Phase 3 Results From an Innovative Trial Design of Treating Plaque Psoriasis Involving Difficult-to-Treat, High-Impact Sites With Icotrokinra, a Targeted Oral Peptide That Selectively Inhibits the IL-23–Receptor

Melinda J. Gooderham¹, Edward Lain², Robert Bissonnette³, Yu-Huei Huang⁴, Charles Lynde⁵, Matthias Hoffmann⁶, Joseph F Merola⁷, Eingun J. Song⁸, Jessica H. Rubens⁹, Amy M. DeLozier⁹, Ming-Chun Hsu⁹ and Richard B. Warren¹⁰, ¹SKiN Centre for Dermatology, Queen's University, & Probity Medical Research, Peterborough, ON, ON, Canada, ²Austin Institute for Clinical Research, Sanova Dermatology, Austin, TX, USA, Austin, TX, ³Innovaderm Research, Montreal, QC, Canada, Montreal, QC, ⁴Chang Gung Memorial Hospital & Chang Gung University, Taoyuan City, Taiwan, Taoyuan City, Taiwan (Republic of China), ⁵University of Toronto, Lynde Institute for Dermatology & Lynderm Research Inc, Markham, ON, Canada, ON, Canada, ⁶Dermatology Practice Dr. M Hoffmann, Witten, Germany, Witten, Germany, ⁷Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ⁸Frontier Derm, Mill Creek, WA, USA, WA, ⁹Johnson & Johnson, Spring House, PA, USA, Spring House, PA, ¹⁰Dermatology Centre, Northern Care Alliance, NHS Foundation Trust & Division of Musculoskeletal and Dermatological Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom

Meeting: ACR Convergence 2025

Keywords: autoimmune diseases, immunology, Randomized Trial

Session Information

Date: Sunday, October 26, 2025

Title: (0554–0592) Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster I

Session Type: Poster Session A

Session Time: 10:30AM-12:30PM

Background/Purpose: Icotrokinra (ICO), a first-in-class, targeted oral peptide that binds and inhibits the interleukin (IL)-23R, was evaluated in ICONIC-TOTAL (NCT06095102).

Methods: This Phase 3 trial included plaque psoriasis (PsO) severity of body surface area (BSA) ≥1%/Investigator’s Global Assessment (IGA) ≥2 and employed a novel basket-like design to evaluate 3 cohorts of adults & adolescents (≥12 to < 18 years) with at least moderate, difficult-to-treat, high-impact skin sites: scalp (scalp-specific [ss]-IGA ≥3), genital (static Physician Global Assessment of Genitalia [sPGA-G] ≥3), and/or hand/foot (hf-PGA ≥3). Primary (IGA 0/1: clear [0]/almost clear [1] & ≥2-grade improvement) and key secondary (ss-IGA 0/1, sPGA-G 0/1, hf-PGA 0/1) endpoints were assessed at Week 16.

Results: 311 randomized patients (ICO=208/placebo=103) with scalp (n=252), genital (n=140), and/or hand/foot (n=71) PsO received once-daily ICO 200 mg or placebo through Week 16. ICO vs placebo met primary (IGA 0/1: 57% vs 6%; P < 0.001) and scalp and genital key secondary endpoints (ss-IGA 0/1: 66% vs 11%; sPGA-G 0/1: 77% vs 21%; both P < 0.001), and showed higher hf-PGA 0/1 (42% vs 26%; P=0.144). Patient-reported scalp and genital PsO improvements were statistically significantly superior to placebo. Proportions of ICO and placebo patients with ≥1 adverse event (AE) were 50% & 42% (the most commonly reported AE was nasopharyngitis) and GI AE were 7.2% & 7.8%, respectively.

Conclusion: ICO demonstrated significantly higher rates of overall skin, scalp, and genital PsO clearance vs placebo with a favorable safety profile. Basket-like trial designs can be used to efficiently study special skin sites in patients with PsO and other diseases.

Disclosures: M. Gooderham: AbbVie, 12,, 1, 6, Akros, 12,, 1, 6, Amgen, 12,, 1, 6, AnaptysBio, 12,, 1, 6, Apogee, 12,, 1, 6, Arcutis Biotherapeutics, 12,, 1, 6, Aristea, 12,, 1, 6, Aslan, 12,, 1, 6, Bausch Health, 12,, 1, 6, Boehringer-Ingelheim, 12,, 1, 6, Bristol-Myers Squibb(BMS), 12,, 1, 6, Celgene, 12,, 1, 6, Dermavant, 12,, 1, 6, Dermira, 12,, 1, 6, Eli Lilly, 12,, 1, 6, Galderma, 12,, 1, 6, GlaxoSmithKlein(GSK), 12,, 1, 6, Incyte, 12,, 1, 6, Inmagene, 12,, 1, 6, JAMP, 12,, 1, 6, Janssen, 12,, 1, 6, Kyowa Kirin, 12,, 1, 6, LEO Pharma, 12,, 1, 6, MedImmune, 12,, 1, 6, Meji, 12,, 1, 6, Merck, 12,, 1, 6, MoonLake Immunotherapeutics, 12,, 1, 6, Nimbus, 12,, 1, 6, Novartis, 12,, 1, 6, Pfizer, 12,, 1, 6, Regeneron, 12,, 1, 6, Roche, 12,, 1, 6, Sanofi Genzyme, 12,, 1, 6, Sun Pharma, 12,, 1, 6, Takeda, 12,, 1, 6, Tarsus Pharmaceuticals, 12,, 1, 6, UCB, 12,, 1, 6, Union Therapeutics, 12,, 1, 6, Ventyx Biosciences, 12,, 1, 6, Vyne Therapeutics, 12,, 1, 6; E. Lain: AbbVie, 12, Personal fees, Arcutis, 12, Personal fees, Bristol-Myers Squibb(BMS), 12, Personal fees, Dermavant, 12, Personal fees, Eli Lilly, 12, Personal fees, EPI Health, 12, Personal fees, Galderma, 12, Personal fees, Incyte, 12, Personal fees, Ortho Dermatologics, 12, Personal fees, Pfizer, 12, Personal fees; R. Bissonnette: AbbVie, 2, 5, Amgen, 2, 5, Apogee, 2, Arcutis, 2, 5, Asana, 2, Bellus, 5, BioMimetix, 5, Bluefin, 2, Boehringer-Ingelheim, 2, Boston Pharma, 2, Cara Therapeutics, 5, Clexio, 5, Dermavant, 2, 5, Eli Lilly, 2, Escient, 2, 5, Evidera, 2, Fresh Tracks, 5, Galderma, 2, GlaxoSmithKline, 2, Incyte, 2, 5, Innovaderm, 11, Janssen, 2, 5, LEO Pharma, 2, 5, Merck, 5, Novartis, 2, Opsidio, 5, Pfizer, 2, 5, RAPT Therapeutics, 2, Sanofi Genzyme, 2, Sanofi-Aventis, 2, Target RWE, 2, 5, Vyne Therapeutics, 5, Xencor, 5; Y. Huang: AbbVie, 1, 6, Celgene, 1, 6, Eli-Lilly, 12,, 6, Galderma, 12,, Janssen-Cilag Pharmaceutica, 12,, Novartis, 12,, 6, Pfizer, 1, 6; C. Lynde: AbbVie, 12,, 12, Personal Fees, Akros, 12,, Amgen, 12,, 12, Personal Fees, Aralez, 12, Personal Fees, Arcutis, 12,, Bausch Health, 12,, 12, Personal Fees, Bayer, 12,, 12, Personal Fees, Bioderma, 12,, 12, Personal Fees, BioJAMP, 12,, 12, Personal Fees, Boehringer-Ingelheim, 12,, 12, Personal Fees, Bristol-Myers Squibb(BMS), 12,, 12, Personal Fees, Celgene, 12,, 12, Personal Fees, Celltrion, 12,, 12, Personal Fees, CeraVe, 12,, 12, Personal Fees, Cipher, 12,, 12, Personal Fees, Concert, 12,, Dermavant, 12,, 12, Personal Fees, Devonian, 12,, Eli Lilly, 12,, 12, Personal Fees, Evelo, 12,, Fresnius Kabi, 12, Personal Fees, Galderma, 12,, 12, Personal Fees, GlaxoSmithKline, 12,, 12, Personal Fees, InCyte, 12,, 12, Personal Fees, Innovaderm, 12, Personal Fees, Intega Skin, 12,, 12, Personal Fees, Janssen, 12,, 12, Personal Fees, Kyowa Kirin, 12,, 12, Personal Fees, La Roche Posay, 12,, 12, Personal Fees, L’Oreal, 12,, 12, Personal Fees, LEO Pharma, 12,, 12, Personal Fees, Medexus, 12,, 12, Personal Fees, MedX, 12, Personal Fees, Merck, 12,, 12, Personal Fees, MoonLake, 12,, Naos, 12,, 12, Personal Fees, Nimbus, 12,, Novartis, 12,, 12, Personal Fees, P&G, 12,, 12, Personal Fees, PediaPharm, 12,, 12, Personal Fees, Pfizer, 12,, 12, Personal Fees, Regeneron, 12,, 12, Personal Fees, Roche, 12,, 12, Personal Fees, Sandoz, 12,, 12, Personal Fees, Sanofi Genzyme, 12,, 12, Personal Fees, Sentrex, 12,, 12, Personal Fees, Skinceuticals, 12, Personal Fees, Sun Pharma, 12,, 12, Personal Fees, Takeda, 12,, 12, Personal Fees, TEVA, 12,, 12, Personal Fees, Tribute, 12,, 12, Personal Fees, UCB, 12,, 12, Personal Fees, Valeant, 12,, 12, Personal Fees, Viatris, 12,, 12, Personal Fees, Volo Health, 12,, 12, Personal Fees; M. Hoffmann: AbbVie, 12,, 1, 2, 5, 6, Almirall, 12,, 1, 2, 5, 6, Biofrontera, 12,, 1, 2, 5, 6, Bristol-Myers Squibb(BMS), 12,, 1, 2, 5, 6, Dermapharm, 12,, 1, 2, 5, 6, Dermasence, 12,, 1, 2, 5, 6, Eli Lilly, 12,, 1, 2, 5, 6, Forward, 12,, 1, 2, 5, 6, Galderma, 12,, 1, 2, 5, 6, Incyte, 12,, 1, 2, 5, 6, Janssen, 12,, 1, 2, 5, 6, Kiniksa, 12,, 1, 2, 5, 6, LEO Pharma, 12,, 1, 2, 5, 6, L'Oréal, 12,, 1, 2, 5, 6, MSD, 12,, 1, 2, 5, 6, Nektar Therapeutics, 12,, 1, 2, 5, 6, Novartis, 12,, 1, 2, 5, 6, Pfizer, 12,, 1, 2, 5, 6, Pierre Fabre, 12,, 1, 2, 5, 6, Sanofi, 12,, 1, 2, 5, 6, Schering-Plough, 12,, 1, 2, 5, 6, Smerud Medical Research, 12,, 1, 2, 5, 6, Stallergenes Greer, 12,, 1, 2, 5, 6, UCB, 12,, 1, 2, 5, 6, Viatris, 12,, 1, 2, 5, 6; J. Merola: AbbVie, 2, Amgen, 2, 5, AstraZeneca, 2, 5, Biogen, 2, 5, Boehringer Ingelheim, 2, 5, Bristol Myers Squibb, 2, 5, Dermavant, 2, 5, Eli Lilly and Company, 2, 5, Incyte, 2, Janssen, 2, 5, LEO Pharma, 2, MoonLake Immunotherapeutics, 2, 5, Novartis, 2, Pfizer, 2, Sanofi-Regeneron, 2, 5, Sun Pharma, 5, UCB, 2, 5; E. Song: AbbVie, 12,, 2, 6, Alyphn, 12,, 2, 6, Amgen, 12,, 2, 6, Apogee, 12,, 2, 6, Arcutis, 12,, 2, 6, ASLAN, 12,, 2, 6, Boehringer-Ingelheim, 12,, 2, 6, Bristol-Myers Squibb(BMS), 12,, 2, 6, Dermavant, 12,, 2, 6, Eli Lilly, 12,, 2, 6, Janssen, 12,, 2, 6, LEO Pharma, 12,, 2, 6, Novartis, 12,, 2, 6, Ortho-dermatologics, 12,, 2, 6, Pfizer, 12,, 2, 6, Regeneron Pharmaceuticals, 12,, 2, 6, Sanofi, 12,, 2, 6, Sun Pharma, 12,, 2, 6, UCB, 12,, 2, 6; J. Rubens: Johnson & Johnson, 3, 11; A. DeLozier: Johnson & Johnson, 3, 11; M. Hsu: Johnson & Johnson, 3, 11; R. Warren: AbbVie, 2, 5, 6, Almirall, 2, 5, 6, Amgen, 2, 5, Arena, 2, Astellas, 2, Avillion, 2, Biogen, 2, Boehringer Ingelheim, 2, Bristol Myers Squibb, 2, 6, Celgene, 2, 5, DICE Therapeutics, 2, Eli Lilly and Company, 2, 5, 6, GSK, 2, Janssen, 2, 5, 6, LEO Pharma, 2, 5, Meiji Pharma, 2, Novartis, 2, 5, 6, Pfizer, 2, 5, RAPT Therapeutics, 2, Sanofi, 2, Sun Pharma, 2, UCB, 2, 5, Union, 2.

To cite this abstract in AMA style:

Gooderham M, Lain E, Bissonnette R, Huang Y, Lynde C, Hoffmann M, Merola J, Song E, Rubens J, DeLozier A, Hsu M, Warren R. Phase 3 Results From an Innovative Trial Design of Treating Plaque Psoriasis Involving Difficult-to-Treat, High-Impact Sites With Icotrokinra, a Targeted Oral Peptide That Selectively Inhibits the IL-23–Receptor [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/phase-3-results-from-an-innovative-trial-design-of-treating-plaque-psoriasis-involving-difficult-to-treat-high-impact-sites-with-icotrokinra-a-targeted-oral-peptide-that-selectively-inhibits-the-il/. Accessed .

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