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Johnson & Johnson (NYSE:JNJ) today announced Week 28 results from the Phase 2b ANTHEM-UC study of icotrokinra, a first-in-class investigational targeted oral peptide that precisely blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC). These results underscore the potential of icotrokinra to deliver a combination of therapeutic benefit and a favorable safety profile with once-daily oral dosing and will be featured among Johnson & Johnson's 23 accepted abstracts at the 2025 American College of Gastroenterology Annual Scientific Meeting (ACG).
At Week 28, icotrokinra demonstrated sustained and clinically meaningful results, with all doses (100 mg, 200 mg and 400 mg) showing higher rates of clinical responsea, clinical remissionb, endoscopic improvementc and histologic-endoscopic mucosal improvement (HEMI)d at Week 28 compared to placebo.1 These outcomes build on Week 12 data recently presented at United European Gastroenterology (UEG) Week 2025 where all doses of icotrokinra demonstrated superiority to placebo for the primary endpoint of clinical response.2
| Icotrokinra 400 mg once daily | Week 12 | Week 28 | Placebo (at Week 28) |
| Clinical response1 | 63.5 % | 66.7 % | 25.4 % |
| Clinical remission1 | 30.2 % | 31.7 % | 9.5 % |
| Endoscopic improvement1 | 36.5 % | 38.1 % | 11.1 % |
| HEMI rates1 | 28.6 % | 33.1 % | 11.1 % |
"The ANTHEM-UC results show that targeting the IL-23 pathway with a once-daily oral therapy can provide meaningful, sustained benefit and a favorable safety profile, giving healthcare providers a potential new approach to managing this challenging disease," said Vipul Jairath, MBChB, DPhil, Professor of Medicine at Western University in Ontario, and study investigator.e "For those living with ulcerative colitis, icotrokinra could represent an important step forward in how their disease is managed."
Similar proportions of participants reported adverse events and serious adverse events through Week 28 across all icotrokinra dose groups and the placebo group.1
"These exciting results show how we are harnessing our deep understanding of the IL-23 pathway to advance innovative treatments for inflammatory bowel disease that address the daily needs of patients," said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson. "With Phase 3 development now underway in both adult and adolescent patients, our aim is to establish icotrokinra as a promising therapy that could transform the treatment paradigm in ulcerative colitis and bring patients a potential new option."
Based on results from the Phase 2b ANTHEM-UC study, Johnson & Johnson has initiated the ICONIC-UC Phase 3 protocol in adults and adolescents with moderately to severely active UC as well as the ICONIC-CD Phase 2b/3 protocol in adults with moderate to severely active Crohn's disease. Icotrokinra is also being studied in the pivotal Phase 3 ICONIC program in moderate-to-severe plaque psoriasis and the ICONIC-PSA 1 and ICONIC-PSA 2 studies in active psoriatic arthritis. A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in July 2025 seeking the first approval of icotrokinra for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis.
Posted In: JNJ
