Characterised by the overproduction of skin cells, plaque psoriasis leads to itchy or painful inflamed and scaly plaques. Credit: And-One / Shutterstock.

Johnson & Johnson (J&J) has reported positive topline outcomes from its Phase III ICONIC-LEAD trial of oral icotrokinra (JNJ-2113) for treating moderate to severe plaque psoriasis in patients aged 12 years and older.

Around 64.7% of subjects who were given icotrokinra in the study achieved clear or almost clear skin (IGA scores of 0/1) after 16 weeks.

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In addition, 49.6% of patients had achieved a Psoriasis Area and Severity Index (PASI) 90 response by week 16, significantly outperforming the placebo group.

By week 24, the response rates improved further, with 74.1% achieving IGA 0/1 scores and 64.9% reaching PASI 90.

The trial met its co-primary endpoints at week 16, with significant skin clearance observed in the icotrokinra group compared to subjects given placebo.

Its safety data was in line with findings from earlier studies, while the proportion of patients who had experienced treatment-emergent adverse events was similar between the icotrokinra and placebo arms, at 49.3% and 49.1% respectively, at week 16.

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The Phase III ICONIC-TOTAL trial also reported positive topline outcomes, with icotrokinra meeting the primary endpoint of IGA 0/1 at week 16 against placebo.

Johnson & Johnson Innovative Medicine Immunodermatology Disease area lead and vice-president Liza O’Dowd said: “We are excited to see impressive Phase III results with once-daily icotrokinra treatment aligned with our Phase II study of this first-in-class targeted oral peptide that selectively blocks the IL-23 receptor.

“The majority of people living with moderate-to-severe plaque psoriasis are eligible for, but are still not receiving, advanced therapies.

“Icotrokinra has the potential to offer once-daily oral therapy that could help address the needs and preferences of people living with plaque psoriasis.”

Plaque psoriasis is a chronic immune-mediated disease characterised by the overproduction of skin cells. It leads to itchy or painful inflamed and scaly plaques.

J&J recently reported outcomes from the Phase II DAHLIAS study of nipocalimab for treating moderate-to-severe Sjögren’s disease.