Johnson & Johnson reported two-year results from its Phase 3 ICONIC-LEAD study showing sustained skin clearance and symptom improvement with Icotyde, or icotrokinra, in adults and adolescents with moderate-to-severe plaque psoriasis.
The results, presented at Fall Clinical Dermatology 2026, covered follow-up through week 112. Icotyde is an oral peptide that blocks the interleukin-23 receptor.
From week 64 through week 112, at least 72% of treated patients achieved PASI 90, indicating a 90% improvement from baseline on the Psoriasis Area and Severity Index. At least 70% had clear or almost clear skin on the Investigator’s Global Assessment.
Complete skin clearance was also maintained over that period. At least 44% achieved PASI 100, representing a 100% improvement from baseline, while at least 46% received an investigator assessment of clear skin.
Clinically meaningful improvement in itch was sustained in 78% of patients from week 64 to week 112.
Among PASI 90 responders whose treatment was withdrawn at week 24, 85% regained that response within 24 weeks of restarting Icotyde.
Safety findings through week 112 remained consistent with the drug’s established profile, with no new safety signals identified, the company said.
ICONIC-LEAD randomized 684 participants aged 12 and older, including 66 adolescents. The study assigned 456 participants to Icotyde and 228 to placebo.
Its co-primary endpoints were PASI 90 and clear or almost clear skin with at least a two-grade improvement on the investigator assessment.
The broader ICONIC program includes studies evaluating icotrokinra in psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease, according to Johnson & Johnson.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!