ProjectM23-696 – A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing theSafety and Assessor…

Basic data

Acronym:
M23-696
Title:
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)
Duration:
26/01/2023 to 30/01/2025
Abstract / short description:
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.

Involved staff

Managers

Department of Dermatology
Hospitals and clinical institutes, Faculty of Medicine

Local organizational units

Department of Dermatology
Hospitals and clinical institutes
Faculty of Medicine

Funders

Wiesbaden, Hessen, Germany
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