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On August 11, 2025, we reported on findings from the ICONIC-LEAD clinical trial presented at the Dermatology Education Foundation (DERM) 2025 NP/PA CME Conference, July 23-26, 2025, in Las Vegas, Nevada.
The study
ICONIC-LEAD was a multicenter, randomized, double-blind, placebo-controlled phase 3 trial conducted at 170 sites worldwide. Researchers enrolled 684 participants aged 12 years or older with 10% or more body surface area (BSA) involvement, a Psoriasis Area and Severity Index (PASI) score of 12 or greater, and an Investigator’s Global Assessment (IGA) score 3 or greater.
The investigators randomized participants 2:1 to receive icotrokinra 200 mg once daily for 24 weeks (n=456) or placebo for 16 weeks followed by icotrokinra (n=228). The coprimary endpoints, assessed at week 16, were the proportion of participants achieving PASI 90 and the proportion achieving an IGA score of 0 or 1 (clear or almost clear) with at least a 2-grade improvement from baseline.
The findings
At the 16-week mark, significantly greater proportions of icotrokinra-treated participants achieved the study's endpoints compared to those receiving placebo:
IGA 0/1: 65% vs 8%
PASI 90: 50% vs 4%
IGA 0: 33% vs 1%
PASI 100: 27% vs <1%
(All comparisons multiplicity-adjusted P <.001)
Continued icotrokinra treatment through week 24 further increased response rates:
IGA 0/1: 74%
PASI 90: 65%
IGA 0: 46%
PASI 100: 40%
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