SPRING HOUSE, PA — Johnson & Johnson has unveiled new data from Phase 3 trials for icotrokinra (JNJ-2113), an investigational oral peptide targeting the IL-23 receptor, showing significant promise for treating moderate-to-severe plaque psoriasis (PsO). The company also announced the initiation of a groundbreaking head-to-head study to evaluate its superiority over the injectable biologic ustekinumab.
Key findings from the Phase 3 ICONIC-LEAD study, presented at the 2025 American Academy of Dermatology Annual Meeting, demonstrate the efficacy of once-daily icotrokinra. By Week 16, 65% of patients achieved clear or nearly clear skin (IGA 0/1), and 50% reached a PASI 90 response. By Week 24, these numbers rose to 74% and 65%, respectively, with nearly half achieving complete skin clearance. The safety profile remained favorable, with comparable adverse event rates between icotrokinra and the placebo group (49% each).
“People living with moderate-to-severe plaque psoriasis are seeking options that balance efficacy, safety, and ease of use,” said Dr. Robert Bissonnette, ICONIC-LEAD study investigator. “These study results are promising, and show the potential for treatment with icotrokinra to offer patients the unique combination of complete skin clearance and a favorable safety profile in a once-daily pill.”
Further reinforcing these results, the ICONIC-ADVANCE 1&2 studies revealed icotrokinra’s superiority over deucravacitinib while achieving all co-primary and key secondary endpoints. These successes form the basis for the ICONIC-ASCEND trial, the first clinical study to compare an oral treatment against an injectable biologic in PsO.
“The robust results seen to date underscore the potential for icotrokinra to shift treatment expectations in moderate-to-severe plaque psoriasis,” said Liza O’Dowd, Vice President, Immunodermatology Disease Area Lead at Johnson & Johnson Innovative Medicine. “As part of our ongoing commitment to pioneer innovations for patients, we are proud to advance this first-in-class investigational targeted oral peptide.”
If successful in the ASCEND study, icotrokinra could pave the way for a treatment paradigm shift, potentially becoming a first-line option for PsO patients prioritizing efficacy, safety, and convenience.
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