April 10, 2025: “Johnson & Johnson announced new icotrokinra (JNJ-2113) data from a subgroup analysis of ICONIC-LEAD, the first ever Phase 3 registrational study in moderate-to-severe plaque psoriasis (PsO) to assess efficacy and safety of a systemic therapy in adolescents and adults simultaneously.
These data, presented at the 2025 World Congress of Pediatric Dermatology (WCPD) Annual Meeting, show adolescents treated with once daily icotrokinra achieved higher rates of clear or almost clear skin at Week 16 compared to patients receiving placebo with no new safety signals identified.
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor and is being studied in adults and adolescents 12 years of age and older with moderate-to-severe plaque PsO.
In the study, 84.1% of adolescent patients treated with once daily icotrokinra achieved an Investigator’s Global Assessment (IGA) score of 0/1 (clear or almost clear skin) and 70.5% achieved a Psoriasis Area and Severity Index (PASI) 90 response, compared to 27.3% and 13.6% receiving placebo, respectively, at Week 16.
Response rates continued to improve through Week 24 where 86.4% of adolescents achieved IGA 0/1 (clear or almost clear skin) and 88.6% achieved PASI 90. Further, at Week 24, 75% of adolescents achieved IGA 0 (completely clear skin) and 63.6% achieved PASI 100.
“Data from the Phase 3 ICONIC LEAD subgroup analysis demonstrate impressive efficacy rates, showing the promise of this novel therapeutic option in the treatment of adolescents with moderate-to-severe plaque psoriasis who’ve often not yet received an advanced therapy,” said Lawrence Eichenfield, M.D., Chief of Pediatric and Adolescent Dermatology at Rady Children‘s Hospital-San Diego, and Professor of Pediatrics and Medicine (Dermatology), at the University of California, San Diego (UCSD) School of Medicine, ICONIC-LEAD presenter.
“Young patients with plaque psoriasis face unique challenges due to the visible and uncomfortable nature of the disease, making effective treatment options that align with their needs and preferences all the more important.”
Icotrokinra demonstrated a favorable safety profile. At Week 16, 50% of adolescents treated with icotrokinra experienced ≥1 adverse event (AE), compared to 73% of adolescents receiving placebo, with no new safety signals identified.
“Adolescents living with moderate to severe plaque psoriasis shouldn’t have to wait for effective treatments options that have the potential to deliver completely clear skin, which is the driving force for studying this younger population as part of the pivotal ICONIC program,” said Liza O’Dowd, Vice President, Immunodermatology Disease Area Lead, Johnson & Johnson Innovative Medicine.
“These data underscore the promise of next-generation therapies and the potential for icotrokinra to offer adolescents with moderate-to-severe plaque psoriasis the unique combination of a favorable safety profile and complete skin clearance in a once-daily pill.”
