A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
1,541actual
Sites
324
Countries
Argentina, Australia, Brazil +24
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 | 2024-05-08 | actual | When the study began enrolling |
| Primary completion | 2026-06-10 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-03-17 | estimated | The whole study's end, after follow-up |
| First posted | 2024-05-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Dermatitis Atopic
Interventions
- Drug: Amlitelimab — also filed as SAR445229
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFUS and US reference countries: Proportion of participants who are responders AND maintained vIGA-AD ≤2 without experiencing relapse among participants who were responders at baseline of ESTUARY
measured Week 24
EU, EU Reference Countries, and Japan: Proportion of participants who maintain treatment response in ESTUARY without experiencing relapse
measured Week 48
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