M23-696

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing theSafety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects with Moderate to SevereAtopic Dermatitis (Level-Up)

26.01.2023 bis 30.01.2025

Upadacitinib is an oral, once-daily, selective, and reversible smallmolecule JAK inhibitor, engineered to have greater inhibitory potency for JAK1 versus JAK2, JAK3, and tyrosine kinase 2 (TYK2). Janus kinase 1 inhibition blocks the signaling of many important pro-inflammatory cytokines, including interleukin (IL)-2, IL-6, IL-7, and IL-15, IFNγ, which are known contributors to inflammatory disorders. It also blocks the signaling of IL-4, IL-13, IL-31, IL-22, IFN-γ, TSLP cytokines that play an important role in the pathogenesis of atopic dermatitis (AD). Upadacitinib has been approved for the treatment of moderate to severe/active immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and AD. Dupilumab is a recombinant human IgG4 monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling. Dupilumab inhibits IL-4 signaling via the Type I receptor (IL-4Rα/γc), and both IL-4 and IL-13 signaling through the Type II receptor (IL-4Rα/IL-13Rα). Dupilumab has been approved for the treatment of moderate to severe AD, severe asthma and severe chronic rhinosinusitis with nasal polyposis in the EU.