ICONIC-LEAD phase III: Icotrokinra in adolescent subgroup with moderate-to-severe plaque psoriasis

During the American College of Rheumatology (ACR) Convergence 2025, October 24–29, 2025, Chicago, US, Joseph Merola presented findings from the subgroup analyses of the phase III ICONIC-LEAD trial (NCT06095115), evaluating the efficacy and safety of icotrokinra, a targeted oral peptide, vs placebo in adolescent patients aged between 12 and <18 years with moderate-to-severe plaque psoriasis (PsO) (N = 66). Patients were randomized 2:1 to receive once-daily icotrokinra 200 mg (n = 44) or placebo (n = 22) to Week 16. Patients in the placebo group crossed over to icotrokinra from Week 16. This analysis assessed the Psoriasis Area and Severity Index (PASI) and Investigator’s Global Assessment (IGA) responses from Week 16 to Week 24.

Key data: At Week 16, a higher proportion of adolescent patients receiving icotrokinra achieved IGA 0/1 (84.1% vs 27.3%; p < 0.001) and PASI 90 (70.5% vs 13.6%; p < 0.001) compared with those receiving placebo; responses with icotrokinra were sustained at Week 24 (IGA 0/1, 86.4%; PASI 90, 88.6%). At Week 24, 75.0% and 63.6% of patients achieved IGA 0 and PASI 100, respectively. Icotrokinra demonstrated a favorable safety profile through Week 16, with no new safety signals identified.

Key learning: Icotrokinra treatment demonstrates higher rates of clear or almost clear skin through Week 16 compared with placebo, with sustained responses at Week 24, in adolescent patients with moderate-to-severe plaque PsO, complementing results from the overall study population.