WEDNESDAY, April 8, 2026 (HealthDay News) -- Amlitelimab, a fully human non-T cell depleting monoclonal antibody that selectively targets OX40-ligand (OX40L), is safe and effective, with potentially progressive efficacy over time, for patients with moderate-to-severe atopic dermatitis (AD), according to the results of three phase 3 studies presented at the annual meeting of the American Academy of Dermatology, held from March 27 to 31 in Denver.
In the SHORE study, Eric Simpson, M.D., from the Oregon Health & Science University in Portland, and colleagues assessed the safety and efficacy of amlitelimab in 643 patients 12 years and older with moderate-to-severe AD receiving topical corticosteroids with or without topical calcineurin inhibitors. Patients were randomly assigned 2:1:1 to receive placebo or amlitelimab subcutaneously as a 500-mg loading dose followed by 250 mg either every four weeks (Q4W) or every 12 weeks (Q12W), with or without topical medications for 24 weeks. The researchers found significantly higher efficacy for amlitelimab versus placebo for the primary end point of Validated Investigator Global Assessment scale for AD (vIGA-AD) of 0 (clear) or 1 (almost clear; 28.7 percent for the Q4W dosing and 32.3 percent for Q12W dosing versus 16.8 percent with placebo). There were also statistically significant improvements in key secondary end points of vIGA-AD 0/1 with barely perceptible erythema (BPE), a 75 percent or greater improvement in the Eczema Area Severity Index (EASI-75), and a ≥4-point reduction in the Peak Pruritus Numerical Rating Scale (PP-NRS).
In the COAST-1 and COAST-2 studies, Simpson and colleagues evaluated patients aged 12 years and older (601 and 589 participants, respectively) with moderate-to-severe atopic dermatitis who were randomly assigned 2:1:1 to subcutaneous amlitelimab Q4W plus a loading dose, amlitelimab Q12W plus a loading dose, or placebo for 24 weeks. The researchers found that in COAST 1, all prespecified end points were met with amlitelimab demonstrating significantly higher efficacy over placebo for vIGA-AD 0/1 (21.1 and 22.5 percent for Q4W and Q12W, respectively, versus 9.2 percent for placebo). The secondary end points were also met with statistical significance, including vIGA-AD 0/1 with BPE, EASI-75, and PP-NRS. In COAST 2, the researchers found amlitelimab met the primary end point (vIGA-AD 0/1: 25.3 and 25.7 percent for Q4W and Q12W, respectively, versus 14.8 percent with placebo), while there were nominally significant improvements in EASI-75 and PP-NRS. However, improvements in vIGA-AD 0/1 with BPE were not significant.
Amlitelimab was well tolerated, and no new safety signals were identified. Across studies, nasopharyngitis and upper respiratory tract infection were the most common treatment-emergent adverse events.
"Despite current medicines, a critical medical gap remains for moderate-to-severe atopic dermatitis patients and additional treatment options are needed," Simpson said in a statement. "These data, which show that amlitelimab delivers potentially progressive efficacy over time, further illustrate the potential of non-T cell depleting OX40L inhibition to help reduce disease severity and burdensome symptoms with less frequent dosing."
The studies were funded by Sanofi, which is developing amlitelimab.