Sanofi and Teva: Up to 58% Remission with Duvakitug at 44 Weeks
The two laboratories presented on October 20, 2026, at UEG Week 2026 in Barcelona the results of the long-term extension of the phase 2b RELIEVE UCCD trial in ulcerative colitis and Crohn's disease. These data cover 130 patients and concern a monoclonal antibody already engaged in four phase 3 trials.
Remission and Response Rates Superior at the 900 mg Dose
Duvakitug is an experimental human monoclonal antibody targeting TL1A, a protein that amplifies inflammation and could promote fibrosis in these two chronic inflammatory bowel diseases. The study followed 130 patients (72 with ulcerative colitis, 58 with Crohn's disease) who responded to treatment during the 14-week induction phase. They were then randomly assigned to two doses, 450 mg or 900 mg, administered subcutaneously every four weeks.
In ulcerative colitis, the clinical remission rate (primary endpoint) reached 47% at 450 mg and 58% at 900 mg at week 44. Clinical response was 82% and 87%, endoscopic improvement 59% and 63%.
In Crohn's disease, endoscopic response (primary endpoint) was 41% at 450 mg and 55% at 900 mg. Clinical response was 81% and 87%, clinical remission 81% and 84%. According to the laboratories, these results, numerically higher at the higher dose, are consistent with a dose effect.
Biomarker analyses from the induction phase were also presented: duvakitug reduced markers of multiple inflammatory pathways and, in patients with Crohn's disease, markers of tissue remodeling.
Descriptive Data on Small Sample Sizes, Unchanged Safety Profile
The results are presented by the laboratories as descriptive. Sample sizes per arm ranged from 27 to 38 patients, and 95% confidence intervals were wide: 30% to 65% for clinical remission at 450 mg in ulcerative colitis, 25% to 62% for endoscopic response at 450 mg in Crohn's disease. The maintenance phase, conducted double-blind, compares two doses of the product against each other and involves only patients who were already responders at induction.
Regarding safety, the safety profile is described as consistent with that of the induction phase, with no new signal identified. The most frequent adverse events (at least 5% of patients) were, in ulcerative colitis, upper respiratory tract infections and rhinopharyngitis; in Crohn's disease, disease flares, hypertension, anemia, and cases of influenza were added. The majority of these events were mild or moderate in intensity.
Treatment discontinuations due to adverse events affected 4% and 2% of patients in ulcerative colitis (450 mg and 900 mg), and 6% in each arm in Crohn's disease. The efficacy and safety of duvakitug have not been evaluated by any regulatory authority.
The product is the subject of phase 3 trials SUNSCAPE-1 and SUNSCAPE-2 in ulcerative colitis, and STARSCAPE-1 and STARSCAPE-2 in Crohn's disease. Sanofi and Teva have also launched the phase 2 AURALIGHT trial in hidradenitis suppurativa and plan a phase 2 study in fibrostenotic Crohn's disease. The two groups equally share the costs of global development as well as net profits and losses on major markets.
