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PAXIS: A Phase 2a And 2b Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Pacritinib In Patients With VEXAS Syndrome
Scottsdale/Phoenix, AZ
Rochester, MN
This trial is to assess the effectiveness and safety of pacritinib in patients with VEXAS (i.e., Vacuoles in myeloid progenitors, E1 ubiquitin-activating enzyme, X-linked, autoinflammatory manifestations, and somatic) syndrome. In phase 2a, approximately 78 participants will be randomized to either pacritinib dose A, pacritinib dose B + placebo, or placebo. In Phase 2b, approximately 78 participants will be randomized. Phase 2b participants will initially be randomized to either pacritinib dose A, pacritinib dose B + placebo, or placebo. After dose selection, Phase 2b further participants will be randomized to either the selected pacritinib dose or placebo.
Randomization will be stratified by prescribed GC dose on the day of randomization.
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