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

Atopic Dermatitis Clinical Trial

— Sleep Up  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06390722
• Other study ID #: M24-602
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 23, 2024
• Est. completion date: July 8, 2026

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: July 8, 2026
• Est. primary completion date: January 5, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 63 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Dyssomnias
• Eczema
• Parasomnias
• Sleep Disturbance

Intervention

Drug:
• Upadacitinib
Oral Tablet
• Placebo for Upadacitinib
Oral Tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants achieving an improvement (reduction) in Worst Pruritus Numeric Rating Scale = 4 from Baseline	The Worst Pruritus Numeric Rating Scale is an assessment tool that participants used to report the intensity of their pruritus during a daily recall period. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst imaginable itch'.	Baseline to Week 2
Secondary	Change from Baseline in Total Scratch Time	Scratch time will be measured in duration of seconds based on a wearable scratch sensor per sleep opportunity hour at Week 2 .; Note: Sleep opportunity is defined as total time spent trying to sleep [i.e., sleep sensor on to sensor off time].	Baseline to Week 2
Secondary	Change from Baseline in Sleep Efficiency	A wearable sleep sensor collects actigraphy, temperature, and heart rate data to quantify sleep parameters	Baseline to Week 2
Secondary	Change from Baseline in Wake After Sleep Onset (WASO) based on a sleep sensor.	A wearable sleep sensor collects actigraphy, temperature, and heart rate data to quantify sleep parameters	Baseline to Week 2
Secondary	Change from Baseline in Nocturnal Scratching Bouts (= 5 seconds)	Scratch time will be measured in duration of seconds based on a wearable scratch sensor per sleep opportunity hour at Week 2 .; Note: Sleep opportunity is defined as total time spent trying to sleep [i.e., sleep sensor on to sensor off time].	Baseline to Week 2

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