"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, vice president, gastroenterology disease area lead, Immunology, at Johnson & Johnson.1 "With over a quarter century of innovation in inflammatory bowel disease, coupled with our deep expertise in the IL [interleukin]-23 pathway, we are excited about these results and the groundbreaking potential of icotrokinra in the treatment of immune-mediated diseases."
Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor, binding to it with single-digit picomolar affinity and potent, selective inhibition of IL-23 signalling in human T cells.1
A phase 2b multicenter, randomized, placebo-controlled, dose-ranging study, ANTHEM-UC is evaluating the efficacy and safety of icotrokinra (JNJ-77242113, JNJ-2113) in patients with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy, prior biologics, and/or ozanimod or approved Janus kinase inhibitors. The study enrolled 252 patients and is evaluating 3 once-daily dosages of icotrokinra taken orally.1
Topline results from ANTHEM-UC study showed all 3 doses of once-daily icotrokinra met the primary endpoint of clinical response at week 12. According to the release from Johnson & Johnson, a response rate of 63.5% was achieved at week 12 for patients treated with the highest dose of icotrokinra versus 27% for placebo (P < .001). Additionally, 30.2% of patients treated with the highest dose of icotrokinra demonstrated clinical remission at week 12 versus 11.1% of patients who received placebo (P < .001).1
Of note, remission and response rates continued to improve through week 28. Regarding safety, results showed icotrokinra was well tolerated, with similar proportions of participants reporting at least 1 adverse event between the icotrokinra dose groups and the placebo group.1
In addition to the phase 2b ANTHEM-UC study, icotrokinra is being studied in the phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis and active psoriatic arthritis. Results presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting showed icotronika helped nearly 50% of patients at least 12 years of age with moderate to severe plaque psoriasis at 24 weeks.2
Based on these data from the ICONIC-LEAD trial as well as positive topline data from the ICONIC-ADVANCE 1 and 2 studies, which found the agent outperformed deucravacitinib for superiority in patients with moderate-to-severe plaque psoriasis, Johnson and Johnson has announced their intent to launch the ICONIC-ASCEND study, the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill compared to an injectable biologic in moderate to severe psoriasis.2
References
- Johnson & Johnson. Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients. March 10, 2025. Accessed March 10, 2025. https://www.investor.jnj.com/news/news-details/2025/Icotrokinra-meets-primary-endpoint-of-clinical-response-in-ulcerative-colitis-study-and-shows-potential-to-transform-the-treatment-paradigm-for-patients/default.aspx
- Campbell P. Icotrokinra Bests Placebo in Psoriasis, Aims for Head-to-Head with Ustekinumab. HCPLive. March 8, 2025. Accessed March 10, 2025. https://www.hcplive.com/view/icotrokinra-bests-placebo-aims-for-head-to-head-with-biologics-in-psoriasis
