Icotrokinra Shows 2-Year Efficacy in High-Impact Psoriasis Areas

Icotrokinra, an oral peptide targeting the interleukin-23 receptor, demonstrated sustained clinical efficacy through two years in patients with moderate to severe psoriasis affecting high-impact areas such as the scalp, genitals, hands, feet, and nails. Presented at the European Academy of Dermatology and Venereology 2026 Congress by Richard B. Warren, the late-breaker data from the ICONIC-TOTAL trial confirm long-term disease clearance without unexpected safety signals.

Icotrokinra Clears Skin in Hard-To-Treat Zones

• What it is: Icotrokinra is an oral pill designed to block interleukin-23, a key protein that drives inflammation in plaque psoriasis.
• The results: In a phase 3 clinical trial tracking 311 patients over 112 weeks, a significant majority of individuals achieved clear or almost clear skin in hard-to-treat anatomical zones like the scalp and genitals.
• Safety profile: Adverse events remained low and comparable to placebo groups throughout the extended two-year observation window, matching the safety profile seen in injectable biologic therapies.

Two-Year Efficacy in High-Impact Psoriasis Zones

The ICONIC-TOTAL trial evaluated 311 patients aged 12 and older diagnosed with moderate to severe plaque psoriasis involving at least one high-impact area. During the initial 16-week blinded phase, participants received either 200 mg of once-daily icotrokinra or a placebo. The proportion of patients achieving an overall Investigator’s Global Assessment score of 0 (complete clearance) or 1 (almost clear) reached 57% for the active treatment group compared to 6% for the placebo arm.

Following the initial 16 weeks, participants originally assigned to the placebo group crossed over to receive icotrokinra. By week 112, response rates converged across both cohorts as delayed responders caught up. An overall Investigator’s Global Assessment score of 0 or 1 was maintained by 70% of those initially randomized to icotrokinra and 64% of those who crossed over from placebo. Complete skin clearance, represented by a score of 0, was achieved by 48% of patients in both groups at the 112-week mark.

Anatomical Target	Assessment Measure	Initial Icotrokinra (Week 16)	Initial Icotrokinra (Week 112)	Placebo Crossover (Week 112)
Scalp	ss-IGA 0 or 1	66%	74%	77%
Genitals	sPGA-G 0 or 1	77%	89%	92%
Hands and Feet	hf-PGA 0 or 1	42%	68%	66%
Nails	mNAPSI Improvement	33%	71%	74%

Durable Responses Across Scalp, Genital, and Nail Endpoints

Anatomical subsite analysis revealed distinct response trajectories depending on the physical location of the psoriatic plaques. Scalp and genital psoriasis demonstrated rapid improvement, with peak response rates established by week 24 and sustained without functional decline through week 112. For scalp-specific evaluations, the proportion of patients with an ss-IGA score of 0 or 1 reached 74% at week 112 in the continuous treatment arm and 77% in the crossover arm.

Genital psoriasis showed particularly high clearance rates. Among patients with genital involvement, the sPGA-G score of 0 or 1 climbed from 77% at week 16 to 89% at week 112 in the continuous icotrokinra arm, and jumped from 21% to 93% among patients who crossed over from placebo. Complete genital clearance at week 112 was documented in 89% of the primary treatment group and 92% of the crossover group.

Hands and feet presented a slower clinical timeline, with peak responses delayed until week 52 before stabilizing through week 112. Nail psoriasis, measured via the modified Nail Psoriasis Severity Index, required extended therapeutic runway. Average percentage improvements in mNAPSI scores reached 33% at week 16 for the active drug, advancing to 71% by week 112 for continuous users and 74% for crossover patients. Complete clearance of nail disease was ultimately achieved by 42% of the primary cohort and 54% of the crossover cohort at the conclusion of the 112-week study.

FDA and EMA Authorize Icotyde for Patients

The 2-year data extension builds directly upon earlier phase 3 findings from the ICONIC-ADVANCE 1 and 2 trials. These foundational studies secured regulatory approvals for icotrokinra under the brand name Icotyde, achieving authorization from the United States Food and Drug Administration in March and the European Medicines Agency in September for patients aged 12 years and older.

Safety analyses from the ICONIC-TOTAL trial demonstrated that adverse event frequencies remained consistent between icotrokinra and placebo cohorts during the initial 16-week blinded window. Serious adverse events occurred at a numerically lower rate in the active treatment group compared to placebo at less than 1% versus 2%, respectively. Long-term follow-up through week 112 revealed no emerging signals regarding overall toxicity or immune function-related complications, such as infections.

References

• European Academy of Dermatology and Venereology (EADV) 2026 Congress: ICONIC-TOTAL Trial Presentation by Richard B. Warren.
• ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 Phase 3 Clinical Trials.
• United States Food and Drug Administration (FDA) Drug Approval Database (March).
• European Medicines Agency (EMA) Authorizations (September).