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Study on the Effects of Amlitelimab for Adults with Non-Responsive 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 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.

The research process

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

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history of celiac disease, and adherence to a gluten-free diet for at least 12 months.

    Participants must demonstrate an understanding of a gluten-free diet and agree to maintain it throughout the study.

    Participants undergo a screening process to ensure they have at least one moderate or severe gastrointestinal symptom related to gluten exposure.

  2. Step 2

    Baseline evaluation

    A baseline esophagogastroduodenoscopy (EGD) is performed to collect duodenal biopsies. This procedure helps assess the condition of the intestinal lining before treatment begins.

  3. Step 3

    Randomization and treatment

    Participants are randomly assigned to receive either amlitelimab or a placebo. The treatment is administered as a subcutaneous injection using a pre-filled syringe.

    The study is double-blind, meaning neither the participants nor the researchers know who receives the actual medication or the placebo.

  4. Step 4

    Treatment period

    The treatment period lasts for 28 weeks. During this time, participants receive regular injections according to the study schedule.

    Participants continue to follow their gluten-free diet and report any symptoms or side effects experienced during the study.

  5. Step 5

    Follow-up assessments

    Throughout the study, participants undergo regular assessments to monitor their health and the effects of the treatment.

    These assessments include measuring changes in gastrointestinal symptoms and checking for any adverse events or abnormalities in vital signs and laboratory tests.

  6. Step 6

    Final evaluation

    At the end of the 28-week treatment period, a final esophagogastroduodenoscopy (EGD) is performed to evaluate changes in the intestinal lining.

    The primary goal is to assess the change in the villus height to crypt depth ratio, which indicates the health of the intestinal mucosa.

  7. Step 7

    Study completion

    After completing the study, participants may be asked to provide feedback on their experience and any long-term effects observed.

    The study aims to gather data on the efficacy and safety of amlitelimab in treating non-responsive celiac disease.

Who can join the trial?

7 criteria

  • Participants must be between 18 and 75 years old at the time they agree to join the study.
  • Participants must have been diagnosed with **celiac disease** by a doctor, with proof from a past biopsy (a small tissue sample taken for testing) confirmed by medical records or a doctor's statement.
  • Participants must have tried to follow a **gluten-free diet (GFD)** for at least 12 months in a row and must be willing to continue their current diet during the study.
  • Participants must understand what a **gluten-free diet (GFD)** is, as checked by the study doctor.
  • Participants must be willing to go through all the tests in the study plan, including two **esophagogastroduodenoscopies** (a procedure where a thin tube with a camera is used to look at the upper digestive system) with **duodenal biopsies** (taking small samples from the small intestine).
  • Participants must have completed the **CDSD** with at least 75% compliance from the start of the study until they are randomly assigned to a group.
  • During the initial screening, participants must have at least one digestive symptom like diarrhea, stomach pain, bloating, or nausea that is moderate or more severe, on at least 3 out of any 7 consecutive days, which the study doctor believes is related to gluten exposure. The symptom can change, but it must be moderate or more severe on three or more days. Participants must meet these symptom requirements to have the initial **esophagogastroduodenoscopy (EGD)**.

Who cannot join the trial?

8 criteria

  • Individuals who do not have non-responsive celiac disease (NRCD). This means the person must have celiac disease that does not improve with a gluten-free diet.
  • Individuals who are not following a gluten-free diet or are not exposed to gluten as part of the study conditions.
  • Individuals who are not within the specified age range for the study. The study is open to certain age groups only.
  • Individuals who are not willing or able to follow the study procedures and requirements.
  • Individuals who have other medical conditions that might interfere with the study or its results.
  • Individuals who are pregnant or breastfeeding, as the study may not be safe for them.
  • Individuals who are participating in another clinical trial at the same time, as this could affect the study results.
  • Individuals who have a history of severe allergic reactions or other serious health issues that could pose a risk during the study.
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Investigated drugs

Amlitelimab is a medication being studied for its potential to help people with non-responsive celiac disease. This condition occurs when individuals with celiac disease do not fully respond to a gluten-free diet. Amlitelimab is given as an injection under the skin and is being tested to see if it can improve the health of the intestines in these patients, either when they are on a strict gluten-free diet or when they are exposed to some gluten.

What is already known about the treatment

Amlitelimab – Amlitelimab is administered through subcutaneous injection and is currently being studied in clinical trials for its potential use in treating non-responsive celiac disease. This medication is in the investigational stage and is not yet widely recognized in medical literature as a standard treatment. It is primarily being evaluated for its ability to improve or reduce gluten-induced changes in the intestinal lining of patients who do not respond to a gluten-free diet. Amlitelimab works by modulating the immune response, potentially reducing inflammation in the gut. It is classified as an immunomodulatory agent.

Investigated diseases

Coeliac disease – Coeliac disease is an autoimmune disorder where the ingestion of gluten leads to damage in the small intestine. When people with this condition eat gluten, their immune system responds by attacking the small intestine, specifically damaging the villi, which are small finger-like projections that line the intestine. This damage impairs nutrient absorption, leading to various gastrointestinal symptoms such as diarrhea, bloating, and abdominal pain. Over time, the continuous damage can lead to malnutrition and other health issues. The disease can also cause symptoms outside the digestive system, including fatigue and skin rashes. It is a chronic condition that requires lifelong management through dietary changes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511213-38-00Protocol codeDRI17963Estimated enrolment816 patientsSponsorSanofi-Aventis Recherche & Developpement

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