Johnson & Johnson’s Icotrokinra Demonstrates Significant Skin Clearance in Adolescents with Moderate-to-Severe Plaque Psoriasis
In the Phase III ICONIC-LEAD trial, 75% of adolescents with moderate-to-severe plaque psoriasis treated with icotrokinra achieved completely clear skin by week 24.
Image Credit: Adobe Stock Images/hriana
Results from the Phase III ICONIC-LEAD study show that Johnson & Johnson’s (J&J) icotrokinra (JNJ-2113), a first-in-class oral peptide targeting the interleukin-23 receptor, produced significant skin clearance in adolescents with moderate-to-severe plaque psoriasis (PsO). Full data were presented at the 2025 World Congress of Pediatric Dermatology.1
“Data from the Phase III 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,” ICONIC-LEAD trial presenter Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology, Rady Children‘s Hospital-San Diego, professor of pediatrics and medicine (Dermatology), University of California, San Diego School of Medicine, said in a press release. “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 randomized, controlled ICONIC-LEAD trial evaluated the efficacy and safety of icotrokinra compared to placebo in 684 adolescents aged 12 years and older. The study's dual primary endpoints were a Psoriasis Area and Severity Index (PASI) score of 90 and an Investigator’s Global Assessment (IGA) score of 0 or 1 with at least a two-grade improvement.
At week 16, 84.1% of adolescents treated with icotrokinra achieved an IGA score of 0/1, while 70.5% achieved PASI 90 compared with 27.3% and 13.6%, respectively, in the placebo group. By week 24, 75% of patients achieved complete skin clearance (IGA 0), and 63.6% achieved PASI 100.
Icotrokinra demonstrated a favorable safety profile, with no new safety signals identified. At week 16, 50% of patients in the icotrokinra group experienced an adverse event (AE), compared to 73% in the placebo group.1
According to the National Psoriasis Foundation, over eight million people in the United States are living with psoriasis, a number that rises to 125 million globally. Additionally, about 30% of people with psoriasis will also develop psoriatic arthritis. The disease is likely underdiagnosed in African American and other populations of color, primarily due to differences in clinical presentation, according to the foundation. The current estimated prevalence of psoriasis is 1.5% in African Americans and 3.6% in Caucasians.3
“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, VP, immunohematology disease area lead, J&J Innovative Medicine, in the press release. “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.”
The ICONIC-LEAD trial is a part of the Phase III ICONIC clinical development program, along with ICONIC-TOTAL. Other studies currently in the ICONIC development program include ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, which are evaluating the efficacy and safety of icotrokinra compared to placebo and compared to Sotyktu (deucravacitinib). Additionally, ICONIC-ASCEND is expected to evaluate the efficacy and safety of icotrokinra compared with placebo and compared to Stelara (ustekinumab). Lastly, ICONIC-PsA 1 and ICONIC-PsA 2 are evaluating the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis.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. J&J. April 10, 2025. Accessed April 10, 2025. https://innovativemedicine.jnj.com/newsroom/immunology/icotrokinra-results-show-75-of-adolescents-with-plaque-psoriasis-achieved-completely-clear-skin-and-demonstrate-favorable-safety-profile-in-a-once-daily-pill
2. A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis (ICONIC-LEAD). Clinicaltrials.gov. Accessed April 10, 2025. https://clinicaltrials.gov/study/NCT06095115
3. Psoriasis Statistics. National Psoriasis Foundation. Accessed April 10, 2025. https://www.psoriasis.org/psoriasis-statistics
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