The primary completion status for a Phase 3 study (NCT06390722) investigating upadacitinib (Rinvoq) for atopic dermatitis-induced sleep disturbance was withdrawn on January 5, 2026. The trial, designed to assess the effect of upadacitinib on sleep disturbance in adults with moderate to severe atopic dermatitis, reported zero participants enrolled. While upadacitinib has shown clinically meaningful sleep improvement in previous Phase 3 registrational trials based on patient-reported outcomes, this specific study will not provide further objective data.
Background
Atopic dermatitis (AD) is a chronic inflammatory skin condition that frequently leads to significant sleep disturbances. These sleep issues are associated with a greater overall burden on patients, including an increased number of sick days and impaired cognitive function. Patient-focused research has consistently highlighted sleep disturbance as one of the three most problematic symptoms reported by individuals with AD and their families. Previous Phase 3 registrational trials have indicated that upadacitinib can lead to clinically meaningful sleep improvement, as evidenced by patient-reported outcome measures such as the Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain score. However, there remains a need for objective data on upadacitinib's effect on specific elements of sleep disturbance.
Trial design
The study (NCT06390722) was a Phase 3 trial titled "A Study to Assess the Effect of Upadacitinib in Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis." It was designed to investigate upadacitinib against a placebo for its effect on sleep disturbance in adults with moderate to severe atopic dermatitis. The trial's overall status is WITHDRAWN, and it reported zero participants enrolled.
What this means
The withdrawal of this Phase 3 study for upadacitinib, with no participants enrolled, indicates that no new data regarding its effect on atopic dermatitis-induced sleep disturbance will be generated from this specific trial. While prior studies have suggested benefits, this particular investigation will not contribute further evidence to the understanding of upadacitinib's impact on objective sleep parameters in this patient population.
Source
The information regarding the withdrawal of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT06390722, titled "A Study to Assess the Effect of Upadacitinib in Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis," was updated on January 5, 2026, on clinicaltrials.gov.