A Study to Assess the Effect of Upadacitinib in Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis

Sponsor
AbbVie
Study ID
NCT06390722
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 63 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 23, 2024
Status verified
Sep 2024
Primary completion
Jan 5, 2026
Completion
Jul 8, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Upadacitinib
    Participants randomized to receive upadacitinib Dose A once daily for 2 weeks during double-blind treatment period. At week 2, participants will be switched to open-label upadacitinib Dose A once daily for 22 weeks.
  • Placebo Comparator: Placebo
    Participants randomized to receive Placebo once daily for 2 weeks during double-blind treatment period. At week 2, participants will be switched to open-label upadacitinib Dose A once daily for 22 weeks.

Primary Outcome Measure

Percentage of participants achieving an improvement (reduction) in Worst Pruritus Numeric Rating Scale ≥ 4 from Baseline [ Time Frame: Baseline to Week 2 ]

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