified
Turku, Finland

Trial locations

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Investigated drugs

KAN-101 is a medication being studied for its potential to help people with celiac disease. The trial is looking at how well KAN-101 can reduce the damage caused by gluten in the small intestine. This is measured by looking at changes in the structure of the intestine, specifically the ratio of the height of the villi (tiny finger-like projections) to the depth of the crypts (small pits between the villi). The goal is to see if KAN-101 can protect the intestine from gluten-related harm.

What is already known about the treatment

KAN-101 – KAN-101 is administered intravenously and is currently being studied in clinical trials for its potential use in treating celiac disease. It is in the experimental phase, with ongoing research to evaluate its effectiveness and safety. The main therapeutic indication for KAN-101 is to help manage celiac disease by reducing the harmful effects of gluten on the small intestine. At the molecular level, KAN-101 works by modulating the immune response to gluten, aiming to prevent the immune system from attacking the intestinal lining. It is classified as an immunomodulatory agent, focusing on altering immune system activity to achieve its therapeutic effects.

Investigated diseases

Celiac Disease – Celiac disease is an autoimmune disorder where the ingestion of gluten leads to damage in the small intestine. When people with celiac disease eat gluten, their immune system responds by attacking the small intestine, specifically damaging the villi, which are small fingerlike projections that line the intestine. This damage impairs nutrient absorption, leading to various symptoms such as diarrhea, bloating, and fatigue. Over time, the continuous damage can lead to more severe health problems, including malnutrition and other autoimmune disorders. The disease can manifest at any age and is often hereditary, meaning it runs in families. Managing the disease involves avoiding gluten, which is found in wheat, barley, and rye.