POS1071 Treatment of Plaque Psoriasis Involving High-Impact Areas with Icotrokinra, a Targeted Oral Peptide That Selectively Binds the Interleukin-23–Receptor: Results Through Week 16 of the Phase 3, Randomized, Double-blind, Placebo-Controlled ICONIC-TOTAL Trial

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Background: Icotrokinra (ICO), a first-in-class, targeted oral peptide that selectively binds to the interleukin-23 receptor and inhibits signaling, demonstrated significant, durable skin clearance and a safety profile similar to placebo in Phase 2 plaque psoriasis studies. Objectives: To report findings from the first Phase 3 study (ICONIC-TOTAL) in high-impact area psoriasis. Methods: ICONIC-TOTAL (NCT06095102) randomized adults and adolescents (≥12 years to <18 years) with plaque psoriasis (body surface area [BSA] ≥1%; Investigator's Global Assessment [IGA] ≥2) and at least moderate scalp (scalp-specific IGA [ss-IGA] ≥3), genital (static Physician's Global Assessment of Genitalia [sPGA-G] ≥3), and/or hand/foot PGA (hf-PGA ≥3) psoriasis to once daily ICO 200 mg or placebo (2:1) through Week 16. The primary endpoint was IGA 0/1 response (clear [0] or almost-clear [1] skin and ≥2-grade improvement) at Week 16. Key secondary endpoints included achievement of ss-IGA 0/1, sPGA-G 0/1, and/or hf-PGA 0/1 within applicable participant cohorts, with additional clinician-reported or patient-reported outcomes at Week 16. Results: ICONIC-TOTAL randomized 311 participants (ICO=208; placebo=103) with at least moderate scalp (n=252), genital (n=140), and/or hand/foot (n=71) psoriasis. The primary endpoint was met: 57% of ICO-treated vs 6% of placebo-treated participants achieved IGA 0/1 at Week 16 (P<0.001). ICO demonstrated higher response rates vs placebo for ss-IGA 0/1 (66% vs 11%; P<0.001), sPGA-G 0/1 (77% vs 21%; P<0.001), and hf-PGA 0/1 (42% vs 26%; P=0.144). Patient-reported and clinician-reported improvements in scalp and genital psoriasis were also statistically significant within multiplicity-adjusted analyses. Similar proportions of ICO-treated and placebo-treated participants had ≥1 adverse events (50% and 42%, respectively; most commonly nasopharyngitis) and gastrointestinal-related events (7.2% and 7.8%, respectively) through Week 16. Conclusion: ICO demonstrated significantly higher rates of overall skin, scalp, and genital psoriasis clearance, and a favorable safety profile, in adults and adolescents with BSA ≥1% and at least moderate psoriasis affecting high-impact areas. REFERENCES: NIL . Acknowledgements: NIL . Disclosure of Interests: Melinda Gooderham Speaker, investigator, or advisory board member for AbbVie, Acelyrin, Akros, Alumis, Amgen, AnaptysBio, Apogee, Arcutis, Arena, Aslan, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Coherus, Dermavant, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, InMagene, JAMP Pharma, Janssen, Kyowa Kirin, LEO, Medimmune, Merck, Moonlake, Nimbus, Novartis, Pfizer, Regeneron, Reistone, Sanofi Genzyme, Sun, Takeda, Tarsus, UCB, Union, and Vyne, Edward (Ted) Lain Speaker, consultant, advisory board member, or principal investigator for AbbVie, Aslan Pharmaceuticals, Biofrontera, Caliway, Cassiopea, Castle Biosciences, Concert Pharmaceuticals, Celldex Therapeutics, Eli Lilly, Evoimmune, Galderma, Incyte, Janssen, L'Oreal, Nielsen BioSciences, Peregrine Ophtalmic, Pfizer, Regeneron, RegenX Science, Sanofi, Symatese, Takeda, Teoxane, UCB, Veradermics, and Vyne, Robert Bissonnette Shareholder of Innovaderm Research, Employee of Innovaderm Research, Advisory board member, consultant, speaker, and/or investigator for and received honoraria and/or grants from AbbVie, Alumis, Amgen, Arcutis, Bausch Health, BMS/Celgene, Boston, Dermavant, Eli Lilly, Janssen, LEO Pharma, Nimbus, Novartis, Pfizer, Regeneron, UCB, VentyxBio, and Xencor, Yu-Huei Huang Conducted clinical trials for or received honoraria as a consultant for AbbVie, Bristol Myers Squibb, Celgene, Janssen-Cilag Pharmaceuticals, Novartis, and Pfizer Pharmaceuticals, Charles Lynde Speaker and/or consultant for AbbVie, Amgen, Aralez, Arcutis, Bausch Health, Bayer, Bioderma, BioJAMP, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, CeraVe, Cipher, Dermavant, Eli Lilly, Fresnius Kabi, Galderma, GSK, InCyte, Innovaderm, Intega Skin, Janssen, Kyowa Kirin, La Roche Posay, LEO Pharma, L'Oreal, Medexus, MedX, Merck, Naos, Novartis, P&G, Pediapharm, Pfizer, Regeneron, Roche, Sandoz, Sanofi Genzyme, Sentrex, SkinCeuticals, SunPharma, Takeda, TEVA, Tribute, UCB, Valeant, Viatris, and Volo Health, Principal investigator for AbbVie, Acelyrin, Akros, Altius, Amgen, Aralez, Arcutis, Avillion, Bausch Health, Bioderma, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Cipher, Concert, Dermavant, Devonian, Eli Lilly, Evelo, Galderma, GSK, InCyte, Innovaderm, Intega Skin, Janssen, Kyowa Kirin, La Roche Posay, LEO Pharma, L'Oreal, Medexus, MedX, Merck, MoonLake, Naos, Nimbus, Novartis, P&G, Pediapharm, Pfizer, Regeneron, Roche, Sandoz, Sanofi Genzyme, Sentrex, SunPharma, Takeda, TEVA, Tribute, UCB, Valeant, Viatris, and Volo Health, Matthias Hoffmann Advisory board member, consultant, speaker and/or investigator for and/or received honoraria and/or grants from AbbVie, Almirall, Biofrontera, Bristol Myers Squibb, Dermapharm, Dermasence, Forward, Galderma, Incyte, Janssen, Kiniksa, Leo Pharma, Lilly, L'Oréal, MSD, Nektar Therapeutics, Novartis, Pierre Fabre, Pfizer, Sanofi, Schering-Plough, Smerud Medical Research, Stallergenes Greer, Viatris, and UCB, Joseph F. Merola Consultant for AbbVie, Amgen, Astra-Zeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Incyte, Janssen, Leo, Novartis, Pfizer, Sanofi-Regeneron, Sun, and UCB, Grant/research support from AbbVie, Amgen, Astra-Zeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Incyte, Janssen, Leo, Novartis, Pfizer, Sanofi-Regeneron, Sun, and UCB, Eingun James Song Investigator, consultant, and/or speaker for AbbVie, Acelyrin, Alphyn, Alumis, Amgen, Apogee, Arcutis, ASLAN, Boehringer Ingelheim, Bristol Myers Squibb, CorEvitas, Dermavant, DermBiont, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, MoonLake, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, TARGET PharmaSolutions, TIMBER, and UCB, Jessica H. Rubens May own stock/stock options in Johnson & Johnson, Employee of Janssen Research and Development, LLC, a Johnson & Johnson company, Amy M. DeLozier May own stock/stock options in Johnson & Johnson, Employees of Janssen Research and Development, LLC, a Johnson & Johnson company, Ming-Chun Hsu May own stock/stock options in Johnson & Johnson, Employees of Janssen Research and Development, LLC, a Johnson & Johnson company, Richard B. Warren Consultant and/or speaker for AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, DiCE, Galderma, GSK, Janssen, Lilly, Leo, Meiji Pharma, Novartis, Pfizer, RAPT Pharmaceuticals, Sanofi, Sun Pharma, UCB, and UNION, Research grants from AbbVie, Almirall, Amgen, Celgene, Janssen, Lilly, Leo, Novartis, Pfizer, and UCB. © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.

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