Atopic Dermatitis Clinical Trial
Official title:
A Phase 3b/4 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Upadacitinib on Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis (SLEEP UP)
Many people with atopic dermatitis (AD) experience sleep disturbances. Greater sleep disturbances are associated with greater burden including increased sick days and impaired cognition. Patient focused research has found that sleep was one of the 3 most problematic symptoms for people with AD and their families. Upadacitinib demonstrated clinically meaningful sleep improvement based on patient-reported outcome measures such as the Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain score in Phase 3 registrational trials, but objective data on upadacitinib's effect on elements of sleep disturbance such as Wake After Sleep Onset, or Sleep Efficiency, have not been collected. Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 Periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib or Placebo. In Period 2, participants will be switched to receive open-label upadacitnib. Approximately 112 adult participants ages 25 to 63 with moderate to severe AD who have moderate to severe sleep disturbance will be enrolled at up to 32 sites worldwide. This study consists of a 35-day Screening Period; a 2-week randomized, double-blinded period (Period 1); a 22-week open-label extension period (Period 2); and a 30-day follow-up visit/call. Participants will receive oral tablets once per day of Upadacitinib or Placebo for 2 weeks followed by Upadacitinib oral tablet for 22 weeks There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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