Icotrokinra results show significant skin clearance in patients with difficult to treat scalp, genital psoriasis: JnJ
Spring House: Johnson & Johnson has announced new data from the Phase 3 ICONIC-TOTAL study investigating icotrokinra (JNJ-2113), the first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor. The study evaluated adults and adolescents 12 years of age and older with body surface area as low as 1% and at least moderate plaque psoriasis (PsO) affecting high-impact skin sites.
Data presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting show 57% of patients treated with once daily icotrokinra achieved the study’s primary endpoint with an Investigator’s Global Assessment (IGA)b score of 0/1 (clear or almost clear skin) and a ≥2-grade improvement from baseline at Week 16 compared to 6% of patients receiving placebo (P<0.001).
Icotrokinra demonstrated high rates of skin clearance in patients with scalp psoriasis as 66% achieved a scalp-specific Investigator’s Global Assessment (ss-IGA)c score of 0/1 compared to 11% receiving placebo (P<0.001) at Week 16. At the same time point, among patients with genital psoriasis, 77% treated with icotrokinra achieved a static Physician’s Global Assessment of Genitalia (sPGA-G)d score of 0/1 compared to 21% receiving placebo (P<0.001). In the smaller subset of patients with hand/foot psoriasis, treatment with icotrokinra showed a numerically higher rate of skin clearance at Week 16 with 42% achieving a hand and/or foot Physician’s Global Assessment (hf-PGA)e score of 0/1 compared to 26% receiving placebo.
“While plaque psoriasis can appear in any location on the body, most high-impact skin sites affect areas critical for mobility, personal care, and intimacy, and can be very challenging to treat effectively. Notably, almost 80% of psoriasis patients experience scalp involvement,” said Melinda Gooderham, MSc, MD, FRCPC, SKiN Centre for Dermatology, Queen’s University, and Probity Medical Research, Peterborough, ON, Canada and ICONIC-TOTAL study investigator. “Results from the ICONIC-TOTAL study demonstrate impressive rates of skin clearance in these difficult-to-treat areas and show the potential for treatment with icotrokinra to offer patients a novel therapeutic option that aligns with their treatment needs and preferences.”
Icotrokinra demonstrated a favorable safety profile. A similar proportion of patients experienced adverse events (50% and 42%) and serious adverse events (0.5% and 1.9%) in icotrokinra and placebo respectively through Week 16, with no new safety signals identified.
“When plaque psoriasis affects sensitive areas of the body, patients often experience unique challenges that can have a profound impact on their daily lives,” said Liza O’Dowd, MD, Vice President, Immunodermatology Disease Area Lead, Johnson & Johnson Innovative Medicine. “These new findings build upon the impressive scalp psoriasis results seen in ICONIC-LEAD and strengthen the breadth of data demonstrating the potential for icotrokinra to shift the treatment paradigm in moderate-to-severe plaque psoriasis, by offering a combination of skin clearance and favorable safety in a once daily pill.”
