Amlitelimab for Celiac Disease

Recruiting at 187 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must not be taking: NSAIDs, Immunosuppressants, Corticosteroids, others

Disqualifiers: Refractory celiac, Inflammatory GI, Autoimmune, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

Duration: 28 weeks

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests amlitelimab, a medication designed to help individuals with non-responsive celiac disease (NRCD) who continue to experience symptoms despite adhering to a gluten-free diet. Researchers aim to determine if amlitelimab can reduce symptoms and improve gut health compared to a placebo. Participants should have celiac disease that does not respond well to a gluten-free diet and experience frequent symptoms such as diarrhea or abdominal pain. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially improve their symptoms.

Will I have to stop taking my current medications?

The trial requires stopping certain medications, such as those known to cause villus abnormalities and ongoing use of systemic immunosuppressants or corticosteroids. If you're taking any of these, you may need to stop them before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that amlitelimab is generally well-tolerated. Studies have found no new safety concerns, indicating it is safe for humans.

In another study, amlitelimab met all its safety goals, with most participants not experiencing serious side effects. While no treatment is completely risk-free, evidence suggests that amlitelimab is a promising option.

The study under consideration is part of ongoing research to confirm these findings. Always consult your doctor if you have concerns or questions about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for celiac disease?

Amlitelimab is unique because it targets the OX40-Ligand, a pathway involved in immune responses, which is different from most current treatments for celiac disease that focus on strict dietary restrictions like gluten-free diets. This new mechanism of action offers the potential to modulate the immune system more directly, addressing the root cause of the immune response in celiac disease. Researchers are excited about Amlitelimab because it could offer a therapeutic option that doesn't rely solely on dietary management, potentially improving quality of life for patients by reducing immune reactions to gluten.

What evidence suggests that this trial's treatments could be effective for non-responsive celiac disease?

Research has shown that amlitelimab could address issues related to celiac disease. In studies for conditions like atopic dermatitis, amlitelimab met its main goals, indicating it can effectively reduce inflammation. This is crucial for celiac disease, as gut inflammation is a significant problem. In this trial, participants will receive varying doses of amlitelimab combined with either a gluten-free product (GFP) or SIGE, or a placebo with GFP or SIGE. The drug aims to heal the intestines and mitigate the effects of accidental gluten consumption. Early results suggest that amlitelimab might benefit those with celiac disease who do not respond well to a gluten-free diet alone. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 18-75 with non-responsive celiac disease (NRCD) who have tried a gluten-free diet for at least a year can join. They must be willing to undergo tests including biopsies and show moderate or severe gastrointestinal symptoms related to gluten exposure.

Inclusion Criteria

I am willing to undergo all required tests, including 2 upper GI endoscopies with biopsies.

I understand what a gluten-free diet involves.

I followed through with my previous study tasks at least 75% of the time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous amlitelimab or placebo for up to 28 weeks in a double-blind, placebo-controlled setting

28 weeks

10 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

2 visits

Long-term extension (optional)

Participants may opt into continuation of treatment long-term

124 weeks

12 visits

What Are the Treatments Tested in This Trial?

Interventions

• Amlitelimab

Trial Overview The trial is testing Amlitelimab, an injectable medication, against a placebo in participants with NRCD. It aims to see if the drug improves intestinal damage caused by gluten and reduces celiac symptoms compared to no treatment.

How Is the Trial Designed?

Group I: Amlitelimab dose 3 + GFP Experimental Treatment 2 Interventions

Amlitelimab SC as per protocol + GFP

Group II: Amlitelimab dose 2 + GFP Experimental Treatment 2 Interventions

Amlitelimab SC as per protocol + GFP

Group III: Amlitelimab dose 1 + SIGE Experimental Treatment 2 Interventions

Amlitelimab SC as per protocol + SIGE

Group IV: Amlitelimab dose 1 + Gluten-free product (GFP) Experimental Treatment 2 Interventions

Amlitelimab SC as per protocol + GFP

Group V: Placebo + GFP Placebo Group 2 Interventions

Placebo SC as per protocol + GFP

Group VI: Placebo + SIGE Placebo Group 2 Interventions

Placebo SC as per protocol + SIGE

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

Celiac disease is an autoimmune condition triggered by gluten in genetically predisposed individuals, with a prevalence estimated between 1 in 100 and 1 in 400, and it can present either symptomatically or asymptomatically.

The only effective treatment for celiac disease is a strict gluten-free diet, which leads to clinical remission within weeks, although full recovery of the small bowel may take months to years, helping to prevent serious long-term complications like osteoporosis and cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Celiac disease in children. Garnier-Lengliné, H., Cerf-Bensussan, N., Ruemmele, FM.[2015]

A 3-year-old girl with celiac disease initially improved on a gluten-free diet but later experienced abdominal pain and anorexia after 2 years.

The symptoms were linked to Helicobacter pylori gastritis, and after successful treatment to eradicate the bacteria, her symptoms resolved, highlighting the importance of monitoring for other gastrointestinal issues in celiac disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Celiac disease associated with Helicobacter pylori infection]. Cârdei, E., Moraru, D., Trandafir, L., et al.[2020]

In a study of 209 children suspected of having coeliac disease (CD), 61.5% were diagnosed with CD, and 29% could have avoided biopsy using updated ESPGHAN guidelines based on high levels of specific antibodies.

The study found that testing for IgA tissue transglutaminase (aTTG) and IgG antibodies to deamidated gliadin (DGP) provided 100% specificity and positive predictive value for CD, suggesting that HLA typing and endomysial antibodies (EMA) may not be necessary for diagnosis in patients with high aTTG levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of European Society of Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) guidelines in an Australian paediatric population. Thompson, G., Grover, Z., Loh, R., et al.[2021]

HLA-DQ2 homozygosity is significantly associated with severe complications in celiac disease, such as refractory celiac disease type II (RCD II) and enteropathy-associated T-cell lymphomas (EATL), based on a study of 43 RCD I, 43 RCD II, and 30 EATL patients compared to controls.

Identifying patients with homozygous HLA-DQ2 early could help in recognizing those at higher risk for developing these serious complications, as 97.7% of RCD II and 96.6% of EATL patients had HLA-DQ2 compared to only 28.9% in healthy controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human leukocyte antigen-DQ2 homozygosity and the development of refractory celiac disease and enteropathy-associated T-cell lymphoma. Al-Toma, A., Goerres, MS., Meijer, JW., et al.[2011]

The majority of specialist pediatric gastroenterology centers in the UK (28 out of 29) have successfully implemented the no-biopsy pathway for diagnosing celiac disease in symptomatic children, aligning with the 2012 ESPGHAN guidelines.

Despite good adherence to the guidelines, there are notable variations in practices, such as the use of HLA-DQ2/DQ8 testing and the timing of gluten-free diet initiation, indicating a need for more standardized follow-up protocols and research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Celiac Disease Management in the United Kingdom Specialist Pediatric Gastroenterology Centers-A Service Survey. Paul, SP., Balakumar, V., Gillett, PM.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06557772

NCT06557772 | A Phase 2a/b Study of the Efficacy and ... The study will assess the effect of amlitelimab when compared to placebo on gluten induced changes in the intestinal mucosa as measured by the villous height to ...

2. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-09-04-05-00-00-3144170

Press Release: Sanofi's amlitelimab met all primary and ... Sanofi's amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic ...

3. trialx.com trialx.com/5-ongoing-breakthrough-clinical-trials-advancing-celiac-disease-research/

5 Ongoing Breakthrough Clinical Trials Advancing Celiac ... The drug aims to improve intestinal healing and reduce the impact of accidental gluten exposure. Why It Stands Out. This study targets a high- ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/SNY/pressreleases/34204427/sanofis-promising-study-on-amlitelimab-for-celiac-disease-a-potential-market-game-changer/

Sanofi's Promising Study on Amlitelimab for Celiac Disease Sanofi SA has launched a Phase 2a/b clinical study to evaluate the efficacy and safety of subcutaneous amlitelimab in adults with nonresponsive ...

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-of-amlitelimab-for-adults-with-non-responsive-celiac-disease/

Study on the Effects of Amlitelimab for Adults with Non- ... The purpose of the study is to evaluate how effective and safe amlitelimab is in helping adults with non-responsive celiac disease.

6. sanofi.com sanofi.com/assets/dotcom/pressreleases/2025/2025-09-04-05-00-00-3144170-en.pdf

Sanofi's amlitelimab met all primary and key secondary ... Amlitelimab was well-tolerated, with no new safety concerns identified in this study. “These positive first phase 3 results of amlitelimab ...

7. mayo.edu mayo.edu/research/clinical-trials/cls-20580371

A Phase 2a/b Study of the Efficacy and Safety ... The purpose of this study is to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease (NRCD) ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06557772?term=AREA%5BConditionSearch%5D(Celiac%20Disease)&rank=7

A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...