Johnson & Johnson (JNJ) reports Icotrokinra results show significant skin clearance in patients with difficult-to-treat scalp and genital psoriasis

Johnson & Johnson (NYSE: JNJ) today announced new data from the Phase 3 ICONIC-TOTAL^a 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).¹

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).ⁱ 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.^f "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.¹

"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."

Editor's notes:

a. ICONIC-TOTAL is a Phase 3 randomized controlled trial (RCT) evaluating the efficacy and safety of icotrokinra compared with placebo for the treatment of plaque PsO in 311 participants (icotrokinra=208; placebo=103) with at least moderate severity affecting special areas (e.g., scalp, genital and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint.

b. The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, and 4 indicates severe disease.²

c. The ss-IGA is a five-point scale where scalp lesions are assessed in terms of clinical signs of redness, thickness, and scaliness on a severity score ranging from 0 to 4, where 0 indicates absence of disease, 1 is very mild, 2 is mild, 3 is moderate and 4 indicates severe disease.

d. The sPGA-G is a six-point scale used to evaluate the severity of genital psoriasis at a given time point ranging from 0 to 5, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, 4 is severe and 5 indicates very severe disease.³

e. The Physician's Global Assessment of Psoriasis on the Hands and/or Feet (hf-PGA) assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet as: clear (0), almost clear (1), mild (2), moderate (3) and severe (4).⁴

f. Dr. Melinda Gooderham is a paid consultant for Johnson & Johnson. She has not been compensated for any media work.

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