Phase III ICONIC-ADVANCE 1 and 2 trials: Icotrokinra in moderate-to-severe plaque PsO

Results from 1 year of the phase III, randomized, placebo- and active comparator-controlled ICONIC-ADVANCE 1 (NCT06143878; n = 774) and ICONIC-ADVANCE 2 (NCT06220604; n = 731) trials, evaluating icotrokinra in patients with moderate-to-severe plaque psoriasis (PsO), were published in the British Journal of Dermatology by Stein Gold et al. The co-primary endpoints in both studies were the proportions of patients achieving an Investigator’s Global Assessment score of 0/1 (IGA 0/1) and ≥90% improvement in Psoriasis Area and Severity Index (PASI90) at Week 16. 

Key data: At Week 16, a significantly greater proportion of patients receiving icotrokinra vs placebo achieved IGA 0/1 (ADVANCE 1, 68% vs 11%; p < 0.001; ADVANCE 2, 71% vs 9%; p < 0.001), PASI90 (ADVANCE 1, 55% vs 4%; p < 0.001; ADVANCE 2, 58% vs 1%; p < 0.001), and scalp-specific (SS)-IGA 0/1 (ADVANCE 1, 72% vs 21%; p < 0.001; ADVANCE 2, 74% vs 19%; p < 0.001). IGA 0/1 responses were maintained or increased by Week 24 (ADVANCE 1, 74%; ADVANCE 2, 69%) and were durable through Week 52 (ADVANCE 1, 74%; ADVANCE 2, 73%); at Week 52, IGA 0/1 and PASI90 responses were maintained in 88% and 90% of patients, respectively, in ADVANCE 1 and in 84% and 87% of patients, respectively, in ADVANCE 2. Patients who transitioned from placebo or deucravacitinib to icotrokinra achieved comparable response rates by Week 52. No new safety signals were observed through Week 52. 

Key learning: Icotrokinra achieved durable skin clearance with no new safety signals through Week 52, supporting its potential as a systemic treatment option for sustained disease control in adults with moderate-to-severe plaque PsO.