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Monoclonal Antibodies

Amlitelimab for Celiac Disease

Phase 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Participants must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
* Participants willing to undergo all assessments in the protocol, including 2 esophagogastroduodenoscopies with duodenal biopsies.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 28

Summary

This trial will test the effectiveness and safety of a drug called amlitelimab in adults with non-responsive celiac disease who are on a gluten-free diet. The study will compare amlit

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of Amlitelimab are not listed here, common risks may include injection site reactions, potential allergic responses, and other immune-related effects as it's being tested for safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I am willing to undergo all required tests, including 2 upper GI endoscopies with biopsies.
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I have followed a gluten-free diet for at least 12 months and will continue it during the study.
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I have celiac disease confirmed by a biopsy and my doctor's records.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28
Secondary study objectives
Change in Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) symptom severity score

Trial Design

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 Location

Who is running the clinical trial?

SanofiLead Sponsor
2,209 Previous Clinical Trials
4,039,562 Total Patients Enrolled
~136 spots leftby Aug 2026
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