ICONIC-LEAD: 1 Year Icotrokinra Data Confirm Durable Psoriasis Clearance, PRO Improvements in Adults, Adolescents, With Jennifer Soung, MD

One-year data from the phase 3 ICONIC-LEAD trial confirm that icotrokinra (ICOTYDE) delivers durable skin clearance and meaningful patient-reported improvements across adults and adolescents with moderate-to-severe plaque psoriasis with no new safety signals through week 52.^1,2

Icotrokinra is the first and only targeted oral peptide blocking the IL-23 receptor after being approved by the United States Food and Drug Administration (FDA) on March 18, 2026 for moderate-to-severe plaque PsO in adults and adolescents 12 and older.³

To discuss the findings presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting held in Denver, Colorado, from March 27-31, HCPLive spoke with Jennifer Soung, MD, Founder and Director of Clinical Research at Southern California Dermatology in Santa Ana, California, and ICONIC-LEAD investigator. ICONIC-LEAD enrolled 684 patients ≥12 years (adults, n = 618; adolescents, n = 66) with moderate-to-severe plaque PsO (BSA ≥10%, PASI ≥12, IGA ≥3). In the adult randomized-withdrawal analysis, of 341 week-24 responders re-randomized 1:1 to continue icotrokinra or withdraw to placebo, continuous icotrokinra produced superior maintenance of PASI 75 (89% vs. 30%; P <.001) and PASI 90 (84% vs. 21%; P <.001) at week 52, with median time to loss of response not reached in those continuing therapy versus 16.9 and 10.1 weeks for PASI 75 and PASI 90, respectively, among those re-randomized to placebo.

The adolescent data, presented across 2 companion posters at AAD, were particularly notable given the absence of approved advanced oral options for this population. Among adolescents randomized to icotrokinra (n = 44; mean age 15.0 years, mean PASI 19.8, 70% moderate/30% severe), 91% achieved IGA 0/1 and 86% achieved PASI 90 by week 52, with 89% of week-24 IGA 0/1 responders and 92% of week-24 PASI 90 responders maintaining those responses at week 52. Complete skin clearance rates were also substantial, with 64% achieving IGA 0 and 57% achieving PASI 100 during weeks 24–52. On patient-reported outcomes, more than 80% of icotrokinra-randomized adolescents reported clinically meaningful itch improvement (≥4-point PSSD improvement) through weeks 24–52, more than 50% reported complete symptom resolution (PSSD symptom score 0), approximately 40% reported complete sign resolution (PSSD sign score 0), and more than 80% reported psoriasis no longer impacted their health-related quality of life (CDLQI 0/1) — with improvements observed as early as week 2. Through week 52, no adolescent discontinued due to an adverse event, no serious infections occurred, and no malignancies were reported, with the overall safety profile consistent with the placebo-controlled period.

“This is the first time an advanced systemic has concurrently received approval for adults and adolescents at the same time, and that's a game changer, because our adolescent patients don’t really want an injection,” Soung said. “We also saw such amazing skin clearance rates in our adolescent patients. So I think that, again, making PsO treatment more accessible and easier for our patients means more of our patients will benefit from these treatments.”

Soung’s reported disclosures include AbbVie, Amgen, Arcutis, Aslan, Bristol Myers Squibb, Coval Biopharma, Dermavant, Eli Lilly, Johnson & Johnson, KoBio Labs, National Psoriasis Foundation, Novartis, Ortho Dermatologic, Oruka, Pfizer, Regeneron/Sanofi, and UCB.

References

1. Soung J, Lebwohl MG, Hebert A, et al. Durability of icotrokinra (targeted oral peptide) effects in adolescents with moderate-to-severe plaque psoriasis: one-year results from the ICONIC-LEAD study. Poster presented at: American Academy of Dermatology Annual Meeting; March 27–31, 2026; Denver, CO. Poster P73600.

2. Soung J, Lebwohl MG, Hebert A, et al. Early and durable improvements in patient-reported outcomes with the targeted oral peptide icotrokinra in adolescents with moderate-to-severe plaque psoriasis: one-year results from the ICONIC-LEAD study. Poster presented at: American Academy of Dermatology Annual Meeting; March 27–31, 2026; Denver, CO. Poster P73603.

3. Johnson & Johnson. FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide. Press release. March 18, 2026. https://www.jnj.com/media-center/press-releases/fda-approval-of-icotyde-icotrokinra-ushers-in-new-era-for-first-line-systemic-treatment-of-plaque-psoriasis-with-a-targeted-oral-peptide. Accessed March 28, 2026.