Icotrokinra Shows Durable Efficacy for PsO, Including Hard-to-Treat Areas, in 1-Year ICONIC-TOTAL Trial

New long-term data from Johnson & Johnson’s phase 3 ICONIC-TOTAL study highlight the durable efficacy and favorable safety of icotrokinra, an investigational first-in-class targeted oral peptide that selectively blocks the IL-23 receptor.¹ Presented at the 2025 Fall Clinical Dermatology Conference in Las Vegas, Nevada, these results underscore icotrokinra’s potential as a transformative oral therapy for patients with moderate-to-severe plaque psoriasis, particularly those with disease affecting challenging and high-impact sites such as the scalp, genitals, hands, and feet.

Durable Clearance Across Difficult-to-Treat Areas

Through 52 weeks of treatment, icotrokinra achieved high and sustained rates of site-specific clearance. Among patients with scalp psoriasis, 72% reached a scalp-specific Investigator’s Global Assessment (ss-IGA) score of 0/1 (clear or almost clear), and 57% achieved complete clearance (ss-IGA 0). In patients with genital psoriasis, 85% achieved clear or almost clear skin (sPGA-G 0/1), and 73% achieved full clearance.

For the subset of patients with hand or foot psoriasis, response rates improved steadily over time. Approximately 42% achieved clear or almost clear skin at Week 16, increasing to 62% by Week 52, as measured by the hand/foot Physician’s Global Assessment (hf-PGA).

“Many of the patients in my practice experience significant distress when psoriasis affects sensitive areas such as the scalp, genitals, hands, and feet,” said Ted Lain, MD, MBA, executive director of the Austin Institute for Clinical Research in Austin, Texas, and study investigator. “The durable response rates observed in the ICONIC-TOTAL study show that icotrokinra has the potential to be a meaningful new option for effectively managing moderate-to-severe plaque psoriasis long-term in both adults and adolescents.”¹

Strong Overall Efficacy and Safety Profile

Icotrokinra’s efficacy extended beyond localized disease. Overall, 67% of patients achieved clear or almost clear skin (IGA 0/1) and 44% achieved completely clear skin (IGA 0) by Week 52. Importantly, these rates were maintained through 1 year and were consistent between patients treated continuously with icotrokinra and those who switched from placebo to icotrokinra after 16 weeks (67% vs. 68%, respectively).

The safety profile remained favorable over 52 weeks, with adverse event and serious adverse event rates comparable to earlier data through Week 16. No new safety signals emerged, reinforcing icotrokinra’s tolerability as a once-daily oral therapy.

“The new long-term data from ICONIC-TOTAL adds to the robust findings seen across several studies this year, including the recently reported ICONIC-LEAD 52-week data,” Liza O’Dowd, MD, vice president and disease area leader for immunodermatology and respiratory at Johnson & Johnson Innovative Medicine, said in a statement. “Psoriasis that affects high-impact skin sites often results in greater physical discomfort for patients due to the sensitivity of these areas. Icotrokinra is being developed with the goal of setting a new standard of treatment that offers patients the precision of a targeted therapy, high level skin clearance and favorable safety profile with the ease of a once daily pill.” ¹

The ICONIC Development Program

Icotrokinra (JNJ-77242113, JNJ-2113) is the first targeted oral peptide designed to precisely block the IL-23 receptor, a key driver of inflammation in psoriasis and other immune-mediated diseases. The drug binds the IL-23 receptor with single-digit picomolar affinity, offering precise and potent inhibition of IL-23 signaling in human T cells.

The ICONIC clinical development program encompasses multiple late-stage trials evaluating icotrokinra (JNJ-2113) in both adult and adolescent populations. Alongside ICONIC-TOTAL, the ICONIC-LEAD study evaluates efficacy and safety in moderate-to-severe plaque psoriasis, while ICONIC-ADVANCE 1 and 2 compare icotrokinra against both placebo and deucravacitinib, another oral psoriasis therapy.²

Future studies—including ICONIC-ASCEND, ICONIC-PsA 1 and 2, ICONIC-UC, and ICONIC-CD—aim to expand evaluation into psoriatic arthritis, ulcerative colitis, and Crohn’s disease, further exploring the potential of IL-23 receptor inhibition across immune-mediated conditions.

References

1. Icotrokinra long-term results affirm promise of targeted oral peptide with high rates of durable skin clearance and favorable safety profile in difficult-to-treat scalp and genital psoriasis. Johnson & Johnson. News release. Published October 24, 2025. Accessed October 24, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-long-term-results-affirm-promise-of-targeted-oral-peptide-with-high-rates-of-durable-skin-clearance-and-favorable-safety-profile-in-difficult-to-treat-scalp-and-genital-psoriasis

2. Icotrokinra shows superiority to deucravacitinib in first reported head-to-head trials reinforcing promise of novel targeted oral peptide for treatment of plaque psoriasis. Press release. Johnson & Johnson. Published September 17, 2025. Accessed October 24, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-shows-superiority-to-deucravacitinib-in-first-reported-head-to-head-trials-reinforcing-promise-of-novel-targeted-oral-peptide-for-treatment-of-plaque-psoriasis