Core Insights - Amlitelimab, a monoclonal antibody targeting OX40-ligand, met all primary and key secondary endpoints in the COAST 1 phase 3 study for atopic dermatitis, showing significant skin clearance and reduced disease severity compared to placebo at Week 24 [1][2][5] - The study demonstrated that amlitelimab can be administered every four or twelve weeks, potentially allowing for only four doses per year, which may represent a significant advancement in treatment options for atopic dermatitis [2][5][10] Study Details - The COAST 1 study was a randomized, double-blind, placebo-controlled trial involving 601 participants aged 12 years and older with moderate-to-severe atopic dermatitis, conducted across 15 countries [9] - Key endpoints included the proportion of patients achieving a validated investigator global assessment scale for AD (vIGA-AD) of 0 or 1 and a reduction from baseline score of ≥2 points, as well as a 75% or greater improvement in the eczema area and severity index total score (EASI-75) [2][3][9] Efficacy Results - At Week 24, 21.1% of patients on Q4W and 22.5% on Q12W achieved vIGA-AD 0/1 compared to 9.2% in the placebo group, with p-values <0.01 [3] - EASI-75 was achieved by 35.9% of patients on Q4W and 39.1% on Q12W, compared to 19.1% in the placebo group, with p-values <0.001 [3] Safety Profile - Amlitelimab was well-tolerated, with no new safety concerns identified; the most common treatment-emergent adverse events were mild and included atopic dermatitis, nasopharyngitis, and upper respiratory tract infection, all more common in the placebo group [7][8] - Injection site reactions were slightly higher in the amlitelimab arms (2.2%) compared to placebo (0.7%), but all were mild and resolved without discontinuation of the study medication [7] Future Outlook - Additional phase 3 results from the OCEANA clinical development program, which includes COAST 1 and four other studies, are expected through 2026 and will inform potential global regulatory submissions [8][10] - Amlitelimab is under clinical investigation and has not yet been evaluated by any regulatory authority [8]