A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
← catalyst calendarSponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
229actual
Sites
118
Countries
Argentina, Australia, Belgium +18
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-29 | actual | When the study began enrolling |
| Primary completion | 2026-08-05 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-04-10 | estimated | The whole study's end, after follow-up |
| First posted | 2024-08-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-25 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Coeliac Disease
- Celiac Disease
Interventions
- Drug: Amlitelimab — also filed as SAR445229
- Drug: Placebo
- Dietary supplement: SIGE
- Dietary supplement: Gluten-free product (GFP)
Primary outcome
what the primary-completion date above is the date OFChange in Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28
measured Baseline to Week 28
Permalink · SNY's whole pipeline · Catalyst calendar · Every registered study · What changed