JNJ-2113 for plaque psoriasis demonstrates clear skin in 75% of adolescents | Image Credit: © Ban - © Ban - stock.adobe.com.

On April 10, 2025, Johnson & Johnson (J&J) announced positive, phase 3 efficacy and safety data for JNJ-2113 (icotrokinra) to treat moderate-to-severe plaque psoriasis in adolescents aged 12 years and older, as well as adults.¹

According to J&J, data from the randomized controlled ICONIC-LEAD trial (NCT06095115)—presented at the 2025 World Congress of Pediatric Dermatology (WCPD) Annual Meeting—demonstrated that 84% of adolescents treated with the once daily pill achieved an Investigator's Global Assessment (IGA) score of 0/1 (clear or almost clear skin) at week 16. Further, 70.5% of adolescents achieved a 70.5% Psoriasis Area and Severity Index (PASI) 90 response versus 27.3% of adolescents who received placebo, respectively, at week 16.

ICONIC-LEAD is the first phase 3 registrational study to assess safety and efficacy of a systemic therapy among adolescents and adults simultaneously who have moderate-to-severe plaque psoriasis. The make-up of the trial includes 684 patients aged 12 years and up (66 adolescent patients), in which 456 participants receive JNJ-2113 and 228 receive placebo. Higher efficacy bar of PASI 90 and IGA score of 0/1 with at least a 2-grade improvement are co-primary endpoints.

Sustained efficacy of JNJ-2113 at week 24

Additional information announced by J&J included continued efficacy data at week 24, which revealed that 86.4% of adolescent patients achieved an IGA score of 0/1 while 88.6% achieved PASI 90. Of this group at week 24, 75% achieved a score of IGA 0, or completely clear skin, while 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, MD, in a statement. Eichenfield is the 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 School of Medicine, and in ICONIC-LEAD trial 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," added Eichenfield.

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JNJ-2113 safety data

Treatment with the investigational, targeted oral peptide designed to block the IL-23 receptor demonstrated a "favorable" safety profile according to J&J, as 50% of adolescents experienced ≥1 adverse event compared to the 73% of placebo-treated patients. Additionally, no new safety signals were identified.

Additional commentary

“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, 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.”

More clinical trial data on JNJ-2113

On November 20, 2024, positive data from the phase 3 ICONIC-TOTAL (NCT06095102) study was announced. This trial was comprised of 311 patients and met the primary endpoint of IGA 0/1 plus a 2-grade improvement at week 16 compared to placebo. ICONIC-TOTAL was among participants with at least moderate severity that affected special areas including the scalp, genital, and/or hands and feet.^1,2

J&J currently has other phase 3 studies in development, including ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604), which are evaluating the efficacy and safety of icotrokinra compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.¹

This trial aims to evaluate efficacy and safety of icotrokinra compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis.

Further, ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis.

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. Press release. April 10, 2025. Accessed April 10, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-75-of-adolescents-with-plaque-psoriasis-achieved-completely-clear-skin-and-demonstrate-favorable-safety-profile-in-a-once-daily-pill

2. Fitch J. New phase 3 data of JNJ-2113 for plaque psoriasis in patients aged 12 years, older. Contemporary Pediatrics. November 20, 2024. Accessed April 10, 2025. https://www.contemporarypediatrics.com/view/new-phase-3-data-of-jnj-2113-for-plaque-psoriasis-in-patients-aged-12-years-older