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

NCT06390722 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: M24-602
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atopic Dermatitis; Sleep Disturbance

Keywords

Upadacitinib; RINVOQ; ABT-494; Atopic Dermatitis; Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from Baseline in Total Scratch Time

  Baseline to Week 2

• Change from Baseline in Sleep Efficiency

  Baseline to Week 2

• Change from Baseline in Wake After Sleep Onset (WASO) based on a sleep sensor.

  Baseline to Week 2

• Change from Baseline in Nocturnal Scratching Bouts (≥ 5 seconds)

  Baseline to Week 2

Study Arms (2)

Upadacitinib

EXPERIMENTAL

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.

Drug: Upadacitinib

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo for Upadacitinib

Interventions

Upadacitinib DRUG

Oral Tablet

Also known as: RINVOQ

Upadacitinib

Placebo for Upadacitinib DRUG

Oral Tablet

Placebo

Eligibility Criteria

• Age: 25 Years - 63 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Dermatitis, Atopic; Parasomnias

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: May 23, 2024
• Primary Completion: January 5, 2026
• Study Completion (Estimated): July 8, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: 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/