New Phase 2 clinical trial tests non-responsive celiac disease treatment

The ASPIRION Trial is testing amlitelimab as a treatment for non-responsive celiac disease

By Kate Avery, Senior Director of Coalition & Patient Engagement

An ongoing Phase 2 clinical trial is testing a potential treatment, amlitelimab, for celiac disease that has already been studied in clinical trials for atopic dermatitis and is also currently being studied in additional inflammatory and autoimmune conditions (e.g., asthma, alopecia areata, and systemic sclerosis). The ASPIRION Trial is conducted by Sanofi, and clinical trial sites are located in the United States, Canada, Australia, Europe, Turkey, Israel, and South America.

Amlitelimab is a monoclonal antibody that is proposed to work in celiac disease by interrupting the immune response that occurs, specifically by blocking a molecule in the body called OX-40 Ligand (OX-40 Ligand normally plays a role in activating T cells, which is a driver of inflammation in celiac disease). In previous clinical trials for atopic dermatitis, amlitelimab was shown to be safe and efficacious in reducing inflammation caused by T-cells. T-cell inflammation also occurs in celiac disease. Studying potential treatments that have already been tested in clinical trials for other autoimmune conditions is one way to accelerate the development of a celiac disease treatment because these drugs have already been tested for safety, so they do not need to go through additional Phase 1 clinical trials again and can begin at Phase 2.

This Phase 2 trial is studying the efficacy and safety of amlitelimab in people with non-responsive celiac disease, who have been on the gluten-free diet for at least 12 months and continue to have symptoms and intestinal damage. Three different doses of amlitelimab are being tested to find the optimal dose for people with celiac disease. Trial participants will be assigned to receive either subcutaneous (below the skin) injections of amlitelimab or placebo. A placebo looks exactly like the treatment but does not contain any of the active drug. In addition, one-third of participants will receive capsules containing a small amount of gluten for up to 12 weeks during the trial, and the remaining two-thirds of participants will not be exposed to gluten during the trial. The amount of potential gluten exposure is equivalent to less than one bite of bread per day and is designed to mimic what a person with celiac disease might be inadvertently exposed to while dining out or through cross-contact.

Participation in the ASPIRION study will last for 48 weeks, with up to 10 visits to the study site. All participants will undergo two small intestinal endoscopies and biopsies during the trial, to see if and how well the drug protects the small intestine and to assess healing. Participants will also track their symptoms in a daily symptom diary. Safety and any potential side effects of the drug will also be monitored, which is always the case in all phases of clinical trials. All participants who complete the study will have the option to enter a Long-Term Extension, which provides treatment with amlitelimab for all participants (even those who were originally given placebo) for an additional 2.5 years while continuing to track safety and efficacy. No additional endoscopies or biopsies are required in the Long-Term Extension.

To be eligible to participate, you must be 18-75 years old, a US resident with biopsy-diagnosed celiac disease, and have followed the gluten-free diet for at least one year. To find out if you qualify, please visit the study website to learn more about the study and see if there is a site close to you.

Beyond Celiac is working with Sanofi to help raise awareness for this trial as part of our commitment to accelerating research. For more information about the ASPIRION study and to see if you qualify, visit this link. More information about the trial is also available at ClinicalTrials.gov.