2-Year ICONIC-LEAD Data Show Sustained Psoriasis Responses With Oral Icotrokinra
Key Takeaways
- Week 112 ICONIC-LEAD results showed sustained skin clearance with oral icotrokinra in adults and adolescents with moderate-to-severe plaque psoriasis.
- At least 72% achieved PASI 90 and at least 70% achieved IGA 0/1 during Weeks 64–112, according to Johnson & Johnson.
- The company reported no new safety signals through Week 112; detailed long-term safety and analysis denominators were not provided in the supplied release.
Two-year findings from the Phase 3 ICONIC-LEAD trial showed sustained skin clearance and itch improvement with icotrokinra (ICOTYDE; Johnson & Johnson) in adults and adolescents aged 12 years or older with moderate-to-severe plaque psoriasis, according to data presented at the 2026 Fall Clinical Dermatology Conference.1
ICONIC-LEAD (NCT06095115) initially randomized 684 participants, including 66 adolescents, to icotrokinra (n = 456) or placebo (n = 228). The trial’s co-primary endpoints were achievement of at least 90% improvement in 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.¹
Skin Clearance and Retreatment Outcomes Through Week 112
From Week 64 through Week 112, at least 72% of icotrokinra-treated patients achieved PASI 90, and at least 70% had clear or almost clear skin (IGA 0/1), the company reported. At least 44% achieved PASI 100, while at least 46% had an IGA score of 0. Clinically meaningful itch improvement was sustained in 78% of patients over the same interval.
Among PASI 90 responders withdrawn from treatment at Week 24, 85% regained PASI 90 within 24 weeks after restarting icotrokinra. Johnson & Johnson reported no new safety signals through Week 112 and said the findings were consistent with the drug’s established safety profile.
“As plaque psoriasis is a chronic lifelong disease, durable results are essential in therapy selection,” said Mark Lebwohl, MD, professor and chair emeritus of dermatology at the Icahn School of Medicine at Mount Sinai and an ICONIC-LEAD investigator.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. 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