N Engl J Med

Targeted oral peptide shows high efficacy in plaque psoriasis treatment

November 7, 2025

Study details: The phase 3, double-blind, placebo-controlled ICONIC-LEAD trial (NCT06095115) evaluated icotrokinra, a first-in-class oral IL-23 receptor inhibitor, in 684 patients aged ≥12 years with moderate-to-severe plaque psoriasis. Participants were randomized 2:1 to receive icotrokinra 200 mg daily or placebo. Co-primary endpoints: Investigator's Global Assessment (IGA) 0/1 and Psoriasis Area and Severity Index (PASI) 90 responses at week 16.

Results: At week 16, 65% of icotrokinra-treated patients achieved IGA 0/1 vs. 8% with placebo; PASI 90 was reached by 50% vs. 4%, respectively (P<0.001). Complete clearance (IGA 0 and PASI 100) was significantly higher with icotrokinra (33% and 27%) than placebo (<1%). The percentage of participants with ≥1 adverse event through week 16 was 49% in each group; the most common adverse events in each group were nasopharyngitis and upper respiratory tract infection.

Clinical impact: Icotrokinra represents a promising oral alternative to injectable biologics, with comparable efficacy and favorable safety profile, potentially expanding treatment options for both adult and adolescent patients with moderate-to-severe plaque psoriasis.

Source:

Bissonnette R, et al. (2025, November 6). N Engl J Med. Oral Icotrokinra for Plaque Psoriasis in Adults and Adolescents. https://pubmed.ncbi.nlm.nih.gov/41191940/