Icotrokinra Clears Skin Among 75% of Adolescents with Plaque Psoriasis

New findings from a subgroup analysis show that adolescents with moderate-to-severe plaque psoriasis given with once-daily icotrokinra (JNJ-2113) attained higher rates of clear or almost clear skin at the 16-week mark versus those given a placebo and that there were no new safety signals.1,2

These data, announced on April 10 by Johnson & Johnson, resulted from the ICONIC-LEAD study, the first ever phase 3 registrational analysis of moderate-to-severe plaque psoriasis to evaluate the safety and effectiveness of a systemic drug in both adolescents and adults simultaneously.1 The findings were presented at the 2025 World Congress of Pediatric Dermatology (WCPD) Annual Meeting.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," Lawrence Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital-San Diego, and professor of Pediatrics and Medicine at the University of California, San Diego (UCSD) School of Medicine, said in a statement.1

There are an estimated 8 million Americans and 125 million people around the world who live with plaque psoriasis, a chronic immune-mediated skin condition that is characterized by overproduction of skin cells and inflamed, scaly plaques that can itch or cause pain. Icotrokinra is being studied in adults and adolescents 12 years of age and older with moderate-to-severe psoriasis, with the medication being designed as a first-in-class investigational targeted oral peptide that can selectively block the interleukin (IL)-23 receptor.

The phase 3 ICONIC-LEAD randomized controlled trial (RCT) was set up to assess icotrokinra’s efficacy and safety as opposed to placebo among a total of 684 trial subjects.2 Specifically, the icotrokinra arm was made up of 456 individuals and the placebo arm was made up of 228. The ICONIC-LEAD investigators determined that the higher efficacy bar would be Psoriasis Area and Severity Index (PASI) 90 response and Investigator's Global Assessment (IGA) score of 0/1 (clear or almost clear skin) with at least a 2-grade improvement as primary endpoints.

The investigative team concluded that 84.1% of adolescent patients at Week 16 treated with once daily icotrokinra achieved an IGA score of 0/1. Additionally, they noted that 70.5% of the trial participants in the adolescent group attained a PASI 90 response at the same time point. This was compared to 27.3% and 13.6% of those in the placebo cohort, respectively.

Improvements in participants’ rates of response to the drug continued through to the 24-week mark, at which point 86.4% of adolescents were shown by the team to have attained IGA 0/1 scores and 88.6% to have attained PASI 90 scores.1,2 Additionally, 75% of these adolescents in the study’s sub-analysis achieved IGA 0 and 63.6% achieved PASI 100 at the 24-week mark.

In the team’s safety assessment, icotrokinra was found to have a favorable safety profile. 50% of adolescents at Week 16 who were in the icotrokinra cohort reported ≥1 adverse event (AE). This was compared to 73% of adolescents who had been in the placebo cohort, with no new safety signals being observed.1,2

“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,” Eichenfield said in his statement.1

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. 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. Eichenfield, L et al. Efficacy and Safety of Icotrokinra, a Novel Targeted Oral Peptide (IL-23R-inhibitor), in Adolescents With Moderate-to- Severe Plaque Psoriasis: Subgroup Analyses From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ICONIC-LEAD). Presented at the World Congress of Pediatric Dermatology (Abstract #0054). April 2025.