A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab - Trial NCT06389136
Access comprehensive clinical trial information for NCT06389136 through Pure Global AI's free database. This Phase 3 trial is sponsored by AbbVie and is currently Not yet recruiting. The study focuses on Atopic Dermatitis. Target enrollment is 300 participants.
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Study Focus
Sponsor & Location
AbbVie
Timeline & Enrollment
Phase 3
May 24, 2024
Mar 09, 2026
Primary Outcome
Participants who achieve a composite endpoint of both a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1)
Summary
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to
 inflammation of the skin. Therapies spread over the skin may not be enough to control the AD
 in trial participants who require systemic anti-inflammatory treatment. This study aims to
 provide data on the efficacy and safety of upadacitinib at different doses in adult
 participants with moderate to severe AD.
 
 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 Dose A or dupilumab
 Dose A. Based on the participants response to upadacitinib Dose A, they may have their dose
 increased to upadacitinib Dose B after 2 weeks. In Period 2, participants that completed
 Period 1 will either remain on their assigned dose or be reassigned to a different dose based
 on their Eczema Area and Severity Index (EASI) response. Approximately 300 adult participants
 ages 18 to 64 with moderate to severe AD who are current users of dupilumab and had a history
 of inadequate response to dupilumab will be enrolled at up to 94 sites worldwide.
 
 The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a
 24-week Open-Label Period 2 for participants that completed Period 1. Participants will
 receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every
 other week for 32 weeks and followed for 30 days.
 
 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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06389136
Non-Device Trial