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Ustekinumab has effects on both interleukin 12 (IL-12) and IL-23, but its effects on IL-23 are believed to be responsible for the improvements observed in treated patients with psoriasis. Tildrakizumab is a novel agent (not currently FDA-approved) that targets the p19 subunit of IL-23.
To evaluate the effectiveness, safety, and pharmacokinetics of tildrakizumab in psoriasis, researchers (including one employee of the manufacturer of tildrakizumab) conducted a phase 1 study. Part 1 of the study involved 24 patients randomized 1:3 to receive either placebo or one of four ascending doses of tildrakizumab, from 0.1 mg/kg to 10 mg/kg, infused intravenously. The patients received additional infusions at 8 weeks (after safety observation in the int…