strategic decision

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.

Inclusion Criteria:

• AD, according to Hanifin and Rajka criteria, with onset of symptoms at least 3 years prior to Baseline.
• Eczema Area and Severity Index (EASI) score >= 16; validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score >= 3, and >= 10% Body Surface Area (BSA) of AD involvement at the Baseline Visit.
• Baseline weekly average of daily Worst Pruritus Numeric Rating Scale (NRS) >= 7.
• Moderate to severe sleep disturbance as confirmed by Baseline Patient Global Impression (PGI) Sleep AD (7-day) score of 3 or 4.
• Documented history of inadequate response to at least 1 prior systemic treatment for AD OR for whom systemic treatments, other than upadacitinib, are medically inadvisable (e.g., because of important side effects or safety risks).

Exclusion Criteria:

• Prior exposure to dupilumab, tralokinumab, lebrikizumab, or nemolizumab.

• Conditions or circumstances that could interfere with sleep assessments, including but not limited to:

  • History of sleep apnea, hypersomnia, or insomnia related to chronic pain;
  • Participant uses a continuous positive airway pressure (CPAP) machine;
  • History of chronic obstructive pulmonary disease or uncontrolled asthma;
  • Evidence of restless leg syndrome;
  • Participant is an evening or night shift worker;
  • Participant has sleep disturbance due to menopause, nocturia, or situational circumstances (e.g., caring for infant).

• Participants who had prior exposure to any oral JAK inhibitor

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/