Johnson & Johnson’s Icotrokinra Succeeds in Phase III Trial for Plaque Psoriasis in Adolescents

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Johnson & Johnson has shared positive data from a subgroup analysis of the Phase III ICONIC-LEAD clinical trial of its investigational icotrokinra for the treatment of moderate-to-severe plaque psoriasis. In the adolescent patient population, icotrokinra demonstrated higher rates of clear or almost clear skin at week 16 compared to those receiving placebo.¹

According to the study results, 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. In the placebo arm, just 27.3% and 13.6%, respectively, achieved these marks at week 16.

In a press release, 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, ICONIC-LEAD presenter, said: “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. 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.”

Positive results continued through week 24 of the trial, where response rates continued to improve. Of adolescents who received icotrokinra, 86.4% achieved IGA 0/1 (clear or almost clear skin) and 88.6% achieved PASI 90. At the week 24 mark, 75% of adolescents achieved IGA 0 (completely clear skin) and 63.6% achieved PASI 100.

In the press release, Liza O’Dowd, Vice President, immunodermatology disease area lead, Johnson & Johnson Innovative Medicine, added: “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. 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.”

Icotrokinra has also produced positive outcomes in ulcerative colitis through the Phase IIb ANTHEM-UC study. In March, Johnson & Johnson announced topline results from the trial which showed that icotrokinra achieved clinical remission rates up to 30.2% at week 12. Patients treated with the highest dose of the investigational therapy saw a response rate of 63.5% versus 27% for the placebo group.²

In a press release from the time, Esi Lamousé-Smith, MD, PhD, vice president, gastroenterology disease area lead, immunology, Johnson & Johnson, said: “These impressive findings show the potential of icotrokinra to transform the treatment paradigm for people living with ulcerative colitis by offering a distinctive combination of therapeutic benefit, tolerability, and convenience with a once-daily oral treatment. With over a quarter century of innovation in inflammatory bowel disease, coupled with our deep expertise in the IL-23 pathway, we are excited about these results and the groundbreaking potential of icotrokinra in the treatment of immune-mediated diseases.”

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. News release. Johnson & Johnson. April 10, 2025. Accessed April 15, 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. Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients. News release. Johnson & Johnson. March 10, 2025. Accessed April 15, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-meets-primary-endpoint-of-clinical-response-in-ulcerative-colitis-study-and-shows-potential-to-transform-the-treatment-paradigm-for-patients