Icotrokinra Demonstrates Meaningful Skin Clearance in Moderate-to-Severe Plaque Psoriasis

New data from the phase 3 ICONIC-LEAD clinical trial demonstrate that once daily icotrokinra (JNJ-2113; Johnson & Johnson), a first-in-class, investigational targeted oral peptide, led to significant skin clearance and a positive safety profile in adults and adolescents 12 years and older with moderate-to-severe plaque psoriasis. The results were presented as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting.¹

Plaque psoriasis can cause a long-term burden for patients. | Image Credit: © IIIRusya - stock.adobe.com

“People living with moderate-to-severe plaque psoriasis are seeking options that balance efficacy, safety, and ease of use,” Robert Bissonnette, MD, chairman, Innovaderm Research and study investigator in the ICONIC-LEAD trial, said in a news release from Johnson & Johnson. “These study results are promising and show the potential for treatment with icotrokinra to offer patients the unique combination of complete skin clearance and a favorable safety profile in a once-daily pill.”¹

Meaningful, positive results were observed throughout the ICONIC-LEAD study. Approximately two-thirds of patients treated with icotrokinra, which works to selectively block the IL-23 receptor, achieved an Investigator’s Global Assessment (IGA) score of 0/1, indicating clear or almost clear skin. Furthermore, 50% of treated patients experienced a Psoriasis Area and Severity Index (PASI) 90 response, compared with 8% and 4% receiving placebo, respectively, at week 16.¹

At week 24 of the trial, study investigators observed sustained skin clearance improvement; 74% of patients treated with icotrokinra achieved IGA 0/1, and 65% achieved PASI 90. In addition, almost half of icotrokinra-treated patients achieved completely clear skin, with 46% reaching IGA 0 and 40% achieving PASI 100. There were similar rates of adverse events (AEs) between the icotrokinra (49%) and placebo groups (49%), with no novel safety signals to report, according to the study authors.¹

Corresponding topline results from the phase 3 ICONIC-ADVANCE 1&2 studies indicated that investigators met co-primary end points of IGA 0/1 and PASI 90 versus placebo at week 16. Secondary end points indicating measured superiority at weeks 16 and 24 were also met for icotrokinra in comparison with deucravacitinib (Sotyktu; Bristol Myers Squibb) in patients with moderate-to-severe plaque psoriasis. These positive results have led to Johnson & Johnson initiating the phase 3 ICONIC-ASCEND trial, which stands to be the first-ever head-to-head trial comparing an oral pill, icotrokinra, and an injectable biologic, ustekinumab (Stelara; Janssen Biotech).¹

The burden of psoriasis can be immense and challenging for patients affected. Among US citizens with psoriasis, 49% go untreated, which is a major concern and necessitates more convenient and effective treatment options. In the form of a once-daily oral pill, icotrokinra has the potential to transform the treatment paradigm for patients with plaque psoriasis and improve their quality of life. If approved by the FDA, icotrokinra stands to make prescribing and counseling for patients with plaque psoriasis more optimized with the availability of a convenient treatment option.^1,2

“The robust results seen to date underscore the potential for icotrokinra to shift treatment expectations in moderate-to-severe plaque psoriasis,” Liza O’Dowd, vice president, Johnson & Johnson Innovative Medicine, said in the news release. “We are proud to advance this first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, which shows promise as a potential first-line systemic therapy for the treatment of plaque psoriasis.”¹

REFERENCES

1. Johnson & Johnson. Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis. News Release. Released March 8, 2025. Accessed March 10, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-potential-to-set-a-new-standard-of-treatment-in-plaque-psoriasis

2. McGovern G. Pharmacists play a crucial role monitoring patients with psoriasis and psoriatic arthritis. Pharmacy Times^®. Published February 14, 2025. Accessed March 10, 2025. https://www.pharmacytimes.com/view/pharmacists-play-a-crucial-role-monitoring-patients-with-psoriasis-and-psoriatic-arthritis