ICONIC-LEAD: Icotrokinra Sustains Psoriasis Skin Clearance at 2 Years

Icotrokinra (Icotyde), a targeted oral peptide blocking the interleukin-23 (IL-23) receptor, sustained high rates of skin clearance and itch improvement through 2 years in adults and adolescents with moderate-to-severe plaque psoriasis, according to new long-term data from the phase 3 ICONIC-LEAD study. The Week 112 results were presented at the 2026 Fall Clinical Dermatology Conference in Las Vegas and announced by Johnson & Johnson on October 9, 2026.

Icotrokinra is approved in the US for moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy. It is also approved in Europe, Japan, and China and is taken as a single 200-mg pill once daily upon waking, on an empty stomach, at least 30 minutes before eating.

The new findings add to previously reported 2-year ICONIC-TOTAL data, which showed sustained clearance in scalp, genital, hand and foot, and nail psoriasis.

What Did 2-Year ICONIC-LEAD Data Show for Icotrokinra?

ICONIC-LEAD (NCT06095115) is a randomized, placebo-controlled phase 3 trial evaluating icotrokinra in 684 participants aged 12 years and older with moderate-to-severe plaque psoriasis, including 66 adolescents. Participants were randomized to icotrokinra (n = 456) or placebo (n = 228). The co-primary endpoints were Psoriasis Area and Severity Index (PASI) 90 and an Investigator’s Global Assessment (IGA) score of 0 or 1 with at least a 2-grade improvement.

From Week 64 through Week 112, at least 72% of icotrokinra-treated patients achieved PASI 90 and at least 70% achieved clear or almost clear skin (IGA 0/1), according to the company. Complete skin clearance was also sustained across the same period, with at least 44% of patients reaching PASI 100 and at least 46% achieving IGA 0.

Patient-reported outcomes followed a similar pattern. Clinically meaningful improvement in itch was maintained in 78% of patients from Week 64 to Week 112.

How Did Patients Respond to Withdrawal and Retreatment?

The study also evaluated a randomized withdrawal and retreatment period among Week 24 responders. Among PASI 90 responders withdrawn from icotrokinra at Week 24, 85% regained a PASI 90 response within 24 weeks of retreatment. Withdrawal and retreatment responses were also captured among PASI 75 and IGA 0/1 responders at Week 24, although the company did not report those results in its announcement.

Safety findings through Week 112 remained consistent with the established profile of icotrokinra, and no new safety signals were identified. Per prescribing information, the most common adverse effects include headache, nausea, cough, fungal infection, and fatigue.

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, emphasized durability as an essential consideration in therapy selection for a chronic, lifelong disease such as plaque psoriasis. He noted the 2-year data support icotrokinra as a first-line systemic option for both adult and adolescent patients. Lebwohl is a paid consultant for Johnson & Johnson.

David M. Lee, MD, PhD, global immunology therapeutic area head at Johnson & Johnson, highlighted long-term management as a central need in plaque psoriasis care, given the chronic nature of the disease.

Beyond ICONIC-LEAD and ICONIC-TOTAL, the ICONIC program includes the ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 trials comparing icotrokinra with placebo and deucravacitinib. Icotrokinra is also under investigation in psoriatic arthritis, ulcerative colitis, and Crohn disease.

Editor’s note: This summary has been edited for grammar and clarity using artificial intelligence tools.

References

1. Johnson & Johnson. New Johnson & Johnson ICOTYDE (icotrokinra) long-term data demonstrate robust 2-year results in the treatment of adults and adolescents with plaque psoriasis. Published 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. Bissonnette R, et al. Durability of clinical response, participant-reported outcomes, and safety through 2 years with icotrokinra in adults and adolescents with moderate-to-severe plaque psoriasis: results from the phase 3 ICONIC-LEAD study. Poster presented at: 2026 Fall Clinical Dermatology Conference; October 8-11, 2026; Las Vegas, NV.