Two-year ICONIC-LEAD data: oral icotrokinra sustained high skin clearance through Week 112 in plaque psoriasis
Johnson & Johnson announced October 9, 2026 that two-year Phase 3 ICONIC-LEAD results showed at least 72% of icotrokinra-treated adults and adolescents maintained PASI 90 from Week 64 through Week 112, with no new safety signals identified over two years of treatment.
Johnson & Johnson announced on October 9, 2026 new two-year results from the Phase 3 ICONIC-LEAD study evaluating ICOTYDE (icotrokinra), described by the company as the first and only targeted oral peptide that blocks the IL-23 receptor, in adults and pediatric patients 12 years of age and older with moderate-to-severe plaque psoriasis. The data were presented at Fall Clinical Dermatology (FCD) 2026.
High levels of skin clearance were sustained through two years: at least 72% of icotrokinra-treated patients achieved a Psoriasis Area and Severity Index 90 response (PASI 90) and at least 70% achieved clear or almost clear skin (IGA 0/1) from Week 64 through Week 112. Complete skin clearance was also sustained, with at least 44% achieving PASI 100 and at least 46% achieving IGA 0, and clinically meaningful itch improvement was sustained in 78% of patients over the same period.
Among PASI 90 responders who were withdrawn from icotrokinra at Week 24, 85% regained a PASI 90 response within 24 weeks of retreatment. Safety findings through Week 112 remained consistent with the established profile, with no new safety signals identified.
ICONIC-LEAD is a Phase 3 randomized controlled trial in 684 participants (456 icotrokinra, 228 placebo) aged 12 and older with moderate-to-severe plaque psoriasis, including 66 adolescent patients, with co-primary endpoints of PASI 90 and IGA 0/1 with at least a 2-grade improvement. 'With two-year data that show long-term skin clearance and a consistent safety profile, ICOTYDE is transforming how we think about plaque psoriasis treatment,' said study investigator Mark Lebwohl, MD, of the Icahn School of Medicine at Mount Sinai, who the company discloses is a paid consultant.
Context and limits: these are company-announced long-term results presented at a medical conference; the underlying data have not been independently reviewed here. Approval status and labeling for icotrokinra vary by jurisdiction and indication. This brief reports study findings dated October 9, 2026 and is not a treatment recommendation.