ICONIC-LEAD in Plaque Psoriasis

Photo Credit: Tumeyes

New findings from the phase 3 ICONIC-LEAD trial suggest that once-daily oral icotrokinra demonstrated significant, durable skin clearance and a safety profile similar to placebo in patients with plaque psoriasis.

Icotrokinra is a first-in-class, targeted oral peptide that selectively binds the IL-23 receptor and inhibits signaling. The placebo-controlled, double-blind ICONIC-LEAD trial (NCT06095115), presented by Robert Bissonnette, MD, FRCPC, MSc, Innovaderm Research, Montreal, Quebec, Canada, enrolled 684 participants aged 12 years and older across 170 global sites.¹ Participants with moderate-to-severe plaque psoriasis were randomized 2:1 to receive 200 mg icotrokinra through week 24 or placebo through week 16 followed by transition crossover to 200 mg icotrokinra. Co-primary end points were an Investigator Global Assessment (IGA) score of 0 or 1 and Psoriasis Area and Severity Index (PASI) 90 responses at week 16.

The co-primary end points were both met. At week 16, 65% of the icotrokinra group achieved an IGA0/1 (ie, clear [0]/almost clear [1] skin and ≥2-grade improvement from baseline), compared with 8% of the placebo group (P<0.001). PASI90 response rates were 50% for icotrokinra versus 4% for placebo (P<0.001). By week 24, 74% achieved an IGA score of 0 or 1, 65% reached PASI90, 46% achieved complete skin clearance (IGA 0), and 40% attained PASI100. Adverse event rates were similar between groups (49%), with no new safety concerns reported.

Dr. Bissonnette concluded, “Icotrokinra demonstrated significantly higher rates of skin clearance and a favorable safety profile in adults and adolescents with moderate-to-severe plaque psoriasis.”

Medical writing support was provided by Dr. Rachel Giles.
Copyright ©2025 Medicom Medical Publishers