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A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease

Testing amlitelimab's safety and effectiveness for celiac disease relief.

Recruiting
18-75 years
All
Phase 2

This study tests a drug called **amlitelimab** on adults with celiac disease who don't get better on a gluten-free diet. Celiac disease is when the body can't handle gluten, a protein in wheat and other grains. Amlitelimab is given through a shot under the skin, and the study wants to see if it helps the gut heal and reduces symptoms like stomach pain or bloating.

Participants will be randomly given either amlitelimab or a placebo (a fake treatment) without knowing which one they receive. The main goal is to check if amlitelimab works better than the placebo by looking at gut health and symptoms. Safety and how the body handles the drug will also be studied.

  • The study lasts up to 48 weeks with 10 visits, or up to 172 weeks with 22 visits if you join the optional long-term part.
  • Participants must be 18-75 years old and willing to follow their current gluten-free diet during the study.
  • Participants will have 2 endoscopies to check their gut health.

Not everyone can join. People with other serious gut problems or certain health conditions can't participate.

Study details
    Coeliac Disease
    Celiac Disease

NCT06557772

Sanofi

23 August 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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