NCT06557772

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

A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Subcutaneous Amlitelimab in Adult Patients With Nonresponsive Celiac Disease as an Adjunct to a Gluten-free Diet

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coeliac Disease
• Celiac Disease

Interventions

Type	Name	Description
DRUG	Amlitelimab	Pharmaceutical form: Injection solution Route of administration: SC injection
DRUG	Placebo	Pharmaceutical form: Injection solution Route of administration: SC injection
DIETARY_SUPPLEMENT	SIGE	Pharmaceutical form: Capsule Route of administration: Oral
DIETARY_SUPPLEMENT	Gluten-free product (GFP)	Pharmaceutical form: Capsule Route of administration: Oral

Timeline

• Start date: 2024-08-29
• Primary completion: 2026-08-05
• Completion: 2029-04-10
• First posted: 2024-08-16
• Last updated: 2026-02-25

Locations

118 sites across 21 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, Finland, France, Germany, Greece, Israel, Italy, Netherlands, Poland, Slovakia, Spain, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study