Icotrokinra Shows Clear Skin in 75% of Adolescents With Plaque Psoriasis in Phase 3 Trial

Today, Johnson & Johnson announced promising new phase 3 data for icotrokinra (JNJ-2113), a first-in-class oral interleukin (IL)-23 receptor antagonist, showing that 75% of adolescents with moderate to severe plaque psoriasis achieved completely clear skin by week 24.¹

Presented at the 2025 World Congress of Pediatric Dermatology annual meeting, the subgroup analysis from the ICONIC-LEAD (NCT06095115) trial marks the first registrational study to simultaneously evaluate systemic therapy in both adolescents and adults, signaling a potential breakthrough for younger patients who often lack access to advanced treatment options.

Earlier this year, topline results from the phase 3 ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) trials confirmed that icotrokinra met its coprimary end points of an Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear) and Psoriasis Area and Severity Index (PASI) 90 at week 16 compared with placebo.²

"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 study presenter Lawrence Eichenfield, MD, 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, in a statement.¹ "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."

The study included 684 participants aged 12 and older with moderate to severe plaque psoriasis, including 66 adolescent patients. Participants were randomized to receive either icotrokinra or placebo, with coprimary end points of achieving a PASI 90 response and an IGA score of 0/1 with at least a 2-grade improvement from baseline.

At week 16, 84.1% of adolescents treated with icotrokinra achieved IGA 0/1, and 70.5% achieved PASI 90, compared with 27.3% and 13.6% in the placebo group, respectively. Efficacy continued to improve through week 24, with 86.4% achieving IGA 0/1 and 88.6% reaching PASI 90. Additionally, 75% of adolescents achieved completely clear skin (IGA 0), and 63.6% achieved PASI 100 at week 24. The safety profile was favorable, with fewer adolescents reporting adverse events in the icotrokinra group (50%) compared with placebo (73%), and no new safety signals were identified.

"Adolescents living with moderate to severe plaque psoriasis shouldn't have to wait for effective treatment 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, in a statement. "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."

References

1. Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin and demonstrate favorable safety profile in a once daily pill. Johnson & Johnson. News release. April 10, 2025. https://www.prnewswire.com/news-releases/icotrokinra-results-show-75-of-adolescents-with-plaque-psoriasis-achieved-completely-clear-skin-and-demonstrate-favorable-safety-profile-in-a-once-daily-pill-302425136.html

2. Andrus E. Icotrokinra demonstrates promise in phase 3 ICONIC-LEAD and ICONIC-ADVANCE for plaque psoriasis. Dermatology Times®. March 11, 2025. Accessed April 10, 2025. https://www.dermatologytimes.com/view/icotrokinra-demonstrates-promise-in-phase-3-iconic-lead-and-iconic-advance-for-plaque-psoriasis