A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
← catalyst calendarNCT06241118 · readout in 407 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
636estimated
Sites
150
Countries
Argentina, Australia, Brazil +20
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 | 2024-02-29 | actual | When the study began enrolling |
| Primary completion | 2027-09-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-09-29 | estimated | The whole study's end, after follow-up |
| First posted | 2024-02-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-02 | 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
- Drug: Topical corticosteroids
- Drug: Topical tacrolimus or pimecrolimus
Primary outcomes
what the primary-completion date above is the date OFEU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36
measured Week 36
EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI75) at Week 36
measured Week 36
US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36
measured Week 36
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