Safety of Icotrokinra Through 1 Year for the Treatment of Moderate-to-Severe Plaque Psoriasis and Psoriasis Affecting High-Impact Sites: Pooled Results Across the ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and 2 Phase 3 Trials.

Authors

Mark G Lebwohl, Melinda Gooderham, Richard B Warren, Lawrence F Eichenfield, Jessica H Rubens, Tracy Cardillo, Christopher Russo, Cynthia M C DeKlotz, Megan Miller-Kassamali, Luis Anaya Velarde, Ming-Chun Hsu, Shu Li, Ya-Wen Yang, Sarah Ofori, Robert Bissonnette, Jennifer Soung, Adelaide A Hebert, Linda Stein Gold

Published in

Dermatology and therapy. Aug 28, 2026. Epub Aug 28, 2026.

Abstract

Icotrokinra, a first-in-class targeted oral peptide, precisely blocks the interleukin (IL)-23 receptor and inhibits IL-23 pathway signaling. In phase 3 studies (ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1 and 2), icotrokinra provided superior skin clearance versus placebo and deucravacitinib in adults and adolescents with moderate-to-severe psoriasis and psoriasis affecting high-impact sites. This analysis evaluates icotrokinra safety through 1 year using pooled data from these four studies.
Icotrokinra-randomized participants received 200-mg pills once daily, and placebo-randomized participants crossed over to icotrokinra at week 16; participants randomized to deucravacitinib 6 mg (ICONIC-ADVANCE 1 and 2 only) switched to icotrokinra at week 24. Pooled safety data are summarized for the placebo-controlled period (week 0-16, all studies), active-controlled period (week 0-24, ICONIC-ADVANCE 1 and 2), and through week 52 (all studies).
During the placebo-controlled period across all studies, 568 participants received placebo and 1296 received icotrokinra. From week 0 to 24 in the ICONIC-ADVANCE studies, 632 participants received icotrokinra and 634 received deucravacitinib. Through week 52, 2400 icotrokinra-treated participants contributed 1840 participant-years [PY] of follow-up. Through week 16, in the icotrokinra and placebo groups, respectively, exposure-adjusted incidence rates/100 PY of adverse events (AEs; 232 and 269), serious AEs (5.2 and 6.6), infections (91 and 104), and AEs leading to discontinuation (6.6 and 10.0) were comparable between groups. Through week 24, in the ICONIC-ADVANCE studies, rates/100 PY with icotrokinra versus deucravacitinib were as follows: AEs, 204 vs 265; serious AEs, 6.4 vs 7.2; infections, 81 vs 119; AEs leading to discontinuation, 5.7 vs 6.8. Through week 52, event rates/100 PY in icotrokinra-treated participants were as follows: AEs, 167; serious AEs, 4.6; infections, 76; AEs leading to discontinuation, 3.0.
In this analysis of 2400 icotrokinra-treated participants with psoriasis followed through 1 year, icotrokinra demonstrated favorable safety; event rates through week 16 were similar to placebo and remained consistent through week 52.
GOV: NCT06095115, NCT06095102, NCT06143878, NCT06220604. Infographic available for this article. INFOGRAPHIC.

PMID:
42663861
Bibliographic data and abstract were imported from PubMed on 29 Aug 2026.

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