ICOTYDE Sustains PASI 90 Response Through Two Years

Johnson & Johnson has reported two-year results from the Phase 3 ICONIC-LEAD study evaluating ICOTYDE® (icotrokinra) in adults and adolescents aged 12 years and older with moderate-to-severe plaque psoriasis. Presented at Fall Clinical Dermatology 2026, the findings showed sustained skin clearance and patient-reported symptom improvement through Week 112, with no new safety signals identified.

Nearly Three-Quarters of Patients Maintain High Levels of Skin Clearance

In ICONIC-LEAD, at least 72% of ICOTYDE-treated patients achieved a 90% improvement in the Psoriasis Area and Severity Index (PASI 90), while at least 70% achieved clear or almost clear skin according to the Investigator’s Global Assessment (IGA 0/1) from Week 64 through Week 112.

Complete skin clearance was also sustained during this period. At least 44% of patients achieved PASI 100, representing a 100% improvement in PASI score from baseline, while at least 46% achieved an IGA score of 0, indicating clear skin.

These findings demonstrate sustained treatment responses over approximately two years. PASI 90 measures substantial improvement in psoriasis severity, while IGA 0/1 captures the proportion of patients whose skin is assessed as clear or almost clear. The results provide additional evidence on the durability of response during long-term treatment.

Sustained Itch Improvement and Response After Retreatment

Beyond visible skin clearance, ICOTYDE demonstrated sustained improvement in itching, a symptom that can affect daily activities and quality of life in people with psoriasis.

Clinically meaningful itch improvement was maintained in 78% of patients from Week 64 through Week 112, according to the reported results.

The study also assessed treatment withdrawal and subsequent retreatment. Among patients who had achieved a PASI 90 response and were withdrawn from ICOTYDE at Week 24, 85% regained PASI 90 within 24 weeks of restarting treatment.

This finding provides information about the recovery of treatment response following interruption. It should not be interpreted as evidence that routine treatment discontinuation is appropriate for all patients.

Targeted Oral Peptide Blocks IL-23 Receptor Signalling

ICOTYDE (icotrokinra) is a targeted oral peptide designed to selectively block the interleukin-23 (IL-23) receptor, which plays a central role in immune signalling associated with plaque psoriasis. Johnson & Johnson describes it as the first and only targeted oral peptide designed to block this receptor.

Unlike injectable biologic therapies targeting components of the IL-23 pathway, ICOTYDE offers an oral treatment option. Under US prescribing instructions, the medicine is taken once daily upon waking with water on an empty stomach, at least 30 minutes before eating.

ICONIC-LEAD enrolled 684 participants aged 12 years and older, including 66 adolescents. The randomised Phase 3 study compared ICOTYDE with placebo, with 456 participants assigned to ICOTYDE and 228 to placebo. PASI 90 and IGA 0/1 with at least a two-grade improvement were the co-primary endpoints.

The wider ICONIC clinical development programme also includes ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, which compare ICOTYDE with placebo and deucravacitinib, an oral TYK2 inhibitor, in adults with moderate-to-severe plaque psoriasis. These separate studies will provide additional comparative evidence.

Two-Year Safety Findings Remain Consistent

Safety findings through Week 112 remained consistent with the established safety profile of ICOTYDE, with no new safety signals identified in the reported analysis.

This finding is relevant for a treatment intended for a chronic condition that may require prolonged disease management. However, the absence of new safety signals does not mean that treatment is free of risks. The two-year announcement does not, by itself, establish the frequency of individual adverse effects or replace the medicine’s prescribing information.

Healthcare professionals should consult the current official product information for the relevant jurisdiction when assessing contraindications, warnings, precautions and monitoring requirements.

Johnson & Johnson Advances ICOTYDE Across Immune-Mediated Diseases

ICOTYDE was jointly discovered and is being developed under a licensing and collaboration agreement between Protagonist Therapeutics and Johnson & Johnson. Johnson & Johnson holds exclusive worldwide rights to develop the candidate in Phase 2 and later clinical trials and to commercialise compounds arising from the collaboration across a broad range of indications.

Beyond plaque psoriasis, the company is investigating icotrokinra in active psoriatic arthritis, ulcerative colitis and Crohn’s disease. These remain separate investigational programmes, and the psoriasis findings do not establish efficacy in those conditions.

In the United States, ICOTYDE is approved 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. The medicine is also approved in Europe, Japan and China for psoriasis in adults and adolescents, although local indications and prescribing instructions may differ.

The two-year ICONIC-LEAD findings add to the clinical evidence for ICOTYDE, with sustained skin clearance, continued itch improvement and no newly identified safety signals through Week 112. Further comparative and long-term data will help clarify its role in the management of plaque psoriasis.

Reference

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. October 9, 2026

A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis (ICONIC-LEAD), ClinicalTrials.gov ID NCT06095115