Ongoing Clinical Trials for Coeliac Disease
This article provides information about 3 ongoing clinical trials investigating new treatments for coeliac disease (also known as celiac disease). These studies are testing medications that may help people who continue to experience symptoms despite following a gluten-free diet, or who wish to better manage their condition.
Clinical trial locations
- Austria
- Belgium
- Croatia
- Czechia
- Finland
- France
- Germany
- Greece
- Ireland
- Italy
- Netherlands
- Norway
- Poland
- Romania
- Slovakia
- Spain
- Sweden
Study on the Effects of Amlitelimab for Adults with Non-Responsive Celiac Disease
This study is testing amlitelimab, a medication given as an injection under the skin, in adults who have coeliac disease that does not improve even when they follow a gluten-free diet. This condition is known as non-responsive coeliac disease.
Who can participate: Adults between 18 and 75 years old who have been diagnosed with coeliac disease and have been following a gluten-free diet for at least 12 months. Participants must understand what a gluten-free diet involves and be willing to continue it during the study. They should have at least one moderate or severe digestive symptom, such as diarrhea, stomach pain, bloating, or nausea, on at least three days per week, which is believed to be related to gluten exposure. Participants must be willing to undergo two procedures where a thin tube with a camera is used to examine the upper digestive system and take tissue samples from the small intestine.
Who cannot participate: People who do not have non-responsive coeliac disease, those not following a gluten-free diet, pregnant or breastfeeding women, and individuals with other medical conditions that might interfere with the study. People participating in other clinical trials at the same time or those with a history of severe allergic reactions are also excluded.
What the study involves: The trial lasts for 28 weeks, during which participants receive either amlitelimab or a placebo. Neither the participants nor the researchers know who receives which treatment. The main goal is to see if amlitelimab can improve the condition of the intestinal lining by measuring changes in the structure of the small intestine. Throughout the study, participants undergo regular health assessments to monitor symptoms, side effects, and the levels of medication in their blood.
Investigational drug: Amlitelimab works by modulating the immune response, potentially reducing inflammation in the gut and protecting the intestines from gluten-induced damage.
Study on the Effects of KAN-101 and Sodium Chloride in Adults with Celiac Disease
This trial is evaluating KAN-101, a medication given through an infusion into the vein, to see if it can help protect the small intestine from damage when gluten is consumed by people with coeliac disease.
Who can participate: Adults aged 18 to 70 who have a documented diagnosis of coeliac disease, confirmed by positive blood tests and a specific type of intestinal damage called villous atrophy. Participants must have a specific genetic type called HLA-DQ2.5 and have been following a gluten-free diet for at least 12 months. During screening, certain blood tests should be negative or only weakly positive, and an intestinal biopsy must show a healthy small intestine with a villus height to crypt depth ratio of 2.3 or higher.
Who cannot participate: Individuals who do not have coeliac disease, those with other medical conditions that could interfere with the study, and people unable to follow study procedures.
What the study involves: After confirming eligibility and performing a baseline intestinal biopsy, participants undergo a two-week gluten challenge where gluten is reintroduced into the diet. During this time, participants receive either KAN-101 or a placebo. After the gluten challenge, another biopsy is performed to assess any changes in the intestinal structure. The study monitors for side effects and measures various markers in the blood throughout the process.
Investigational drug: KAN-101 is an immunomodulatory agent that works by altering immune system activity to reduce the harmful effects of gluten on the small intestine.
Study on ZED1227 for Improving Symptoms in Celiac Disease Patients on a Gluten-Free Diet
This study is investigating ZED1227, taken as a hard capsule by mouth, in people with coeliac disease who continue to have symptoms despite following a gluten-free diet.
Who can participate: Adults aged 18 to 80 who have a confirmed diagnosis of coeliac disease from at least 12 months ago and have been following a gluten-free diet during that time. Participants must have a specific genetic marker called HLA-DQ linked to coeliac disease and must have experienced at least one moderate or severe stomach-related symptom, such as diarrhea, stomach pain, bloating, or nausea. A recent biopsy must show a specific measurement indicating intestinal damage, and there should be no current infection with Helicobacter pylori bacteria. Participants must have a body mass index between 17.0 and 35 kg/m² and be willing to continue their usual eating habits. Women under 60 need to have a negative pregnancy test and use effective birth control during the study.
Who cannot participate: People with other serious health conditions, pregnant or breastfeeding women, those with a history of severe allergic reactions to study medications, individuals using certain medications that might interfere with results, those who participated in another recent clinical trial, people with a history of drug or alcohol abuse, and those with various conditions affecting the immune system, heart, blood pressure, liver, kidneys, blood, lungs, stomach, intestines, neurological or mental health, infections, autoimmune diseases, metabolic disorders, or genetic disorders.
What the study involves: The trial lasts 15 weeks. After an initial assessment and two baseline visits where symptoms are recorded, participants are randomly assigned to receive either ZED1227 or a placebo. Throughout the trial, symptoms such as diarrhea, abdominal pain, bloating, and nausea are monitored using a symptom diary. At the end of the treatment phase, a final biopsy is performed to evaluate changes in the small intestine and measure inflammation levels.
Investigational drug: ZED1227 is an enzyme inhibitor that works by blocking the enzyme transglutaminase 2, which plays a role in the inflammatory response triggered by gluten. This may help alleviate symptoms and improve the health of the intestinal lining.
Summary
Three ongoing clinical trials are currently exploring new treatment options for coeliac disease across multiple European countries. The studies are concentrated particularly in Finland, Germany, Poland, and Sweden, which each host multiple trials. All three studies focus on people who continue to experience symptoms despite following a gluten-free diet, representing an important unmet medical need.
The trials are testing three different investigational medications with distinct mechanisms of action. Amlitelimab and KAN-101 are both immunomodulatory agents that work by altering the immune system’s response to gluten, while ZED1227 is an enzyme inhibitor that blocks a specific enzyme involved in the inflammatory process. Two medications are given by injection or infusion, while ZED1227 is taken orally as a capsule.
Each study requires participants to have a confirmed diagnosis of coeliac disease and to have been following a gluten-free diet for at least 12 months. The studies use different approaches to assess treatment effectiveness, including examining changes in the intestinal lining, measuring symptom improvements, and evaluating responses to controlled gluten challenges. These trials aim to provide valuable information about potential new treatment options for people with coeliac disease who do not fully respond to a gluten-free diet alone.
