Johnson & Johnson has announced new 12-week data from its Phase 2b ANTHEM-UC study of icotrokinra, an investigational oral peptide that targets the IL-23 receptor, in adults with moderately to severely active ulcerative colitis. The company reported that all once-daily icotrokinra dose groups met the primary endpoint of clinical response at Week 12 and showed improvements over placebo across key secondary measures.
At Week 12, patients receiving a daily dose of 400 mg icotrokinra had a clinical response rate of 63.5% compared to 27% for those on placebo. The response rates for the 200 mg and 100 mg doses were 58.1% and 54.7%, respectively. In addition to clinical response, higher proportions of patients in the treatment groups achieved clinical remission, symptomatic remission, and endoscopic improvement compared to placebo.
Rates of adverse events and serious adverse events through Week 12 were similar among all icotrokinra groups and the placebo group.
“Ulcerative colitis can bring unpredictable and often debilitating symptoms that make even simple daily activities a challenge for many patients,” said Maria T. Abreu, M.D., Executive Director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai in Los Angeles 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. This approach reflects the continued progress in translating scientific advances into innovations for people living with ulcerative colitis.”
Based on these findings, Johnson & Johnson has begun enrolling participants in two further studies: ICONIC-UC Phase 3 (for adults and adolescents with ulcerative colitis) and ICONIC-CD Phase 2b/3 (for adults with Crohn’s disease). Details about these ongoing trials are available on ClinicalTrials.gov under identifiers NCT07196748 (https://clinicaltrials.gov/study/NCT07196748) for ulcerative colitis and NCT07196722 (https://clinicaltrials.gov/study/NCT07196722) for Crohn’s disease.
Icotrokinra is also being tested in late-stage trials for moderate-to-severe plaque psoriasis as part of the ICONIC program as well as studies targeting psoriatic arthritis.
A New Drug Application was submitted to the U.S. Food and Drug Administration in July 2025 seeking approval for icotrokinra as a treatment option for adults and children aged twelve years or older with moderate to severe plaque psoriasis.
“Icotrokinra marks the next chapter in our history of innovation in inflammatory bowel disease, building on our deep scientific expertise in the IL-23 pathway to develop targeted solutions that address the complexity of disease biology and meet the real-world needs of patients,” said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology 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.”
The ANTHEM-UC trial (NCT06049017; https://clinicaltrials.gov/study/NCT06049017?term=ANTHEM-UC&rank=1) evaluated three once-daily dosages taken orally by individuals who had not responded adequately or could not tolerate standard therapies or prior biologics.
Ulcerative colitis is described as a chronic condition affecting the large intestine where inflammation leads to ulcers producing pus and mucus; common symptoms include urgent bowel movements, rectal bleeding or bloody stool, diarrhea persisting over time, abdominal pain, weight loss or fatigue according to information from patient advocacy organizations such as Crohn’s & Colitis Foundation (https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis).
Icotrokinra was developed under a license agreement between Protagonist Therapeutics Inc. and Janssen Biotech Inc., which is part of Johnson & Johnson. Under this collaboration established since 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), both companies have worked together on discovering next-generation compounds targeting diseases mediated by IL-23 signaling pathways.
Further amendments expanded development rights allowing Johnson & Johnson exclusive worldwide rights beyond early-phase research stages (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).
Results from previous studies have shown promising outcomes for icotrokinra across several autoimmune conditions including 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;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).
Johnson & Johnson retains responsibility for future development phases as well as potential commercialization efforts related to icotrokinra across multiple indications.