Johnson & Johnson’s JNJ-4804 shows promising Phase 2b results in refractory inflammatory bowel disease

Johnson & Johnson has presented Phase 2b data from two studies evaluating JNJ-4804, an investigational co-antibody therapy that simultaneously blocks the IL-23 and TNF-alpha inflammatory pathways, in patients with moderately to severely active ulcerative colitis and Crohn’s disease who have failed multiple prior systemic therapies. The data were presented as late-breaking abstracts at Digestive Disease Week 2026 in Chicago and support advancement of the programme into Phase 3 trials.

JNJ-4804 is the first and only fixed-dose co-antibody designed to deliver molecular synergy in inflammatory bowel disease by targeting two complementary but distinct inflammatory pathways simultaneously, an approach that may help explain why some patients fail to respond to existing monotherapies over time.

In the DUET-CD study, JNJ-4804 achieved clinical remission in 50.8% of patients in the overall Crohn’s disease population at Week 48, compared with 25.4% for golimumab and 42.5% for guselkumab. Endoscopic response rates followed a similar pattern, with JNJ-4804 outperforming both comparators. In the highly refractory subpopulation, defined as patients who had failed two or more systemic therapy classes, clinical remission rates with JNJ-4804 were nearly double those of the highest comparator, with endoscopic response rates more than 60% higher.

Bruce Sands, Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai and presenting author of DUET-CD, highlighted the significance of results in this difficult-to-treat group: “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 DUET-UC study, JNJ-4804 achieved clinical remission in 41.0% of patients in the overall ulcerative colitis population at Week 48, compared with 11.5% for golimumab and 34.0% for guselkumab. In the highly refractory subpopulation, the clinical remission rate with JNJ-4804 was almost 60% higher than the closest comparator across multiple clinical and endoscopic endpoints.

Maria Abreu, Executive Director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai, described the results as offering genuine hope for a population with few remaining options: “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.”

Esi Lamousé Smith, Vice President and Gastroenterology Disease Area Lead at Johnson & Johnson Immunology, explained the scientific rationale underpinning the co-antibody approach: “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 TNF-alpha, JNJ-4804 yields a synergistic therapeutic approach. The results from the DUET studies highlight its potential to change the treatment landscape.”

Safety findings across both studies were broadly consistent with the known profiles of the individual component monotherapies. Based on the Phase 2b results, Johnson & Johnson will now initiate the Phase 3 DUET ENCORE-CD and DUET ENCORE-UC trials in adults with moderately to severely active Crohn’s disease and ulcerative colitis respectively.

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Related Topics and Keywords

bowel disease, inflammatory bowel disease, Johnson & Johnson's, Johnson & Johnson's JNJ-4804, Phase 2b results