Efficacy and Safety of Icotrokinra, a Novel Targeted Oral Peptide (IL-23R-Inhibitor), in Adolescents With Moderate-to-Severe Plaque Psoriasis: Subgroup Analyses From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ICONIC-LEAD)

Lawrence Eichenfield¹, Ricardo Galimberti², Adelaide Hebert³, Wen-Hui Wang⁴, Jennifer Soung⁵, Nina Magnolo⁶, John Browning⁷, Angela Moore⁸, Mark Lebwohl⁹, Dagmar Wilsmann-Theis¹⁰, Joseph F Merola¹¹, Georgios Kokolakis¹², Dariusch Mortazawi¹³, Parbeer Grewal¹⁴, Megan Miller¹⁵, Joseph Cafone¹⁶, Shu Li¹⁷, Gigi Jiang¹⁷, Fabio Nunes¹⁷, Cynthia DeKlotz¹⁸ and Amy Paller¹⁹, ¹University of California, San Diego School of Medicine, La Jolla, CA, USA, La Jolla, CA, ²Hosp Italiano de Buenos Aires, Buenos Aires, Argentina, Buenos Aires, Argentina, ³University of Texas Medical School-Houston, Bellaire, TX, USA, Bellaire, TX, ⁴Peking University Third Hospital, Haidian District, Beijing, China, Beijing, China (People's Republic), ⁵Southern California Dermatology, Inc, Santa Ana, CA, USA, Santa Ana, ⁶University Hospital Muenster, Muenster, Germany, Muenster, Germany, ⁷Methodist Children's Hospital, San Antonio, TX, USA, San Antonio, TX, ⁸Baylor University Medical Center, Dallas, TX, USA, Dallas, TX, ⁹Icahn School of Medicine at Mount Sinai, New York, NY, ¹⁰University Hospital Bonn, Center for Skin Diseases, Bonn, Germany, Bonn, Germany, ¹¹Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ¹²Charité-Universitätsmedizin Berlin, Berlin, Germany, Berlin, Germany, ¹³Clinical Research Center, Remscheid, Germany, Remscheid, Germany, ¹⁴University of Alberta, Edmonton, Alberta, Canada, Edmonton, AB, Canada, ¹⁵Johnson & Johnson, San Diego, CA, USA, San Diego, CA,, CA, ¹⁶Johnson & Johnson, San Diego, CA, USA, San Diego, CA, CA, ¹⁷Johnson & Johnson, Spring House, PA, USA, Spring House, PA, ¹⁸Johnson & Johnson, San Diego, CA, USA, San Diego, CA, ¹⁹Northwestern University Feinberg School of Medicine, Chicago, IL, USA, Chicago, IL

Meeting: ACR Convergence 2025

Keywords: Biologicals, clinical trial, Dermatology, immunology, Pediatric rheumatology

Session Information

Date: Monday, October 27, 2025

Title: Abstracts: Spondyloarthritis Including Psoriatic Arthritis – Treatment I: Therapies (0873–0878)

Session Type: Abstract Session

Session Time: 10:30AM-10:45AM

Background/Purpose: Icotrokinra (ICO), a novel targeted oral peptide, binds the interleukin (IL)-23 receptor to inhibit IL-23 signaling. ICONIC-LEAD (NCT06095115) is the first Phase 3 study in moderate-to-severe psoriasis to assess the efficacy and safety of a systemic therapy simultaneously in adolescents and adults.

Methods: In ICONIC-LEAD, adolescents (12 to < 18 years) with moderate-to-severe psoriasis (body surface area [BSA] ≥10%, Psoriasis Area and Severity Index [PASI] ≥12, Investigator’s Global Assessment [IGA] ≥3) and body weight ≥40 kg were randomized 2:1 to once-daily ICO 200 mg or placebo through Week 16. Placebo patients transitioned to ICO after Week 16. Overall ICONIC-LEAD co-primary endpoints, IGA 0/1 response (IGA score=cleared [0] or minimal [1] and ≥2-grade improvement) and PASI 90 response at Week 16, were assessed in adolescents, as were the efficacy and safety through Week 24.

Results: Adolescents comprised 9.6% (66/684) of the ICONIC-LEAD population. The mean age was 15 years and the mean psoriasis disease duration was 5.2 years (Table). Higher proportions of adolescents receiving ICO vs placebo achieved clear/almost clear skin at Week 16 (IGA 0/1: 84.1% vs 27.3%; PASI 90: 70.5% vs 13.6%; nominal p< 0.001). At Week 24, rates of clear/almost clear skin with ICO were 86.4% (IGA 0/1) and 88.6% (PASI 90; Figure). Response patterns were consistent for IGA 0 and PASI 100. At Week 16, 50% of ICO and 73% of placebo adolescents had ≥1 adverse event; no safety signals emerged through Week 24.

Conclusion: In adolescents with moderate-to-severe psoriasis, higher proportions of ICO vs placebo participants achieved clear/almost clear skin at Week 16, with unprecedented response rates at Week 24 and a favorable adverse event profile.

Table. Baseline Demographics, Disease Characteristics, and Previous Treatment Among Adolescents With Moderate-to-Severe Psoriasis

Figure. IGA 0/1 and PASI 90 Response at W16 and W24

Disclosures: L. Eichenfield: AbbVie, 2, 12, Investigator, Almirall, 2, Amgen, 2, 12, Investigator, Apogee, 2, Arcutis, 2, 12, Investigator, Attovia, 2, Bausch, 12, Investigator, Bristol Myers Squibb, 2, Castle Biosciences, 12, Investigator, Dermavant, 2, 12, Investigator, Eli Lilly, 12, Investigator, Forte, 2, Galderma, 2, 12, Investigator, Incyte, 2, 12, Investigator, Janssen, 2, LEO Pharma, 2, Novartis, 2, Pfizer, 2, 12, Investigator, Regeneron, 2, 12, Investigator, Sanofi, 2, Sanofi-Genzyme, 12, Investigator, Seanergy, 2, UCB, 2, Verrica, 2; R. Galimberti: Amgen, 12, Investigator, Biogen, 12, Investigator, Bristol Myers Squibb, 12, Investigator, Eli Lilly, 12, Investigator, GlaxoSmithKline, 12, Investigator, Janssen, 12, Investigator, Merck Sharp & Dohme, 12, Investigator, Novartis, 12, Investigator, Pfizer, 12, Investigator, Sanofi, 12, Investigator; A. Hebert: AbbVie, 5, Almirall, 6, Apogee, 6, Arcutis, 5, 6, Castle Biosciences, 6, Dermavant, 5, 6, Eli Lilly, 5, GlaxoSmithKline, 12, DSMB, Incyte, 6, Janssen, 5, 6, OrthoDermatologics, 12, DSMB, Pfizer, 5, 6, Sanofi-Regeneron, 12, DSMB, Takeda, 5, UTHealth McGovern Medical School-Houston, 3, Verrica, 6; W. Wang: AbbVie, 2, 6, 12, Investigator, Amgen, 2, 6, 12, Investigator, Arcutis, 2, 6, 12, Investigator, Eli Lilly, 2, 6, 12, Investigator, Janssen, 2, 6, 12, Investigator, LEO Pharma, 2, 6, 12, Investigator, National Psoriasis Foundation, 2, 6, 12, Investigator, Novartis, 2, 6, 12, Investigator, Pfizer, 2, 6, 12, Investigator, Regeneron, 2, 6, 12, Investigator, Sanofi, 2, 6, 12, Investigator, UCB, 2, 6, 12, Investigator; J. Soung: AbbVie, 5, 12, Personal fees, Dermavant, 5, Eli Lilly, 12, Non-financial support (manuscript preparation during the conduct of the study), Kyowa Kirin, 5, LEO Pharma, 5, 12, Personal fees, Pfizer, 5, 12, Personal fees, Regeneron, 5, Sanofi, 5, 12, Personal fees; N. Magnolo: AbbVie, 1, 2, 6, Almirall, 1, 2, 6, Boehringer Ingelheim, 1, 2, 6, Bristol Myers Squibb, 1, 2, 6, Dr. Wolff, 1, 2, 6, Eli Lilly, 1, 2, 6, Janssen, 1, 2, 6, La Roche-Posay, 1, 2, 6, LEO Pharma, 1, 2, 6, Novartis, 1, 2, 6, Pfizer, 1, 2, 6, Sanofi, 1, 2, 6, UCB, 1, 2, 6; J. Browning: AbbVie, 12, Investigator, Amgen, 12, Investigator, Arcutis, 12, Investigator, Dermata, 12, Investigator, Dermavant, 2, 12, Investigator, Eli Lilly, 12, Investigator, Galderma, 6, Incyte, 12, Investigator, Janssen, 12, Investigator, Krystal, 6, Pfizer, 6, 12, Investigator, Quoin, 12, Investigator, Regeneron, 6, 12, Investigator, Sanofi, 6, 12, Investigator, Takeda, 12, Investigator, UCB, 12, Investigator, Verrica, 6; A. Moore: AbbVie, 5, 6, Acelyrin, 5, 6, Arcutis, 5, 6, Bristol Myers Squibb, 5, 6, Dermavant, 5, 6, Eli Lilly, 5, 6, Galderma, 5, 6, Incyte, 5, 6, Janssen, 5, 6, Novartis, 5, 6, Pfizer, 5, 6, Sanofi, 5, 6, Takeda, 5, 6, UCB, 5, 6; M. Lebwohl: AbbVie, 5, Almirall, 2, AltruBio Inc, 2, Apogee Therapeutics, 2, Arcutis Biotherapeutics, 2, 5, AstraZeneca, 2, Atomwise, 2, Avotres, 2, 5, Boehringer Ingelheim, 2, 5, Bristol Myers Squibb, 2, Cara Therapeutics, 5, Castle Biosciences, 2, Celltrion Biosciences, 2, Clexio Biosciences, 5, CorEvitas, 2, Dermavant, 2, 5, Dermsquared, 2, Eli Lilly, 5, Evommune, Inc, 2, Facilitation of International Dermatology Education, 2, Forte Biosciences, 12, Facilitation of International Dermatology Education, Galderma, 12, Facilitation of International Dermatology Education, Genentech, 12, Facilitation of International Dermatology Education, Incyte, 5, 12, Facilitation of International Dermatology Education, Inozyme, 5, Janssen, 5, LEO Pharma, 12, Facilitation of International Dermatology Education, Meiji Seika Pharma, 12, Facilitation of International Dermatology Education, Mindera, 12, Facilitation of International Dermatology Education, Mirium Pharmaceuticals, 2, Mount Sinai, 3, Pfizer, 5, 12, Facilitation of International Dermatology Education, Sanofi-Regeneron, 5, 12, Facilitation of International Dermatology Education, Seanergy, 12, Facilitation of International Dermatology Education, Strata, 12, Facilitation of International Dermatology Education, Takeda, 12, Facilitation of International Dermatology Education, Trevi Therapeutics, 12, Facilitation of International Dermatology Education, UCB, 5, Verrica Pharmaceuticals, 2; D. Wilsmann-Theis: AbbVie, 1, 6, 12, Investigator, Almirall, 1, 6, 12, Investigator, Amgen, 1, 6, 12, Investigator, Biogen, 1, 6, 12, Investigator, Boehringer Ingelheim, 1, 6, 12, Investigator, Bristol Myers Squibb, 1, 6, 12, Investigator, Celgene, 1, 6, 12, Investigator, Eli Lilly, 1, 6, 12, Investigator, GlaxoSmithKline, 1, 6, 12, Investigator, Hexal, 1, 6, 12, Investigator, Incyte, 1, 6, 12, Investigator, Janssen-Cilag, 1, 6, 12, Investigator, LEO Pharma, 1, 6, 12, Investigator, Medac, 1, 6, 12, Investigator, Merck Sharp & Dohme, 1, 6, 12, Investigator, MoonLake Immunotherapeutics, 1, 6, 12, Investigator, Novartis, 1, 6, 12, Investigator, Pfizer, 1, 6, 12, Investigator, UCB, 1, 6, 12, Investigator; 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; G. Kokolakis: Abbott, 1, 6, AbbVie, 1, 6, Actelion Pharmaceuticals, 1, 6, Amgen, 1, 6, Basilea Pharmaceutica, 1, 6, Bayer, 1, 6, Biogen IDEC, 1, 6, Boehringer Ingelheim, 1, 6, Bristol Myers Squibb, 1, 6, Celgene, 1, 6, Eli Lilly, 1, 6, Hexal, 1, 6, Janssen Cilag, 1, 6, LEO Pharma, 1, 6, Merck Sharp & Dohme, 1, 6, Mylan, 1, 6, Novartis, 1, 6, Parexel, 1, 6, Pfizer, 1, 6, Sanofi-Aventis, 1, 6, Takeda, 1, 6, UCB, 1, 6; D. Mortazawi: AbbVie, 1, 2, 6, 12, Investigator, Almirall, 1, 2, 6, 12, Investigator, Alumis, 1, 2, 6, 12, Investigator, Amgen, 1, 2, 6, 12, Investigator, Bristol Myers Squibb, 1, 2, 6, 12, Investigator, CVderm UKE, 1, 2, 6, 12, Investigator, Eli Lilly, 1, 2, 6, 12, Investigator, Forschungsdock CRO GmbH, 1, 2, 6, 12, Investigator, Johnson & Johnson, 1, 2, 6, 12, Investigator, LEO Pharma, 1, 2, 6, 12, Investigator, Moberg Pharma, 1, 2, 6, 12, Investigator, Novartis, 1, 2, 6, 12, Investigator, Pfizer, 1, 2, 6, 12, Investigator, Sanofi-Aventis, 1, 2, 6, 12, Investigator, UCB, 1, 2, 6, 12, Investigator, Viatris, 1, 2, 6, 12, Investigator; P. Grewal: AbbVie, 1, 2, 6, 12, Investigator, Amgen, 1, 2, 6, 12, Investigator, Anacor, 1, 2, 6, 12, Investigator, Apogee Therapeutics, 1, 2, 6, 12, Investigator, Arcutis, 1, 2, 6, Arena Pharmaceuticals, 12, Investigator, Aspen Pharmaceuticals, 1, 2, 6, Avillion, 12, Investigator, Bausch Health, 1, 2, 6, 12, Investigator, Biogen, 12, Investigator, Boehringer Ingelheim, 1, 2, 6, 12, Investigator, Bristol Myers Squibb, 1, 2, 6, 12, Investigator, Celgene, 1, 2, 6, 12, Investigator, Celltrion, 1, 2, 6, Cipher, 1, 2, 6, CorEvitas, 12, Investigator, Dermavant, 12, Investigator, Eli Lilly, 1, 2, 6, 12, Investigator, Galderma, 1, 2, 6, 12, Investigator, GlaxoSmithKline, 1, 2, 6, Incyte, 1, 2, 6, Innovaderm, 1, 2, 6, 12, Investigator, JAMP Pharma, 1, 2, 6, Johnson & Johnson/Janssen, 1, 2, 6, 12, Investigator, LEO Pharma, 1, 2, 6, 12, Investigator, Med Plan, 1, 2, 6, Meiji Seika Pharma, 12, Investigator, MoonLake Immunotherapeutics, 12, Investigator, Novartis, 1, 2, 6, 12, Investigator, Pfizer, 1, 2, 6, 12, Investigator, Regeneron, 1, 2, 6, 12, Investigator, Sandoz, 1, 2, 6, 12, Investigator, Sanofi-Aventis/Genzyme, 1, 2, 6, 12, Investigator, Sun Pharmaceuticals, 1, 2, 6, Takeda, 1, 2, 6, 12, Investigator, UCB, 1, 2, 6, 12, Investigator, Vitae, 12, Investigator; M. Miller: Johnson & Johnson, 3, 11; J. Cafone: Johnson & Johnson, 3, 11; S. Li: Johnson & Johnson, 3, 11; G. Jiang: Johnson & Johnson, 3, 11; F. Nunes: Johnson & Johnson, 3, 11; C. DeKlotz: Johnson & Johnson, 3, 11; A. Paller: AbbVie, 2, 12, Investigator and DSMB, Abeona, 2, 12, DSMB, Apogee, 2, Applied Pharma Research, 12, Investigator, Arcutis, 2, Aslan, 2, BioCryst, 2, Biomendics, 12, Investigator, Boehringer Ingelheim, 2, Bristol Myers Squibb, 2, Dermavant, 2, 12, Investigator, Eli Lilly, 12, Investigator, Galderma, 12, DSMB, Incyte, 2, 12, Investigator, Janssen, 12, Investigator, Johnson & Johnson, 2, Krystal, 2, 12, Investigator, LEO Pharma, 2, Mitsubishi Tanabe, 2, Nektar, 2, Primus, 2, Procter and Gamble, 2, Regeneron, 2, 12, Investigator, Sanofi, 2, Seanergy, 2, Timber, 12, Investigator, TWI Biotech, 2, UCB, 2, 12, Investigator.

To cite this abstract in AMA style:

Eichenfield L, Galimberti R, Hebert A, Wang W, Soung J, Magnolo N, Browning J, Moore A, Lebwohl M, Wilsmann-Theis D, Merola J, Kokolakis G, Mortazawi D, Grewal P, Miller M, Cafone J, Li S, Jiang G, Nunes F, DeKlotz C, Paller A. Efficacy and Safety of Icotrokinra, a Novel Targeted Oral Peptide (IL-23R-Inhibitor), in Adolescents With Moderate-to-Severe Plaque Psoriasis: Subgroup Analyses From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ICONIC-LEAD) [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/efficacy-and-safety-of-icotrokinra-a-novel-targeted-oral-peptide-il-23r-inhibitor-in-adolescents-with-moderate-to-severe-plaque-psoriasis-subgroup-analyses-from-a-phase-3-randomized-double-blin/. Accessed .

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