Treatment of Plaque Psoriasis Involving High-Impact Sites with Icotrokinra, a Targeted Oral Peptide: Pooled Analyses of 4 Phase 3 Placebo-Controlled Trials

Document Type

Conference Proceeding

Publication Date

7-1-2026

Publication Title

J Am Acad Dermatol

Keywords

Dermatology

Abstract

Introduction: Icotrokinra (ICO), a first-in-class targeted oral peptide that binds the IL-23R to inhibit IL-23-pathway signaling, is being evaluated in moderate-to-severe plaque psoriasis (ICONIC-LEAD[NCT06095115], ICONIC-ADVANCE-1[NCT06143878], and ICONIC-ADVANCE-2[NCT06220604]) and plaque psoriasis involving difficult-to-treat, high-impact sites (ICONIC-TOTAL[NCT06095102]). ICO demonstrated significantly higher Week(W)16 skin clearance rates, including in the scalp and genital areas in ICONIC-TOTAL, and a similar adverse event profile vs placebo (PBO).1-3 Pooled analyses were conducted across these four phase 3 trials (ICONIC-LEAD, ICONIC-ADVANCE-1, ICONIC-ADVANCE-2, and ICONIC-TOTAL) to evaluate the effect of ICO on difficult-to-treat, high-impact site (scalp, genitals, hands/feet) psoriasis. Methods: Participants (pts) were randomized 2:1 (ICONIC-LEAD, -TOTAL, -ADVANCE-1) or 4:1 (ICONIC-ADVANCE-2) to once-daily oral ICO 200mg or PBO through W16. Assessments included scalp-specific Investigator’s Global Assessment (ss-IGA), Static Physician’s Global Assessment of Genitalia (sPGA-G), and PGA of hands and feet (hf-PGA) in pts with at least moderate severity of high-impact site psoriasis (score ≥3) through W16. Results: At baseline, among 1866 pooled ICONIC-LEAD, -TOTAL, and -ADVANCE-1&2 pts, 1343 (72%), 473 (25%), and 443 (24%) had a score of ≥3 on ss-IGA, sPGA-G, and hf-PGA, respectively, and were included in applicable subgroup analyses. At W16, ICO demonstrated substantially higher rates vs PBO for achievement of clear/almost clear scalp (ss-IGA0/1: 72% vs 16%), genital (sPGA-G0/1: 76% vs 29%), and hand/foot (hf-PGA0/1: 64% vs 23%) psoriasis. Conclusions: In these large cohorts of pts with at least moderate severity high-impact site psoriasis, ICO demonstrated high rates of clearance at W16, with >70% and >60% achieving clear/almost clear scalp/genital psoriasis and hand/foot psoriasis, respectively.

Volume

95

Issue

1

First Page

AB457

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