Johnson & Johnson has reported new data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies showing that icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, demonstrated superior skin clearance compared to deucravacitinib and similar adverse event rates to placebo in adults with moderate-to-severe plaque psoriasis. The findings were presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress.

In ICONIC-ADVANCE 1 and 2, icotrokinra met both co-primary endpoints (IGA 0/1 and PASI 90) versus placebo at Week 16, with comparable safety. The studies also showed superiority over deucravacitinib at Weeks 16 and 24:

• Week 16: IGA 0/1 68/70% vs 11/9% (placebo); PASI 90 55/57% vs 4/1%

• Week 16 complete clearance vs deucravacitinib: IGA 0 37/37% vs 16/17%; PASI 100 31/32% vs 11/14%

• Week 24: Skin clearance rates were at least two-fold higher than at Week 16

• Adverse event rates were similar to placebo and numerically lower than deucravacitinib

“These head-to-head data clearly demonstrate superior complete skin clearance rates for icotrokinra compared to deucravacitinib,” said Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health and ICONIC-ADVANCE study investigator. “With significantly higher response rates seen as early as Week 16 and increasing at Week 24, this novel targeted oral peptide treatment has the potential to be an appealing new option for patients with moderate-to-severe plaque psoriasis.”

Long-term data from the Phase 3 ICONIC-LEAD study, presented as a late-breaking abstract at EADV, showed sustained skin clearance and a similar safety profile relative to placebo through Week 52 in adults and adolescents (12 years and older):

• Adults: PASI 90 maintenance at Week 52 was 84% for patients re-randomised to icotrokinra versus 21% for placebo (p<0.001)

• Adolescents: PASI 90 achieved by 86% of those on icotrokinra for 52 weeks and 77% who switched from placebo at Week 16

“The long-term data from ICONIC-LEAD continue to demonstrate the potential of icotrokinra to address the need for a novel targeted oral psoriasis treatment,” said Jennifer Soung, MD, director of clinical research at Southern California Dermatology and ICONIC-LEAD study investigator. “With a substantial proportion of adults and adolescents achieving clear or almost clear skin while maintaining a favourable safety profile through 52 weeks, icotrokinra could be a compelling new therapeutic option that aligns with both patient and provider goals for an oral treatment once approved.”

Liza O’Dowd, MD, vice president, immunodermatology lead, Johnson & Johnson Innovative Medicine, added: “We’re excited to see the icotrokinra Phase 3 ICONIC programme continue to deliver robust and clinically meaningful head-to-head and long-term results.”

Dr Mark Graham, therapeutic area head, immunology, Johnson & Johnson Innovative Medicine EMEA, said: “Those living with psoriasis face many challenges beyond the physical manifestations. The latest results from our ICONIC clinical development programme demonstrate our commitment to continue driving new treatment options for patients so they can achieve better health outcomes and an improved quality of life.”