Oral IL-23 Receptor Antagonist Icotrokinra Demonstrates Significant Efficacy in Difficult-to-Treat Psoriasis Sites in Phase 3 Trial

Johnson & Johnson recently announced the latest Phase III clinical trial data for its investigational oral psoriasis drug icotrokinra (JNJ-2113), showing significant efficacy in traditionally difficult-to-treat areas such as the scalp, genitals, and hands and feet.

Icotrokinra is an orally administered peptide drug that selectively blocks IL-23R (Interleukin-23 receptor). It can bind to IL-23R with single-digit picomolar affinity and exerts potent selective inhibition of IL-23 signaling in human T cells. Compared to existing biologics or non-specific systemic treatments, this drug may offer a new oral treatment option that combines systemic efficacy with the convenience of once-daily dosing.

ICONIC-TOTAL is a Phase 3 randomized controlled trial (RCT) designed to evaluate the efficacy and safety of Icotrokinra compared to placebo in treating plaque psoriasis. The trial enrolled 311 participants (Icotrokinra=208; placebo=103) with at least moderate disease severity affecting special areas (e.g., scalp, genitals, and/or hands and feet), an Investigator Global Assessment (IGA) score of 0 or 1, and the primary endpoint being at least a 2-grade improvement.

Among patients treated with icotrokinra, 57% reached the primary endpoint at 16 weeks (Investigator Global Assessment [IGA] score 0/1, indicating complete or near-complete skin clearance and improvement of ≥2 grades from baseline), compared to only 6% in the placebo group.

Data for Specific Refractory Sites

Scalp Psoriasis: 66% of Patients Achieved Complete or Near-Complete Clearance of Scalp Skin (11% in the Placebo Group)

Genital Psoriasis: 77% of Patients Show Significant Improvement (21% in Placebo Group)

Psoriasis of the hands and feet: 42% of patients showed better skin clearance compared to the placebo group (26%).

Safety Advantages: As of Week 16, the incidence of adverse events in the icotrokinra group (50%) was comparable to that in the placebo group (42%), with a lower rate of serious adverse events. Analysts noted that, compared to JAK inhibitors or S1P modulators that require significant warnings, icotrokinra demonstrates clear safety advantages.

Reference Source:

Icotrokinra results show significant skin clearance in patients with difficult-to-treat scalp and genital psoriasis. News release. PR Newswire. Published May 9, 2025. Accessed May 9, 2025.

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