Dose-Flexibility Study of Upadacitinib in Adults w Atopic Dermatitis
Research type
Research Study
Full title
A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis (Flex-Up)
IRAS ID
1006157
Contact name
Bernhard Dodell
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2022-000434-42
Clinicaltrials.gov Identifier
Research summary
Research 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 evaluates the dosing flexibility of upadacitinib in adult participants with moderate to severe AD. Adverse events and change in the disease activity will be assessed.
Upadacitinib is an approved drug for the treatment of moderate to severe/active immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and AD. The study is comprised of a 35-day Screening Period, a 12-week double-blind period and a 12-week single-blind period. During the double-blind period, participants are placed in 1 of 2 groups, called treatment arms and will be randomized in a 1:1 ratio to receive upadacitinib. At 12 weeks during the single blind period, participants will be blinded to the upadacitinib dose based on their EASI response and reassigned to in 1 of 4 arms. After the last study visit, there is a 30-day follow-up visit. Approximately 454 adult participants ages 18 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 160 sites worldwide.
The study is comprised of a 12-week double-blind period, followed by a 12-week single-blind period. Participants will receive upadacitinib oral tablets once daily for up to 24 weeks.Summary of Results
The study was completed as planned. The main goal of the study was to determine the percentage of patients that achieved at least a 90% improvement in the Eczema Area and Severity Index (EASI 90) after 24 weeks of treatment (Part 2) when allowing dose adjustment between low and high dose of upadacitinib. The EASI evaluates the severity and area affected by AD with scores ranging from 0 to 72. Higher scores represent more severe disease. Patients were assessed after 12 weeks of treatment (Part 1) and their response to treatment determined the dose (amount) of upadacitinib they received in Part 2: Group 1: upadacitinib low dose in Part 1 and Part 2 Group 2: upadacitinib low dose in Part 1 and upadacitinib high dose in Part 2 Group 3: upadacitinib high dose in Part 1 and Part 2 Group 4: upadacitinib high dose in Part 1 and upadacitinib low dose in Part 2 At Week 24, EASI 90 was achieved by: Group 1: 74.6% of patients Group 2: 48.1% of patients Group 3: 29.3% of patients Group 4: 68.5% of patients
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REC name
Wales REC 3
REC reference
23/WA/0176
Date of REC Opinion
5 Sep 2023
REC opinion
Further Information Favourable Opinion