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New trial results reveal icotrokinra's effectiveness in achieving significant skin clearance for challenging scalp and genital psoriasis.
According to results from the phase 3 ICONIC-TOTAL randomized controlled trial (NCT06095102), icotrokinra (JNJ-2113), a first-in-class targeted oral peptide, meaningfully achieved the primary end point of the study, with 57% of patients achieving an Investigator’s Global Assessment (IGA) score of 0/1—indicating clear or almost clear skin—and a 2 or higher grade improvement in difficult-to-treat scalp and genital psoriasis from baseline at week 16, compared with 6% of patients who received placebo (P < .001).1-3
Psoriasis on the scalp, genitals, or hands can cause immense burdens for patients. | Image Credit: © SergeVo - stock.adobe.com
The results, published in a news release from Johnson & Johnson and presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting, indicate high rates of skin clearance in patients with scalp psoriasis treated with icotrokinra, with 66% of these patients achieving a scalp-specific IGA score of 0/1 compared with 11% receiving placebo (P < .001) at week 16. Additionally, in patients with genital psoriasis, 77% treated with icotrokinra achieved a static Physician’s Global Assessment of Genitalia (sPGA-G) score of 0.1, compared with 21% receiving placebo (P < .001).1
A smaller subset of patients with hand or foot psoriasis were enrolled in the trial and treated with icotrokinra. At week 16, a numerically higher rate of skin clearance was observed among treated patients, with 42% reaching a hand and/or foot PGA score of 0/1, compared with 26% receiving placebo. Importantly, across the entire study population, a favorable safety profile was found, with a similar proportion of patients in the icotrokinra and placebo groups experiencing adverse events (AEs; 50% and 42%, respectively) and serious AEs (0.5% and 1.9%, respectively). No novel safety signals were observed, according to the researchers.1
“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, ICONIC-TOTAL study investigator, said in a news release from Johnson & Johnson, noting that 80% of psoriasis patients experience scalp involvement. “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.”1
Other clinical trials have evaluated icotrokinra in other therapeutic areas, demonstrating broad effectiveness and promise in the psoriasis space. In ICONIC-LEAD, icotrokinra induced meaningful skin clearance, with a correspondingly positive safety profile, in adults and adolescents 12 years and older with moderate-to-severe plaque psoriasis. These results, presented at the 2025 American Academy of Dermatology Annual Meeting, showed strong effectiveness in clearing psoriasis with icotrokinra, with two-thirds of patients who were treated achieving an IGA score of 0/1. In addition, 50% of patients treated with icotrokinra had a Psoriasis Area and Severity Index (PASI) response, compared with 8% receiving placebo.3
Trial Name: A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet) (ICONIC-TOTAL)
ClinicalTrials.gov ID: NCT06095102
Sponsor: Janssen Research & Development, LLC
Estimated Completion Date: June 10, 2027
In a critical observation, investigators found that icotrokinra led to sustained psoriasis improvement and skin clearance at week 24, indicating the long-term effectiveness of the treatment. Remarkably, almost half of these patients achieved completely clear skin. As icotrokinra continues along the clinical development pipeline, ensuring patients treated can live healthy, unburdened lives far into the future with treatment will be critical, and investigators will likely focus on how the length of time that icotrokinra provides skin clearance can be extended.3
“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 and immunodermatology disease area lead at Johnson & Johnson Innovative Medicine, said in the news release. “These new findings…[demonstrate] 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.”1
