Icotrokinra Demonstrates Promise in Moderate-to-Severe Plaque Psoriasis, Ulcerative Colitis
Results from multiple Phase III trials of Icotrokinra in moderate-to-severe plaque psoriasis and a Phase IIb trial in ulcerative colitis successfully met all primary endpoints.
Image Credit: Adobe Stock Images/tumeyes
Johnson & Johnson’s icotrokinra (JNJ-2113) produced positive results across multiple clinical trials evaluating the medication in the treatment of both moderate-to-severe plaque psoriasis (PsO) and ulcerative colitis (UC). In the Phase III ICONIC-LEAD and ICONIC-ADVANCE trials, icotrokinra showed promising efficacy in treating patients with moderate-to-severe PsO, whereas results from the Phase IIb ANTHEM-UC trial showed significant improvements in patients with UC.1,2
“People living with moderate-to-severe plaque psoriasis are seeking options that balance efficacy, safety, and ease of use,” said Robert Bissonnette, MD, chairman, Innovaderm Research, Montreal, Canada, ICONIC-LEAD study investigator, in a press release. “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.”
The randomized, controlled ICONIC-LEAD trial compared the efficacy and safety of icotrokinra vs. placebo. The dual primary endpoints of the study were achieving a Psoriasis Area and Severity Index (PASI) 90 response and an Investigator's Global Assessment (IGA) score of 0 or 1, with a minimum of a 2-grade improvement. Results showed that 65% of patients achieved a 0/1 IGA score and 50% achieved a PASI90 score. Additionally, 74% of patients treated with icotrokinra demonstrated continued skin clearance at week 24, with 50% also reaching an IGA score of 0 as well as a PASI100 score.
ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, which are currently in progress, are comparing the safety and efficacy of icotrokinra to both placebo and Sotyktu (deucravacitinib). The dual primary endpoints of both studies are IGA 0/1 and PASI 90 versus placebo at week 16. All secondary endpoints are a comparison of icotrokinra’s efficacy vs. Sotyktu in patients with moderate-to-severe PsO. Topline results found that the studies met both primary endpoints.1
“The robust results seen to date underscore the potential for icotrokinra to shift treatment expectations in moderate-to-severe plaque psoriasis,” said Liza O’Dowd, VP, immunodermatology disease area lead, Johnson & Johnson Innovative Medicine, in the press release. “As part of our ongoing commitment to pioneer innovations for patients, 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.”
The multicenter, randomized, placebo-controlled, dose-ranging ANTHEM-UC trial evaluated patients with moderately to severely active UC who had previously demonstrated insufficient responses or couldn’t properly tolerate conventional therapy. The primary endpoint of the study was clinical response in all icotrokinra dose groups.
Secondary endpoints included clinical remission, symptomatic remission, and endoscopic improvement at week 12. Results showed that all doses met the primary endpoint, with a 63.5% response rate for the highest dose versus 27% for placebo at week 12. Additionally, 30.2% in the highest dosing group experienced clinical remission at week 12. The treatment was well tolerated and adverse events were similar in all groups.2
“These impressive findings show the potential of icotrokinra to transform the treatment paradigm for people living with ulcerative colitis by offering a distinctive combination of therapeutic benefit, tolerability, and convenience with a once-daily oral treatment,” said Esi Lamousé-Smith, MD, PhD, VP, gastroenterology disease area lead, immunology, Johnson & Johnson, in a press release. “With over a quarter-century of innovation in inflammatory bowel disease, coupled with our deep expertise in the IL-23 pathway, we are excited about these results and the groundbreaking potential of icotrokinra in the treatment of immune-mediated diseases.”
References
1. Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis. J&J. March 8, 2025. Accessed March 11, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-potential-to-set-a-new-standard-of-treatment-in-plaque-psoriasis
2. Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients. J&J. March 10, 2025. Accessed March 11, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-meets-primary-endpoint-of-clinical-response-in-ulcerative-colitis-study-and-shows-potential-to-transform-the-treatment-paradigm-for-patients
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