Johnson & Johnson has released new long-term data from its Phase 3 ICONIC-TOTAL study, evaluating the investigational oral peptide icotrokinra in adults and adolescents with plaque psoriasis affecting challenging areas such as the scalp, genitals, hands, and feet. The results were presented at the 2025 Fall Clinical Dermatology Conference.
The study followed participants for 52 weeks and included both adults and patients aged 12 years or older with at least moderate psoriasis in high-impact body sites. According to the company, icotrokinra showed sustained skin clearance across these difficult-to-treat areas. Specifically, 72% of patients with scalp psoriasis achieved a scalp-specific Investigator’s Global Assessment (ss-IGA) score of 0 or 1, indicating clear or almost clear skin. In genital psoriasis cases, 85% reached a Physician’s Global Assessment of Genitalia (sPGA-G) score of 0 or 1.
For those with hand and foot involvement—a smaller group within the study—the proportion achieving clear or almost clear skin increased from 42% at week 16 to 62% by week 52.
“Many of the patients in my practice experience significant distress when psoriasis affects sensitive areas such as the scalp, genitals, hands, and feet,” said Edward (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.”
Overall response rates were maintained through one year of treatment: two-thirds of participants on once-daily icotrokinra achieved clear or almost clear skin by week 52. Rates were similar between those who received icotrokinra throughout the year and those who switched from placebo after week 16. Adverse event rates remained stable compared to earlier time points in the trial.
“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,” said Liza O’Dowd, MD, Vice President, Immunodermatology and Respiratory Disease Areas Lead at Johnson & Johnson Innovative Medicine. “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.”
Icotrokinra is designed to block IL-23 receptor activity linked to inflammation in moderate-to-severe plaque psoriasis as well as other immune-mediated diseases like ulcerative colitis and Crohn’s disease. The compound was jointly discovered by Protagonist Therapeutics and Janssen Biotech under an ongoing license agreement established in 2017.
The broader Phase 3 clinical program includes several trials evaluating icotrokinra’s efficacy against placebo as well as active comparators such as deucravacitinib and ustekinumab for conditions including plaque psoriasis (https://classic.clinicaltrials.gov/ct2/show/NCT06095115), psoriatic arthritis (https://clinicaltrials.gov/study/NCT06878404), ulcerative colitis (https://clinicaltrials.gov/study/NCT07196748), and Crohn’s disease (https://clinicaltrials.gov/study/NCT07196722).
Plaque psoriasis is a chronic immune-mediated condition characterized by inflamed patches on various parts of the body; it affects about eight million people in America alone according to estimates from patient advocacy organizations (https://www.psoriasis.org/content/statistics). Nearly one-quarter have moderate-to-severe forms impacting quality of life—especially when lesions occur on visible or sensitive sites such as scalp or genitals (https://www.psoriasis.org/high-impact-sites).
Icotrokinra remains investigational pending further research outcomes and regulatory review.
Johnson & Johnson holds exclusive worldwide rights for advanced development stages and commercialization under its agreement with Protagonist Therapeutics.
For more information about Johnson & Johnson’s work in innovative medicine visit https://www.jnj.com/.