Johnson & Johnson Reports Positive Phase 2b Results For Icotrokinra In Ulcerative Colitis

(RTTNews) - Johnson & Johnson (JNJ) on Tuesday announced additional Week 12 results from the Phase 2b ANTHEM-UC study of icotrokinra in adults with moderately to severely active ulcerative colitis (UC). The study met its primary endpoint of clinical response, with 36.5% of patients treated with the highest dose achieving endoscopic improvement at Week 12.

At Week 12, patients treated with 400 mg of icotrokinra achieved a clinical response rate of 63.5% versus 27% for placebo, while response rates were 58.1% and 54.7% for patients treated with 200 mg and 100 mg doses, respectively.

Based on these results, the company has initiated the ICONIC-UC Phase 3 protocol in adults and adolescents with moderately to severely active UC and the ICONIC-CD Phase 2b/3 protocol in adults with moderately to severely active Crohn's disease.

Icotrokinra is also being evaluated in the pivotal Phase 3 ICONIC program in moderate-to-severe plaque psoriasis and in 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.