Johnson & Johnson (J&J) and Protagonist Therapeutics’ icotrokinra has outperformed BMS’s Sotyktu (deucravacitinib) in treating patients with moderate-to-severe plaque psoriasis.
In the Phase III ICONIC-ADVANCE 1 and 2 studies (NCT06143878 and NCT06220604) the oral IL-23 therapy showed superior skin clearance compared to Sotyktu at both weeks 16 and 24.
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There was a significantly higher proportion of Investigator’s Global Assessment (IGA) of clear (0) and almost clear (1) achieved in icotrokinra at week 16, with 68% and 70% compared with 50% and 54% in Sotyktu patients in ADVANCE 1 and ADVANCE 2, respectively. This benefit was even larger after 24 weeks with 74% and 68% of patients on the study drug compared to 52% and 55% with BMS’s therapy.
On the Psoriasis Area and Severity Index 90 (PASI90) scale, after 16 weeks, this was achieved by 55% and 57% of patients treated with icotrokinra versus 30% and 34% who received Sotyktu. At the 24-week mark, 66% and 65% of icotrokinra patients achieved this compared to 41% and 43% of patients who were treated with Sotyktu.
Icotrokinra demonstrated significantly higher rates of completely clear skin vs Sotyktu after 16 weeks, with a PASI100 score of 31% and 32% vs 11% and 14%. These effects were maintained through to 24 weeks of treatment.
The detailed data was presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France.
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By GlobalDataDr Linda Stein Gold, Director of Dermatology Clinical Research at Henry Ford Health and ICONIC-ADVANCE study investigator, said: “These head-to-head data clearly demonstrate superior complete skin clearance rates for icotrokinra compared to Sotyktu. 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.”
The company is also pitting the oral therapy against its own injectable biologic Stelara (ustekinumab) in the Phase III ICONIC-ASCEND trial in patients with plaque psoriasis.
J&J submitted a new drug application (NDA) seeking approval from the US Food and Drug Administration (FDA) for icotrokinra in moderate to severe plaque psoriasis in July 2025.
52-week icotrokinra data also presented at EADV
The companies also presented 52-week data from the Phase III ICONIC-LEAD study (NCT06095115) investigating icotrokinra in adults and paediatric patients 12 years of age and older with moderate-to-severe plaque psoriasis.
Adult icotrokinra PASI 90 responders re-randomised to icotrokinra after 24 weeks achieved a superior maintenance of PASI 90 response versus those re-randomised to placebo – 84% vs 21%.
Also, after one year, 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.
GlobalData analysts believe that icotrokinra will do well on the market, predicting that even with a projected 2026 approval, it will achieve blockbuster status in 2029, before hitting global sales of $3.25bn in 2031.
GlobalData is the parent company of Clinical Trials Arena.
