204 Participants Needed

Amlitelimab for Celiac Disease

Recruiting at 131 trial locations
TT
Overseen ByTrial Transparency email recommended (Toll free for US & Canada)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.

How does the drug Amlitelimab differ from other treatments for celiac disease?

Amlitelimab is a novel drug being studied for celiac disease, which is currently managed primarily through a strict gluten-free diet. Unlike the dietary approach, Amlitelimab may offer a pharmacological option, potentially targeting the immune response involved in celiac disease, although specific details about its mechanism in this condition are not provided in the available research.12345

What is the purpose of this trial?

This is a Phase 2a/b, randomized, double-blind, placebo-controlled, parallel-group, 6-arm study to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease (NRCD) who are on a gluten free diet (GFD) with and without simulated inadvertent gluten exposure (SIGE).The primary purpose of this study is to demonstrate the efficacy of subcutaneous (SC) amlitelimab in male and female participants (aged 18 to 75 years, inclusive) with NRCD. 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 crypt depth (Vh:Cd) ratio. The effect of amlitelimab on participant-reported celiac signs and symptoms along with the safety, tolerability, and pharmacokinetics of amlitelimab will also be studied.Study details include:The study duration will be up to 48 weeks (including a 16-week safety follow-up period) with 10 visits for participants who opt not to enter the optional long-term extension.The study duration will be up to 172 weeks (including an 8-week safety follow-up period) with 22 visits for participants who enter the optional long-term extension.The double-blind placebo-controlled treatment duration will be up to 28 weeks.

Eligibility Criteria

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.
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Timeline

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

Treatment Details

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.
Participant Groups
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Amlitelimab dose 3 + GFPExperimental Treatment2 Interventions
Amlitelimab SC as per protocol + GFP
Group II: Amlitelimab dose 2 + GFPExperimental Treatment2 Interventions
Amlitelimab SC as per protocol + GFP
Group III: Amlitelimab dose 1 + SIGEExperimental Treatment2 Interventions
Amlitelimab SC as per protocol + SIGE
Group IV: Amlitelimab dose 1 + Gluten-free product (GFP)Experimental Treatment2 Interventions
Amlitelimab SC as per protocol + GFP
Group V: Placebo + GFPPlacebo Group2 Interventions
Placebo SC as per protocol + GFP
Group VI: Placebo + SIGEPlacebo Group2 Interventions
Placebo SC as per protocol + SIGE

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials
2,246
Recruited
4,085,000+
Paul Hudson profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

Christopher Corsico

Sanofi

Chief Medical Officer

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

Findings from Research

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.
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]
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.
Celiac Disease Management in the United Kingdom Specialist Pediatric Gastroenterology Centers-A Service Survey.Paul, SP., Balakumar, V., Gillett, PM.[2023]
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.
Celiac disease in children.Garnier-Lengliné, H., Cerf-Bensussan, N., Ruemmele, FM.[2015]

References

Assessment of European Society of Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) guidelines in an Australian paediatric population. [2021]
Celiac Disease Management in the United Kingdom Specialist Pediatric Gastroenterology Centers-A Service Survey. [2023]
Celiac disease in children. [2015]
[Celiac disease associated with Helicobacter pylori infection]. [2020]
Human leukocyte antigen-DQ2 homozygosity and the development of refractory celiac disease and enteropathy-associated T-cell lymphoma. [2011]
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