Phase 3 studies show sustained skin clearance through 52 weeks.
Johnson & Johnson reported new 52-week data from its Phase 3 ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies evaluating icotrokinra (ICOTYDE) for moderate-to-severe plaque psoriasis, according to a company announcement. The data were presented at the 2026 American Academy of Dermatology Annual Meeting.
According to the company, rates of completely clear skin (PASI 100) increased between Week 24 and Week 52 in the ICONIC-ADVANCE trials. In ADVANCE 1, rates increased from 41% to 49%, and in ADVANCE 2, from 33% to 48%.
Patients who switched from placebo to icotrokinra at Week 16 achieved similar rates of complete skin clearance by Week 52 as those treated continuously, with reported PASI 100 rates of 50% and 43% in ADVANCE 1 and 2, respectively.
“Introducing a once-daily targeted oral peptide for treating moderate-to-severe plaque psoriasis offers patients an option with a unique combination of benefits and a favorable safety profile,” says Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health and an ICONIC-ADVANCE study investigator, in a release. “The results from one-year studies show encouraging outcomes for patients as they navigate this chronic condition.”
Johnson & Johnson notes the safety profile through 52 weeks was consistent with earlier findings, with no new safety signals identified. The company also reports that overall adverse event and infection rates were lower than deucravacitinib through Week 24.
In the ICONIC-LEAD study, which included adolescents, nearly 60% of patients treated with icotrokinra achieved completely clear skin at Week 52 (57% PASI 100, 61% IGA 0), according to the company. The company also reported that 86% of adolescents achieved PASI 90 at one year, with 92% maintaining that response from Week 24 to Week 52.
Johnson & Johnson says no increase in adverse event incidence was observed over one year of treatment in adolescents.
“For the first time, patients 12 and older have access to a novel therapy capable of delivering sustained skin clearance and a favorable safety profile in a once-daily pill,” said Jennifer Soung, MD, director of clinical research at Southern California Dermatology and an ICONIC-LEAD study investigator.
Johnson & Johnson announced US Food and Drug Administration approval for icotrokinra last month.
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