Key Takeaways
- Strong Phase III efficacy data: Icotrokinra met primary endpoints across all four pivotal trials, demonstrating significant skin clearance in patients with plaque psoriasis.
- Broad New Drug Application (NDA) submission scope: Johnson & Johnson’s NDA covers use in adults and adolescents aged 12 and older with moderate to severe plaque psoriasis.
- Favorable safety profile: Pooled trial data showed similar adverse event rates between icotrokinra and placebo, supporting its tolerability.
Johnson & Johnson has submitted a New Drug Application (NDA) to the FDA for icotrokinra, a first-in-class investigational oral peptide that selectively blocks the IL-23 receptor, for the treatment of moderate to severe plaque psoriasis in adults and adolescents aged 12 years and older. According to the company, the submission was based on results from four pivotal Phase III trials—ICONIC-LEAD (NCT06095115), ICONIC-TOTAL (NCT06095102), and ICONIC-ADVANCE 1 (NCT06143878) and 2 (NCT06220604)—which showed that icotrokinra demonstrated significant skin clearance.1
How Does Icotrokinra Compare to Existing Plaque Psoriasis Therapies?
"The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences," said Liza O'Dowd, MD, VP, immunodermatology, respiratory disease area lead at, Johnson & Johnson Innovative Medicine, in a press release.
ICONIC-LEAD Trial Overview
The randomized, multicenter, double-blind, placebo-controlled ICONIC-LEAD trial evaluated the efficacy and safety of icotrokinra in 684 patients. The dual primary endpoints of the trial were the percentage of patients achieving an investigator’s global assessment score of 0 or 1 and the percentage of patients achieving psoriasis area and severity index (PASI) 90 response at week 16.2 Results showed that the trial met its primary endpoint, with patients achieving clear or almost clear skin as well as PASI 90.1
ICONIC-TOTAL Special Area Trial
The multicenter, randomized, double-blind, placebo-controlled ICONIC-TOTAL evaluated the efficacy of icotrokinra in 311 patients with plaque psoriasis affecting special areas such as the scalp, genital, and/or palms of the hands and the soles of the feet. The primary endpoint of the trial was the percentage of patients achieving an investigator’s global assessment score of 0 or 1 at week 16.3
ICONIC-ADVANCE Trials and Active Comparator Data
The multicenter, randomized, double-blind, placebo controlled, deucravacitinib active comparator-controlled ICONIC‑ADVANCE 1 trial compared icotrokinra versus placebo and the oral biologic deucravacitinib in 774 patients. The dual primary endpoints of the trial were the percentage of patients achieving an investigator’s global assessment score of 0 or 1 as well as the percentage of patients achieving PASI 90 at week 16.4 The ICONIC-ADVANCE 2 trial mirrored ICONIC-ADVANCE 1 in trial design.1,5
Safety Data
Pooled safety analysis revealed comparable adverse event (AE) rates between treatment and placebo groups, with rates of 49.1% and 51.9%, respectively. Additionally, the safety profile was consistent across all trials.1
Psoriasis Prevalence and Health Disparities
According to the National Psoriasis Foundation, psoriasis affects approximately 3% of U.S. adults aged 20 years and older, with around 600,000 people currently undiagnosed. Prevalence is estimated at 2.8% in males and 3.2% in females. Rates vary by race and ethnicity, likely due in part to disparities in diagnosis and access to care. White individuals have the highest prevalence at 3.6%, followed by Asian individuals at 2.5%, and Black individuals at 1.5%. Prevalence increases with age, peaking in people in their 50s, before decreasing in people aged 70 years and older.6
Given the breadth and depth of our studies, along with the robust clinical results reported to date, we are confident that icotrokinra has the potential to transform how physicians and patients think about plaque psoriasis care, establishing a new standard in the treatment of this immune-mediated disease,” continued O’Dowd, in the press release.
References
- Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis. PR Newswire. July 21, 2025. Accessed July 21, 2025. https://www.prnewswire.com/news-releases/johnson--johnson-seeks-first-icotrokinra-us-fda-approval-aiming-to-revolutionize-treatment-paradigm-for-adults-and-adolescents-with-plaque-psoriasis-302509221.html
- A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis (ICONIC-LEAD). Clinicaltrials.gov. Accessed July 21, 2025. https://clinicaltrials.gov/study/NCT06095115
- 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. Accessed July 21, 2025. https://clinicaltrials.gov/study/NCT06095102
- A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis. Clinicaltrials.gov. Accessed July 21, 2025. https://clinicaltrials.gov/study/NCT06143878
- A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2). Clinicaltrials.gov. Accessed July 21, 2025. https://clinicaltrials.gov/study/NCT06220604
- Prevalence of Psoriasis. National Psoriasis Foundation. Accessed July 21, 2025. https://www.psoriasis.org/prevalence-of-psoriasis/
