Sanofi's Amlitelimab Shines in Phase 3 Atopic Dermatitis Trials

Sanofi has announced promising results for amlitelimab, a treatment for moderate-to-severe atopic dermatitis (AD), following two global Phase 3 studies—SHORE and COAST 2.

The information demonstrates that amlitelimab is effective to treat AD and possesses a positive side of the safety profile in adult patients (12 years and older).

OX40-ligand (OX40L) Amlitelimab was a fully human monoclonal antibody that was tolerated in both trials. The results, together with the research of the COAST 1 study, point to the fact that it has the potential to normalize the immune system without depleting T-cells, which results in a significant skin clearance and decrease the severity of the disease.

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Houman Ashrafian, Executive VP of R&D at Sanofi, stated, "These results validate amlitelimab’s novel mechanism of action and reinforce our confidence in its potential to deliver progressive efficacy through Week 52."

The two Phase 3 trials achieved both primary endpoints, which included a validated investigator global assessment scale (vIGA-AD) score of 0 or 1, which means clear or nearly clear skin. Nevertheless, in certain areas such as the EU the COAST 2 trial failed to achieve secondary endpoints.

In the meantime, the current ATLANTIS Phase 2 trial demonstrated that amlitelimab has increased skin clearance until Week 52. These successful outcomes precondition the submissions on a global level, which will be possible in the second half of 2026.