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Background Sleep disturbance is a prominent symptom of atopic dermatitis (AD) and can result in insomnia, daytime fatigue, drowsiness, reduced productivity, and impaired quality of life (QoL). Objectives The DUPISTAD (Dupilumab Effect on Sleep in AD Patients) phase 4 randomized double-blinded placebo-controlled study evaluated the impact of dupilumab treatment on sleep and other patient- and physician-reported outcomes. Methods Adults with moderate-to-severe AD were randomized 2:1 to dupilumab 300 mg once every 2 weeks (q2w) or placebo for 12 weeks; concomitant topical corticosteroids were permitted. Patients subsequently entered an open-label phase and received dupilumab 300 mg q2w for a further 12 weeks. The primary endpoint was percentage change from baseline to Week 12 in sleep quality, assessed using a novel numeric rating scale (NRS). Secondary and exploratory endpoints included percent change in peak pruritus NRS (PP NRS), change in SCORing Atopic Dermatitis (SCORAD), SCORAD sleep visual analog scale (VAS), Eczema Area and Severity Index, Patient Reported Outcomes Measurement Information System (PROMIS) sleep-related impairment T-score, and the Epworth Sleepiness Scale (ESS). Sleep diary and wrist actigraphy measurements were recorded throughout the study. Results In total, 127 patients received dupilumab and 61 placebo. Demographic and baseline disease characteristics were balanced between groups. Sleep quality NRS significantly improved in dupilumab-treated patients by Week 12 versus placebo (LSMD-15.5%, P<0.001). PP NRS (LSMD -27.9%, P<0.001), SCORAD (LSMD -15.1, P<0.001), SCORAD sleep VAS (LSMD -2.1, P<0.001), and PROMIS T-score (LSMD -3.6, P<0.001) were also significantly improved at Week 12 with dupilumab versus placebo. The overall percentage of patients reporting treatment-emergent adverse events was lower in the dupilumab group (56.7%) than in the placebo group (67.2%). Conclusions Dupilumab significantly improved sleep quality and perception of sleep continuity, itch, metrics of AD severity, and QoL in adults with moderate-to-severe AD, with an acceptable safety profile versus placebo. Trial registration number ClinicalTrials.gov: NCT04033367

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