Johnson & Johnson has released new results from its Phase 2b ANTHEM-UC study, showing that icotrokinra, an investigational oral peptide targeting the IL-23 receptor, maintained both therapeutic benefit and a favorable safety profile through 28 weeks in adults with moderately to severely active ulcerative colitis.
The data, which will be presented at the 2025 American College of Gastroenterology Annual Scientific Meeting, showed that all tested doses of icotrokinra (100 mg, 200 mg, and 400 mg) led to higher rates of clinical response, clinical remission, endoscopic improvement, and histologic-endoscopic mucosal improvement compared to placebo. At Week 28, the highest dose (400 mg) achieved a clinical response rate of 66.7%, clinical remission in 31.7% of patients, endoscopic improvement in 38.1%, and HEMI in 33.1%. In comparison, the placebo group reported rates of 25.4%, 9.5%, 11.1%, and 11.1% respectively.
“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, Professor of Medicine at Western University in Ontario and study investigator. “For those living with ulcerative colitis, icotrokinra could represent an important step forward in how their disease is managed.”
Adverse events and serious adverse events were reported at similar rates across all icotrokinra groups and placebo through Week 28.
“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, Vice President and Gastroenterology Disease Area Lead at 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 these findings from ANTHEM-UC (NCT06049017), Johnson & Johnson has started additional trials: ICONIC-UC Phase 3 for adults and adolescents with moderately to severely active UC; ICONIC-CD Phase 2b/3 for Crohn’s disease; as well as studies for plaque psoriasis and psoriatic arthritis. The company submitted a New Drug Application to the U.S. Food and Drug Administration in July 2025 seeking approval for use in moderate-to-severe plaque psoriasis for adults and pediatric patients aged twelve years or older.
Ulcerative colitis is described as a chronic condition where inflammation leads to ulcers in the colon lining; symptoms include urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite or weight loss, and fatigue (https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis).
Icotrokinra was jointly discovered by Protagonist Therapeutics Inc. and Janssen Biotech Inc., part of Johnson & Johnson’s pharmaceutical segment under an exclusive license agreement established in 2017 (https://www.jnj.com/media-center/press-releases/janssen-enters-into-worldwide-exclusive-license-and-collaboration-agreement-with-protagonist-therapeutics-inc-for-the-oral-interlukin-23-receptor-antagonist-drug-candidate-for-the-treatment-of-inflammatory-bowel-disease). Under this agreement—and subsequent amendments—Johnson & Johnson retains exclusive global rights for further development beyond Phase 2 trials as well as commercialization across multiple indications (https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-amendment-of-agreement-with-janssen-biotech-for-the-continued-development-and-commercialization-of-il-23-antagonists-301343621.html).
The ANTHEM-UC trial enrolled patients who had not responded adequately or were intolerant to conventional therapies or biologic treatments such as TNF antagonists or vedolizumab (https://clinicaltrials.gov/study/NCT06049017?term=ANTHEM-UC&rank=1). Participants achieving clinical response at Week 28 may continue into an extension period up to Week 76.
Johnson & Johnson continues research on icotrokinra across several immune-mediated diseases including moderate-to-severe plaque psoriasis (https://www.prnewswire.com/news-releases/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral-interleukin-23-receptor-antagonist-jnj-2113-301823039.html), psoriatic arthritis (https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-topline-results-for-phase-2b-frontier-1-clinical-trial-of-oral-il-23-receptor-antagonist-jnj-2113-pn-235-in-psoriasis-301764181.html), ulcerative colitis, and Crohn’s disease.