ANTHEM-UC: Icotrokinra (JNJ-2113) Shows Promise for Ulcerative Colitis

Johnson & Johnson has announced positive topline results from the phase 2b ANTHEM-UC study of icotrokinra (JNJ-2113) in adults with moderately to severely active ulcerative colitis (UC).1

According to a March 10, 2025, press release from the company, the study met its primary endpoint of clinical response in all icotrokinra dose groups evaluated and demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic improvement at week 12. Comprehensive results from ANTHEM-UC will be presented at upcoming medical congresses.1

"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-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 JAK 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 ≥ 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 ≥ 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

1. 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

2. 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