Durability of Response to Icotrokinra in Adults With Moderate-to-Severe Plaque Psoriasis: One-Year Results From the Phase 3, Placebo- and Active Comparator-Controlled ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 Trials
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ID: 319564
2026
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Abstract
BACKGROUND: Icotrokinra, a targeted oral peptide, precisely blocks the interleukin-23 receptor. In two phase 3 moderate-to-severe plaque psoriasis trials, ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604), icotrokinra provided significantly higher skin clearance rates versus placebo at Week 16 and deucravacitinib at Week 16 and 24. OBJECTIVES: Report findings through Week 52 of ICONIC-ADVANCE 1&2. METHODS: ICONIC-ADVANCE 1&2 randomised (2:1:2/4:1:4) adults with moderate-to-severe plaque psoriasis (body surface area ≥10%, Psoriasis Area and Severity Index [PASI] ≥12, Investigator's Global Assessment [IGA] ≥3) to icotrokinra 200 mg, placebo (transition to icotrokinra at Week 16), or deucravacitinib 6 mg once daily (transition to icotrokinra at Week 24). Outcomes assessed through Week 52 included proportions of participants achieving IGA 0/1 (with ≥2-grade improvement from baseline), PASI 90, IGA 0, PASI 100, scalp-specific IGA (ss-IGA) 0/1, patient-reported outcomes (clinically meaningful improvement [CMI; ≥4-point reduction] in Psoriasis Symptoms and Signs Diary [PSSD] itch, PSSD symptom score 0, Dermatology Life Quality Index [DLQI] 0/1), and adverse events (AEs). RESULTS: ICONIC-ADVANCE 1&2 randomised 1505 participants (774/731). Across the studies, skin clearance rates among icotrokinra-randomised participants increased through Week 24 and were durable through Week 52, with ∼70%-75% exhibiting clear/almost clear skin (IGA 0/1, PASI 90) and ∼50% demonstrating completely clear skin (IGA 0, PASI 100) during Weeks 24-52. Among participants achieving clear/almost clear skin at Week 16, ∼85%-90% maintained response at Week 52. Response rates for ss-IGA 0/1 and patient-reported outcomes were also durable through Week 52. Participants who transitioned from placebo or deucravacitinib to icotrokinra exhibited increasing response rates that were comparable to icotrokinra-randomised participants through Week 52. The AE profile of icotrokinra was similar to placebo through Week 16 and showed lower AE rates than deucravacitinib through Week 24; no safety signals were observed through Week 52. CONCLUSIONS: Once-daily icotrokinra provided robust, durable skin clearance and symptom improvement, with no safety signals, through Week 52 in adults with moderate-to-severe plaque psoriasis. Participants transitioning from placebo or deucravacitinib to icotrokinra achieved similar increased response rates to icotrokinra-randomised participants through Week 52. Findings support icotrokinra as a systemic therapy with long-term robust disease control and a favourable safety profile.
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| Authors | Linda Stein Gold, April W Armstrong, Jennifer Soung, Ronald Vender, Álvaro González Cantero, Matthias Hoffmann, Scott Guenthner, H Chih-Ho Hong, Dédée F. Murrell, Eingun James Song, Leon Kircik, Matthias Augustin, Maxwell Sauder, Sascha Gerdes, Ofelia Reyes-Servin, Bassey Edem, Jennifer Campbell, Kellen Cresswell, Lea Kephart, Shu Li, Ya-Wen Yang, Robert Bissonnette |
| Journal | the british journal of dermatology |
| Year | 2026 |
| DOI |
10.1093/bjd/ljag264
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| URL | |
| Keywords | Keywords not found |
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