Icotrokinra Shows High Rates of Skin Clearance in Scalp, Genital Psoriasis
In a phase 3 study, 57% of patients treated with icotrokinra achieved an Investigator's Global Assessment score of 1 or 0 and a grade 2 or more improvement at week 16.
Positive results have been announced from a phase 3 trial evaluating the efficacy and safety of icotrokinra in patients 12 years of age and older with plaque psoriasis affecting high-impact skin sites, Johnson & Johnson announced in a release.1 The data was presented at the 2025 Society for Investigative Dermatology Annual Meeting.
Icotrokinra Show High Rates of Skin Clearance in Scalp, Genital Psoriasis / ksu_ok - stock.adobe.com
Results from ICONIC-TOTAL (NCT06095102) showed that icotrokinra met its primary endpoint of the percentage of patients achieving a score of 1 to 0 and grade 2 or more improvement on the Investigator's Global Assessment (IGA) at week 16. The therapy also demonstrated a favorable safety profile, with a similar number of adverse events in the treatment and placebo groups.
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"While plaque psoriasis can appear in any location on the body, most high-impact skin sites affect areas critical for mobility, personal care, and intimacy, and can be very challenging to treat effectively,” Melinda Gooderham, MSc, MD, FRCPC, an investigator on the study, said in a release.1 “Results from the ICONIC-TOTAL study demonstrate impressive rates of skin clearance in these difficult-to-treat areas and show the potential for treatment with icotrokinra to offer patients a novel therapeutic option that aligns with their treatment needs and preferences."
Icotrokinra is an investigational oral peptide that selectively blocks the IL-23 receptor. By binding to the receptor, icotrokinra inhibits signaling to T cells. IL-23 is responsible for the inflammatory response in moderate to severe plaque psoriasis, ulcerative colitis and many other autoimmune disorders. The therapy was jointly discovered by Protagonist Therapeutics, Johnson & Johnson, and Janssen Biotech.
ICONIC-TOTAL is a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial evaluating the efficacy and safety of icotrokinra in patients 12 years of age and older with plaque psoriasis affecting high-impact skin sites, including the scalp, genitals, and palms of the hands or soles of the feet. The study cohort included 311 patients with plaque psoriasis for at least 26 weeks prior to the study, and a total body surface area (BSA) of 1% or greater at both screening and baseline. Patients received either icotrokinra from week 0 to week 156 or placebo from week 0 to week 16, after which they received the therapy through week 156.
The study found that 57% of patients who received icotrokinra achieved an IGA score of 1 or 0 and a grade 2 or more improvement at week 16, compared to 6% of patients who received the placebo. Of the patients with scalp psoriasis, 66% who received the therapy met the primary endpoint, compared to 11% who received placebo. Of patients with genital psoriasis, 77% who received the therapy met the primary endpoint, compared to 21% who received placebo.
Additionally, of the patients in the smaller subgroup with hand and/or foot psoriasis, 42% who received icotrokinra achieved a score of 1 or 0 on the hand and/or foot Physician's Global Assessment, compared to 26% who received placebo.
"When plaque psoriasis affects sensitive areas of the body, patients often experience unique challenges that can have a profound impact on their daily lives," Liza O'Dowd, MD, vice president of Immunodermatology Disease Area Lead at Johnson & Johnson Innovative Medicine, said in a release.1 "These new findings build upon the impressive scalp psoriasis results seen in ICONIC-LEAD and strengthen the breadth of data demonstrating the potential for icotrokinra to shift the treatment paradigm in moderate-to-severe plaque psoriasis, by offering a combination of skin clearance and favorable safety in a once daily pill."
READ MORE: Dermatology Resource Center
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