SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) announced new data from its Phase 2b ANTHEM-UC clinical trial evaluating icotrokinra, an investigational oral therapy for adults with moderately to severely active ulcerative colitis (UC). The 12-week results showed that all once-daily dosing regimens met the study’s primary endpoint, achieving statistically significant clinical response rates compared to placebo.
Icotrokinra is a first-in-class oral peptide designed to selectively block the IL-23 receptor, a key driver of inflammation in UC. The findings, presented at United European Gastroenterology (UEG) Week 2025, position the drug as a potential new option for patients seeking an effective, non-injectable treatment.
At Week 12, patients receiving 400 mg of icotrokinra once daily achieved a 63.5% clinical response rate versus 27% for placebo (p<0.001). Response rates were also strong in the 200 mg and 100 mg groups, reaching 58.1% and 54.7%, respectively. Across multiple secondary endpoints, the highest dose produced significantly greater rates of clinical and symptomatic remission, as well as endoscopic improvement. Meaningful symptom relief was observed as early as Week 4 in all icotrokinra groups.
Safety outcomes were consistent across treatment and placebo arms, with similar proportions of patients reporting adverse and serious adverse events.
“Ulcerative colitis can bring unpredictable and often debilitating symptoms that make even simple daily activities a challenge for many patients,” said Dr. Maria T. Abreu, Executive Director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai and study investigator. “The ANTHEM-UC study results highlight how icotrokinra can selectively target the IL-23 pathway and address the underlying inflammation using a once-daily, oral therapy that is easy for patients, while offering therapeutic benefit and a favorable safety profile.”
Following the positive Phase 2b results, Johnson & Johnson has launched its ICONIC-UC Phase 3 study in adults and adolescents with active ulcerative colitis, as well as the ICONIC-CD Phase 2b/3 study for Crohn’s disease. The company is also advancing icotrokinra in late-stage trials for plaque psoriasis and psoriatic arthritis.
“Icotrokinra marks the next chapter in our history of innovation in inflammatory bowel disease,” said Esi Lamousé-Smith, M.D., Ph.D., Vice President and Gastroenterology Disease Area Lead at Johnson & Johnson. “We look forward to initiating our Phase 3 investigation of icotrokinra in UC, with the aim of delivering meaningful improvements to patients living with this debilitating disease.”
Johnson & Johnson submitted a New Drug Application to the U.S. Food and Drug Administration in July 2025 seeking approval of icotrokinra for moderate to severe plaque psoriasis in adults and adolescents. The ongoing studies reflect the company’s continued investment in IL-23–targeted therapies aimed at improving outcomes across a range of immune-mediated inflammatory diseases.
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