ICOTYDE long-term data demonstrate robust 2-year results in the treatment of adults and adolescents with plaque psoriasis – Johnson & Johnson
Johnson & Johnson announced new two-year results from the Phase 3 ICONIC-LEAD study evaluating ICOTYDE (icotrokinra), the first and only targeted oral peptide that precisely blocks the IL-23 receptor, in adults and pediatric patients 12 years of age and older (adolescents) with moderate-to-severe plaque psoriasis.
These data, presented at Fall Clinical Dermatology (FCD) 2026, demonstrated consistently high levels of skin clearance and patient-reported symptom improvement at Week 112, with no new safety signals identified.
“As plaque psoriasis is a chronic lifelong disease, durable results are essential in therapy selection. 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,” said Mark Lebwohl, M.D., Professor and Chair Emeritus, Department of Dermatology, Icahn School of Medicine at Mount Sinai and ICONIC-LEAD study investigator. “I’m excited to have this practice-changing targeted oral peptide as a first-line systemic therapy for both my adult and adolescent patients.”
ICOTYDE clinical data highlights:
i) High levels of skin clearance were observed at Week 112, with ≥72% of ICOTYDE-treated patients achieving a Psoriasis Area and Severity Index score (PASI) of 90 and ≥70% achieving clear or almost clear skin (Investigator’s Global Assessment [IGA] 0/1d) from Week 64 through Week 112.
ii) Complete skin clearance was sustained from Week 64 through Week 112, with ≥44% of ICOTYDE-treated patients achieving PASI 100 and ≥46% achieving IGA 0 (clear skin).
iii) Clinically meaningful improvement in itch was sustained in 78% of patients from Week 64 to Week 112.
iv) Among PASI 90 responders who were withdrawn from ICOTYDE at Week 24, 85% regained PASI 90 response within 24 weeks of retreatment.
v) Safety findings through Week 112 remained consistent with the established safety profile of ICOTYDE, with no new safety signals identified.
“These long-term results affirm that ICOTYDE, as the first and only targeted oral peptide, represents a groundbreaking shift in the treatment of plaque psoriasis,” said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. “Due to the chronic nature of the disease, long-term management is key, and ICOTYDE is delivering on the promise of transformational innovation to meet the needs of patients.”
About the ICONIC clinical development program
The pivotal Phase 3 ICONIC clinical development program includes four studies of ICOTYDE in patients with moderate-to severe plaque PsO.
• ICONIC-LEAD (NCT06095115) is a RCT to evaluate the efficacy and safety of ICOTYDE compared with placebo in participants with moderate-to-severe plaque PsO, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary.
• ICONIC-TOTAL (NCT06095102) is a RCT to evaluate the efficacy and safety of ICOTYDE compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint.
• ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) are RCTs to evaluate the efficacy and safety of ICOTYDE compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.
