Icotrokinra, Plaque Psoriasis, and ICONIC-LEAD, with Robert Bissonnette, MD

New data from the ICONIC-LEAD trial suggest icotrokinra could soon a major role in dermatology’s armamentarium for the management of plaque psoriasis.

Presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, results of the phase 3 study demonstrate the benefit of icotrokinra among adults with moderate to severe plaque psoriasis.

“These study results are promising, showing the potential for icotrokinra to offer patients the unique combination of complete skin clearance and a favorable safety profile in a once-daily pill,” said principal investigator Robert Bissonnette, MD, chairman at Innovaderm Research, Montreal, Canada, who presented the ICNONIC-LEAD data at AAD 2025.

The ICONIC-LEAD trial, a multicenter, randomized, double-blind, placebo-controlled study, enrolled 684 participants aged 12 years and older at 170 sites globally. Participants were randomized 2:1 to icotrokinra or placebo, with the study primarily assessing IGA scores and PASI 90 responses.

Results of the placebo-controlled, double-blind, randomized trial indicated 65% of patients treated with icotrokinra achieved an Investigator's Global Assessment (IGA) score of 0 or 1 at 16 weeks, compared to 8% of the placebo group (P <.001). Psoriasis Area and Severity Index (PASI) 90 response rates were 50% for icotrokinra versus 4% for placebo (P <.001). By week 24, 74% reached an IGA score of 0 or 1, and 65% achieved PASI 90, with 46% achieving complete skin clearance (IGA 0) and 40% reaching PASI 100. Safety data revealed adverse events occurred in 49% of both the icotrokinra and placebo groups, with no new safety concerns.

Buoyed by these results and positive topline data from the ICONIC-ADVANCE 1 and 2 studies demonstrating superiority over deucravacitinib, Johnson and Johnson announced plans for the ICONIC-ASCEND trial on March 08, 2025. This upcoming study aims to be the first head-to-head trial comparing an oral therapy against an injectable biologic in moderate-to-severe psoriasis.

For more on the trial, potential of icotrokinra in plaque psoriasis, and what questions related to its use remain unanswered, check out our interview with Bissonnette from the conference floor.

Relevant disclosures for Bissonnette include Abbvie, Admiral, Alumis, Amgen, Bausch, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Incyte, GlaxoSmithKline, Janssen Pharmaceuticals, Leo Pharmaceuticals, Merck, Novartis, and others.

References:

1. Bissonnette R. Icotrokinra, a Targeted Oral Peptide That Selectively Blocks the Interleukin-23–Receptor, for the Treatment of Moderate-to-Severe Plaque Psoriasis. Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.

2. Johnson and Johnson. ICOTROKINRA results show potential to set a new standard of treatment in plaque psoriasis. JNJ.com. March 8, 2025. Accessed March 8, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-potential-to-set-a-new-standard-of-treatment-in-plaque-psoriasis.