Johnson & Johnson (JNJ) on Monday reported positive Week 28 results from its Phase 2b ANTHEM-UC study evaluating icotrokinra in adults with moderately to severely active ulcerative colitis (UC).
At Week 28, icotrokinra showed sustained and clinically meaningful efficacy, with all doses demonstrating higher rates of clinical response, clinical remission, endoscopic improvement, and histologic-endoscopic mucosal improvement (HEMI) compared with placebo.
These findings build on Week 12 data presented at United European Gastroenterology (UEG) Week 2025, where all icotrokinra doses showed superiority to placebo for the study's primary endpoint of clinical response.
Based on the ANTHEM-UC study results, Johnson & Johnson has initiated the ICONIC-UC Phase 3 trial in adults and adolescents with moderately to severely active UC, as well as the ICONIC-CD Phase 2b/3 study in adults with moderately to severely active Crohn's disease.
Icotrokinra is also under evaluation in the pivotal Phase 3 ICONIC program for moderate-to-severe plaque psoriasis and in the ICONIC-PSA 1 and ICONIC-PSA 2 studies for active psoriatic arthritis.
A New Drug Application (NDA) for icotrokinra was submitted to the U.S. Food and Drug Administration (FDA) in July 2025, seeking approval for the treatment of individuals aged 12 years and older with moderate to severe plaque psoriasis.
Johnson & Johnson stock had closed Friday's trading at $190.40, down 1.08%.
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