- Icotrokinra is a targeted oral peptide blocking the IL-23 receptor.
- Phase 2b ANTHEM-UC study results show sustained benefits at Week 28.
- Phase 3 trials are underway for ulcerative colitis and Crohn's disease.
- A New Drug Application was submitted to the FDA in July 2025.
Study Overview
Johnson & Johnson announced results from the Phase 2b ANTHEM-UC study of icotrokinra, a first-in-class investigational oral peptide targeting the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC). The study highlights icotrokinra's potential to offer therapeutic benefits and a favorable safety profile with once-daily dosing.
Clinical Results
At Week 28, icotrokinra showed sustained and clinically meaningful results across all doses (100 mg, 200 mg, and 400 mg), with higher rates of clinical response, clinical remission, endoscopic improvement, and histologic-endoscopic mucosal improvement compared to placebo. These findings build on Week 12 data where icotrokinra demonstrated superiority to placebo for clinical response.
Safety Profile
Adverse events and serious adverse events were reported in similar proportions across all icotrokinra dose groups and the placebo group through Week 28, indicating a favorable safety profile.
Future Developments
Based on the Phase 2b results, Johnson & Johnson has initiated the ICONIC-UC Phase 3 protocol for adults and adolescents with UC and the ICONIC-CD Phase 2b/3 protocol for Crohn's disease. Icotrokinra is also being studied in the ICONIC program for plaque psoriasis and psoriatic arthritis. A New Drug Application was submitted to the FDA in July 2025 for treating moderate to severe plaque psoriasis in patients aged 12 and older.
