Johnson & Johnson (J&J) has announced phase 2b data from two studies evaluating JNJ-4804, an investigational co-antibody therapy targeting both interleukin-23 (IL-23) and Tumor Necrosis Factor-alpha (TNF-α), in patients with moderately-to-severely active Ulcerative Colitis (UC) and Crohn’s Disease (CD) that is refractory to systemic therapies. The late-breaking presentations from the DUET-UC and DUET-CD studies were among the 32 company-sponsored abstracts being presented at Digestive Disease Week (DDW) 2026.

In both studies at Week 48, JNJ-4804 showed meaningful improvements across multiple clinical and endoscopic measures for a subpopulation of patients who are considered highly refractory and have had inadequate response to two or more systemic therapy classes.

In the overall population, JNJ-4804 demonstrated higher clinical remissionb rates (50.8 percent) and endoscopic response rates (38.1 percent) versus golimumab (25.4 percent for clinical remission, 19.8 percent for endoscopic response) at Week 48. The JNJ-4804 rates were also numerically higher than the rates achieved with guselkumab (42.5 percent for clinical remission and 33.9 percent for endoscopic response).

In the highly refractory subpopulation of patients with CD who have had inadequate response to two or more systemic therapy classes, JNJ-4804 showed clinically meaningful improvements at Week 48 across multiple clinical and endoscopic endpoints compared to golimumab and guselkumab monotherapies, and placebo. Clinical remission rates for JNJ-4804 were nearly double the highest comparator and more than 60 percent higher in endoscopic response rate.

Bruce E. Sands, MD, MS; Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine, and Chief, Division of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Health System and presenting author of the DUET-CD study, said, “Despite many treatment advances for Crohn’s Disease over the past two decades, many patients do not achieve long-term disease control with the currently available options, even after trying multiple monotherapies with different classes. The results from DUET-CD are particularly promising because they show meaningful clinical and endoscopic improvements in patients who have exhausted existing options.”

In the overall population, JNJ-4804 demonstrated superior clinical remission rates compared to golimumab, with 41 percent of JNJ-4804-treated patients achieving clinical remission at Week 48 versus golimumab (11.5 percent), and numerically higher rates than guselkumab (34 percent).

In the highly refractory subpopulation of patients with UC who have had inadequate response to two or more systemic therapy classes, JNJ-4804 showed clinically meaningful improvements at Week 48 across multiple clinical and endoscopic endpoints compared to golimumab and guselkumab monotherapies, and placebo, with the clinical remission rate for JNJ-4804 being almost 60 percent higher than the closest comparator.

Dr. Maria Abreu, Executive Director, F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai in Los Angeles and presenting author of DUET-UC, said, “There is a major unmet need for patients who either don’t respond or are no longer responding to current UC treatments. The ongoing symptoms patients face when their UC is uncontrolled can profoundly impact their lives. The improvements we saw in DUET-UC are very encouraging, offering a potential new approach for patients with few options for long-term disease control.”

In both studies, safety findings were generally consistent with the known profiles of the component monotherapies.

IBD, including UC and CD, affects millions of people worldwide. While advances in biologics and targeted therapies have improved outcomes for many patients, many individuals either no longer respond or lose response over time. It is common for patients to cycle through multiple therapies while experiencing diminishing efficacy, leading to persistent symptoms such as abdominal pain, urgency, and bleeding.

Ongoing inflammation can lead to irreversible bowel damage, hospitalisation, and surgeries. These challenges highlight a critical need for new treatments that can deliver meaningful disease control for patients who have been refractory to treatment with monotherapies.

Esi Lamousé Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson, said, “Inflammatory Bowel Disease involves multiple inflammatory pathways, which may help explain why some patients don’t respond or lose response to existing monotherapies. By targeting the orthogonal pathways of IL-23 and TNFα, JNJ-4804 yields a synergistic therapeutic approach. The results from the DUET studies highlight its potential to change the treatment landscape.”

Based on results from the phase 2b DUET studies, J&J will be initiating the phase 3 DUET ENCORE-CD trial in adults with moderately-to-severely active CD as well as the phase 3 DUET ENCORE-UC trial in adults with moderately-to-severely active UC.

With these data, in addition to results from the phase 3 FUZION study of TREMFYA (guselkumab) in perianal fistulizing Crohn’s Disease, J&J therapies account for three late-breaking abstracts featured at DDW.