M23-696- Level Up
Research type
Research Study
Full title
A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects with Moderate to Severe Atopic Dermatitis (Level-Up)
IRAS ID
1006502
Contact name
Aleksandra Jankielewicz
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG (AbbVie)
Eudract number
2022-002482-15
Clinicaltrials.gov Identifier
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 compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.
Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment period 1 and a 16-week treatment period 2.
During period 1, participants are placed in 1 of 2 groups, called treatment arms and will be randomized in a 1:1 ratio to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B.
Approximately 880 adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide. Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days.REC name
Wales REC 3
REC reference
23/WA/0005
Date of REC Opinion
5 Jul 2023
REC opinion
Further Information Favourable Opinion