Sanofi’s Amlitelimab Delivers Positive Phase 3 Data in Moderate-to-Severe Atopic Dermatitis

Sanofi announced positive results from two global Phase 3 trials of amlitelimab in adolescents and adults with moderate-to-severe atopic dermatitis (AD).

The studies, SHORE and COAST 2, build on previously reported positive COAST 1 data and strengthen the evidence base for amlitelimab’s potential.

Why amlitelimab is different?

Amlitelimab is a fully human monoclonal antibody that:

• Selectively blocks OX40-ligand (OX40L)
• Does not deplete T cells
• Aims to normalize immune signaling over time

This mechanism targets the early inflammatory phase of immune activation. Sanofi believes this approach may enable durable disease control with less frequent dosing.

Key takeaway from Phase 3 program

Across SHORE and COAST 2:

• Amlitelimab was well tolerated
• Safety was consistent with previous studies
• Both Q4W and Q12W dosing showed clinical activity

Sanofi plans global regulatory submissions in H2 2026.

SHORE study: combination therapy success

SHORE evaluated amlitelimab plus topical corticosteroids, with or without topical calcineurin inhibitors.

At Week 24, amlitelimab:

• Met all primary endpoints versus placebo
• Met all key secondary endpoints
• Showed benefit with both Q4W and Q12W dosing

Results were consistent across US and EU regulatory estimands.

COAST 2 study: monotherapy results

COAST 2 evaluated amlitelimab as monotherapy.

At Week 24:

• Primary endpoint was met for US and reference countries
• EU co-primary endpoints were not statistically significant
• Additional secondary endpoints showed nominal significance

Despite regional differences, clinical activity was observed with both dosing schedules.

Safety profile across studies

Most common treatment-emergent adverse events included:

• Nasopharyngitis
• Upper respiratory tract infection
• Atopic dermatitis flares

Rates of:

• Serious adverse events
• Treatment discontinuation

were similar between amlitelimab and placebo groups.

Long-term data: ATLANTIS Phase 2

A preliminary analysis of the open-label ATLANTIS study showed:

• Progressive improvement through Week 52
• Continued tolerability with Q4W dosing

Low rates of serious adverse events and discontinuations were reported.

What this means for the AD landscape?

If approved, amlitelimab could offer:

• A novel non–T cell depleting mechanism
• Potential Q12W maintenance dosing
• A new option for patients with inadequate response to current biologics

Two additional Phase 3 trials, AQUA and ESTUARY, are expected to read out in H2 2026.

Bottom line:

The growing Phase 3 dataset positions amlitelimab as a differentiated late-stage biologic candidate in atopic dermatitis, with the potential to combine durable efficacy, convenient dosing, and a novel immune-modulating mechanism.

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