M17-380 Upa to Dupi in Paediatric patients with Atopic Dermatitis
Research type
Research Study
Full title
A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children from 2 to Less than 12 Years of Age with Moderate to Severe Atopic Dermatitis
IRAS ID
1010033
Contact name
Alice Butler
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2023-504713-76
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 participants with moderate to severe AD who are candidates for systemic therapy. Adverse events and change in the disease activity will be assessed.
Upadacitinib is an approved drug for treating AD patients aged 12 or older. Participants will receive upadacitinib or dupilumab every 2 weeks or 4 weeks depending on disease severity, age and response to previous treatment. There is 1 in 5 chance for participants to receive dupilumab. Approximately 786 participants aged 2-12 years will be enrolled in this study at approximately 150 sites worldwide.
Participants will receive upadacitinib oral tablets once daily for 160 weeks, or dupilumab as per its label for 52 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.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
24/EM/0162
Date of REC Opinion
22 Aug 2024
REC opinion
Further Information Favourable Opinion