SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) has announced encouraging results from its Phase 3 investigational study of icotrokinra (JNJ-2113), a groundbreaking oral peptide designed to selectively block the IL-23 receptor. The drug showed significant skin clearance in adults and adolescents aged 12 and older with moderate to severe plaque psoriasis, according to data from the ICONIC-LEAD study.
The study reached its co-primary goals, with 64.7% of patients achieving “clear” or “almost clear” skin, defined by Investigator’s Global Assessment (IGA) scores of 0/1, at week 16. Nearly half, or 49.6%, attained at least a 90% improvement on the Psoriasis Area and Severity Index (PASI 90). These compared favorably to the placebo group, where only 8.3% and 4.4% of participants, respectively, reached the same milestones. Results continued to improve through week 24, with the proportions rising to 74.1% for IGA scores of 0/1 and 64.9% for PASI 90 in the icotrokinra group.
Safety outcomes were consistent with those seen in earlier trials (FRONTIER 1 and 2). Adverse events were comparable between the treatment and placebo groups, with 49.3% and 49.1% of participants reporting them by week 16.
Additional Phase 3 results from the ICONIC-TOTAL study supported these findings, with the study meeting its primary endpoint of IGA 0/1 by week 16. Comprehensive data from both ICONIC-LEAD and ICONIC-TOTAL are scheduled to be shared at forthcoming medical conferences and through regulatory submissions.
“We are excited to see impressive Phase 3 results with once-daily icotrokinra treatment aligned with our Phase 2 study of this first-in-class targeted oral peptide that selectively blocks the IL-23 receptor,” said Liza O’Dowd, Vice President, Immunodermatology Disease Area Lead at Johnson & Johnson Innovative Medicine. “The majority of people living with moderate to severe plaque psoriasis are eligible for, but are still not receiving, advanced therapies. Icotrokinra has the potential to offer once-daily oral therapy that could help address the needs and preferences of people living with plaque psoriasis.”
The ICONIC program includes additional ongoing studies. ICONIC-ADVANCE 1 and 2 are examining the drug’s safety and effectiveness compared to placebo and another psoriasis medication, deucravacitinib. Furthermore, the ICONIC-PsA study will explore its potential use for psoriatic arthritis, with plans to start in early 2025.
These studies represent a significant step forward in providing more accessible, convenient, and effective treatments for plaque psoriasis, a condition that impacts millions worldwide. Johnson & Johnson’s findings position icotrokinra as a promising option for those living with this chronic skin disorder.
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