Icotrokinra, an investigational oral interleukin (IL)-23 blocker, bested deucravacitinib (Sotyktu, BMS) in efficacy and safety, according to the first reported head-to-head trials.
These data were presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, France.
In the ICONIC-ADVANCE 1 and 2 trials, icotrokinra showed superior skin clearance vs. placebo (Week 16) and deucravacitinib (Weeks 16 and 24). Moreover, icotrokinra demonstrated similar adverse event rates (AEs) to placebo, with no new safety signals identified. Icotrokinra AE rates were numerically lower vs deucravacitinib through Week 24, the researchers report.
“These head-to-head data clearly demonstrate superior complete skin clearance rates for icotrokinra compared to deucravacitinib,” says Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health in Detroit, MI, and ICONIC-ADVANCE study investigator, in a news release. “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.”
New Long-term Data From the Phase 3 ICONIC-LEAD
In related news also presented at the EADV Conference, the ICONIC-LEAD trial demonstrated icotrokinra’s sustained efficacy and favorable safety profile over one year in adults and adolescents with psoriasis.
At Week 52, Adult icotrokinra Psoriasis Area and Severity Index (PASI) 90 responders re-randomized to icotrokinra at Week 24 had superior maintenance of PASI 90 response vs. those re-randomized to placebo (84% vs 21%).
At Week 52, 86% of adolescents who received icotrokinra for the full 52 weeks and 77% of those switched from placebo to icotrokinra at Week 16 achieved PASI 90 response, the study showed.
ICONIC-LEAD Week 16 primary endpoint data were previously presented at the American Academy of Dermatology 2025 Congress.
“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,” says Jennifer Soung, MD, Director of Clinical Research at Southern California Dermatology in Los Angeles, CA, and ICONIC-LEAD study investigator. “With a substantial proportion of adults and adolescents achieving Clear or Almost Clear skin while maintaining a favorable 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.”
About Icotrokinra
Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.
The company recently submitted an application to the European Medicines Agency (EMA) for what could be the first-ever approval of icotrokinra for the treatment of moderate-to-severe plaque psoriasis in people aged 12 and up. It has also initiated the Phase 3 ICONIC-ASCEND study, the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab, in psoriasis.
