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- W4366171287 abstract "Kamari is performing a clinical trial (KM001-AB1) evaluating the safety and efficacy of KM001, a novel topical TRPV3 inhibitor, in patients with moderate to severe pruritus caused by LSC. TRPV3 is a cation channel highly expressed in keratinocytes affecting proliferation, differentiation and inflammation processes and can be activated by various distinctive triggers. It was implicated in the pathogenesis of chronic pruritus and related to diseases such as atopic Dermatitis. The study taking place in Germany, is a multicenter study enrolling 51 patients treated for 4-weeks. Eligible patients demonstrate chronic moderate to severe pruritis (PPNRS score ≥7) and are diagnosed with LSC for at least 8 weeks. The patients are randomly assigned to one of 3 arms: 0.3% or 1% of KM001, or vehicle only control. The primary endpoint is safety and tolerability, including AE reporting, vital signs, ECG and laboratory assessments. Efficacy endpoints include changes in pruritus severity (PPNRS scale) and investigator global assessment (IGA). KM001's systemic exposure will be characterized through PK sampling. This is the first randomized, double-blind, vehicle-controlled study to assess the safety and efficacy of KM001 in the treatment of moderate to severe pruritus in LSC patients. Its design will allow a thorough assessment of the ability of KM001 to reduce pruritus, as well characterizing its safety and systemic plasma exposure. A sentinel group has completed the study without any serious or treatment-emergent adverse events. Topline results are expected during Q2 2023." @default.
- W4366171287 created "2023-04-19" @default.
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- W4366171287 date "2023-05-01" @default.
- W4366171287 modified "2023-09-28" @default.
- W4366171287 title "629 Evaluating the safety and efficacy of topical KM-001, a TRPV3 inhibitor, for treatment of pruritus in patients with Lichen Simplex Chronicus (LSC): A first in human, double-blind, randomized vehicle-controlled study" @default.
- W4366171287 doi "https://doi.org/10.1016/j.jid.2023.03.636" @default.
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