Icotrokinra Maintains Skin Clearance Through 2 Years in Phase 3 ICONIC-LEAD

At least 72% of patients with moderate to severe plaque psoriasis treated with icotrokinra (Icotyde; Johnson & Johnson) achieved PASI 90 from week 64 through week 112 of the phase 3 ICONIC-LEAD trial (NCT06095115), according to a poster presented at the 2026 Fall Clinical Dermatology Conference in Las Vegas, Nevada.¹ At least 70% of participants achieved an Investigator’s Global Assessment (IGA) score of 0/1 over the same period.

Data also indicated that complete clearance held. At least 44% of patients achieved PASI 100 and at le

ast 46% achieved an IGA score of 0 from week 64 through week 112. Clinically meaningful itch improvement was sustained in 78% of patients.

ICONIC-LEAD randomly assigned 684 participants aged 12 years and older to icotrokinra (n = 456) or placebo (n = 228), including 66 adolescents. The coprimary end points were PASI 90 and an IGA score of 0/1 with at least a 2-grade improvement.

“As plaque psoriasis is a chronic lifelong disease, durable results are essential in therapy selection,” Mark Lebwohl, MD, professor and chair emeritus of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai and an ICONIC-LEAD investigator, commented in a news release. “With two-year data that show long-term skin clearance and a consistent safety profile, Icotyde is transforming how we think about plaque psoriasis treatment.”¹

Retreatment Response and Safety Through Week 112
Among PASI 90 responders who were withdrawn from icotrokinra at week 24, 85% regained PASI 90 within 24 weeks of retreatment.¹ The trial was designed to capture withdrawal and retreatment responses among patients who had responded at week 24.

Safety findings through week 112 were consistent with the drug’s established profile, with no new safety signals identified. Although the announcement did not include adverse event rates, the most common adverse effects listed in the prescribing information are headache, nausea, cough, fungal infection, and fatigue.

High-Impact Sites and Head-to-Head Trials

The results follow 2-year data from the phase 3 ICONIC-TOTAL trial presented last week at the 2026 European Academy of Dermatology and Venereology Congress.² According to those data, 70% of patients with psoriasis involving high-impact sites had an IGA score of 0/1 at week 112, which was up from 57% at week 16. Complete site-specific clearance was reported in 60% of patients with scalp involvement, 89% with genital involvement, and 63% with hand and/or foot involvement. Nail disease also continued to improve, with mean improvement on the modified Nail Psoriasis Severity Index rising from 33% at week 16 to 71% at week 112.

Comparative studies round out the program. ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) were designed to evaluate icotrokinra against placebo and deucravacitinib in adults, and ICONIC-ASCEND (NCT06934226) is comparing it with placebo and ustekinumab. Studies in psoriatic arthritis, ulcerative colitis, and Crohn disease are ongoing.¹

Icotrokinra in Clinical Practice

“I’m excited to have this practice-changing targeted oral peptide as a first-line systemic therapy for both my adult and adolescent patients,” Lebwohl said in a statement to the press.¹

Icotrokinra, a once-daily oral peptide that blocks the interleukin-23 receptor, was approved by the FDA in March 2026 for moderate to severe plaque psoriasis in adults and adolescents aged 12 years and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy.³ The 200-mg tablet is taken on waking with water on an empty stomach, at least 30 minutes before eating. For patients who have difficulty swallowing tablets, it can be dispersed in water. The drug is also approved in Europe, Japan, and China.

References

1. New Johnson & Johnson Icotyde (icotrokinra) long-term data demonstrate robust 2-year results in the treatment of adults and adolescents with plaque psoriasis. News release. Johnson & Johnson. October 9, 2026. Accessed October 9, 2026. https://www.jnj.com/media-center/press-releases/new-johnson-johnson-icotyde-icotrokinra-long-term-data-demonstrate-robust-2-year-results-in-the-treatment-of-adults-and-adolescents-with-plaque-psoriasis
2. Duerr HA. Icotrokinra sustains skin clearance at high-impact psoriasis sites through 2 years. Dermatology Times. October 2, 2026. Accessed October 9, 2026. https://www.dermatologytimes.com/view/icotrokinra-sustains-skin-clearance-at-high-impact-psoriasis-sites-through-2-years
3. Hebebrand M. FDA approves icotrokinra, first oral IL-23 receptor blocker for psoriasis. Dermatology Times. March 18, 2026. Accessed October 9, 2026. https://www.dermatologytimes.com/view/fda-approves-ictrokinra-first-oral-il-23-receptor-blocker-for-psoriasis