This clinical trial is focused on studying celiac disease, a condition where the body’s immune system reacts to gluten, a protein found in wheat, barley, and rye. The study is investigating a treatment called amlitelimab, which is given as a solution for injection under the skin. The purpose of the study is to evaluate how effective and safe amlitelimab is in helping adults with non-responsive celiac disease, which means their symptoms do not improve even when they follow a gluten-free diet.
Participants in the study will receive either amlitelimab or a placebo, which looks like the treatment but does not contain the active medicine. The study will last for several months, during which participants will continue their gluten-free diet. Some participants may also be exposed to gluten to see how the treatment works under different conditions. Throughout the study, participants will have regular check-ups and tests to monitor their health and any changes in their symptoms.
The main goal is to see if amlitelimab can improve the condition of the intestinal lining, which is often damaged in people with celiac disease. The study will also track any side effects and measure the levels of amlitelimab in the blood. This research aims to provide new insights into managing celiac disease for those who do not respond well to a gluten-free diet alone.
Belgium 
Czechia 
Finland 
France 
Germany 
Greece 
Italy 
Poland 
Slovakia 
Spain 
Sweden 
The Netherlands 
