Teva and Sanofi report Week 44 duvakitug results in ulcerative colitis and Crohn’s disease, with sustained remission and endoscopic outcomes.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
Teva Pharmaceuticals and Sanofi have reported Week 44 maintenance results from the Phase 2b RELIEVE UCCD long-term extension (LTE) study of investigational duvakitug in patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). The findings were presented at United European Gastroenterology (UEG) Week 2026 in Barcelona on October 20.
Duvakitug is an investigational human monoclonal antibody targeting tumour necrosis factor-like ligand 1A (TL1A), a protein involved in inflammatory signalling and potentially associated with intestinal fibrosis in inflammatory bowel disease (IBD). The companies also presented biomarker findings from the induction study examining changes in inflammatory pathways and tissue-remodelling markers.
Week 44 Outcomes in Ulcerative Colitis
The RELIEVE UCCD LTE study included 130 patients who responded to duvakitug during the initial 14-week induction study: 72 with UC and 58 with CD. Patients received subcutaneous duvakitug at 450 mg or 900 mg every four weeks during the maintenance period, which evaluated outcomes through Week 44. Total treatment exposure could extend to 58 weeks.
Among patients with UC, clinical remission measured using the modified Mayo Score (mMS) was reported in 47% of the 450 mg group and 58% of the 900 mg group. Clinical response rates were 82% and 87%, respectively. Endoscopic improvement, defined as a Mayo Endoscopic Score of 0 or 1, occurred in 59% and 63%.
The UC analysis included 34 patients receiving 450 mg and 38 receiving 900 mg. For clinical remission, the reported 95% confidence intervals were 30–65% and 42–73%, respectively.
These results indicate that clinical and endoscopic outcomes were maintained among patients who had responded to induction treatment. Although remission and response rates were numerically higher with 900 mg, the findings were descriptive and do not establish statistically significant superiority of the higher dose.
Outcomes in Crohn’s Disease
In CD, endoscopic response was defined as a reduction of at least 50% from baseline in the Simple Endoscopic Score for Crohn’s Disease (SES-CD). At Week 44, endoscopic response was reported in 41% of patients receiving 450 mg and 55% receiving 900 mg.
Clinical response, measured using the Crohn’s Disease Activity Index (CDAI), occurred in 81% and 87%, respectively. Clinical remission rates were 81% with 450 mg and 84% with 900 mg.
The CD analysis included 27 patients in the 450 mg group and 31 in the 900 mg group. For endoscopic response, the reported 95% confidence intervals were 25–62% and 39–75%, respectively.
The findings suggest continued clinical benefit alongside endoscopic improvement during maintenance treatment. However, the relatively small dose groups and descriptive nature of the analyses limit conclusions about differences between doses. The results also apply specifically to induction responders rather than all patients who begin treatment.
Safety and Tolerability
Duvakitug was generally well tolerated during the maintenance period. The safety profile was consistent with the induction study, and no new safety concerns were identified.
Adverse events reported in at least 5% of patients across pooled dose groups included upper respiratory tract infections and nasopharyngitis in UC. In CD, reported events included upper respiratory tract infections, Crohn’s disease, hypertension, nasopharyngitis, anaemia and influenza. Most adverse events were mild or moderate in severity.
Discontinuations due to adverse events were 4% and 2% in the UC 450 mg and 900 mg groups, respectively, and 6% in each CD dose group. These findings add to the available tolerability data, although the study population is too small to characterise uncommon adverse events reliably.
Biomarker Findings and Clinical Development
Biomarker analyses from the 14-week induction study (NCT05499130) showed reductions in blood markers associated with multiple inflammatory pathways in UC and the Th17 and Th1 immune pathways in CD. Markers of neutrophilic inflammation in blood and tissue were also reduced in both conditions. In patients with CD, treatment was additionally associated with reductions in tissue-remodelling markers.
These findings provide mechanistic evidence supporting further investigation of TL1A inhibition in IBD. However, changes in biomarkers do not demonstrate that duvakitug prevents or reverses intestinal fibrosis, nor do they establish a clinical antifibrotic benefit.
The Phase 3 programme includes SUNSCAPE-1 (NCT07184996) and SUNSCAPE-2 (NCT07185009) in UC, and STARSCAPE-1 (NCT07184931) and STARSCAPE-2 (NCT07184944) in CD. The companies have also initiated the Phase 2 AURALIGHT study (NCT07812116) in moderate-to-severe hidradenitis suppurativa and are planning a Phase 2 study in fibrostenotic Crohn’s disease.
Duvakitug remains investigational, and its safety and efficacy have not been evaluated by any regulatory authority.
Clinical Interpretation
The Week 44 findings support the potential of duvakitug to maintain clinical and endoscopic outcomes in patients with UC or CD who respond to induction treatment. The results provide additional evidence for continued development of TL1A inhibition, particularly given the need for therapies that sustain disease control.
Nevertheless, these data do not establish superiority of the 900 mg dose, and the selected responder population limits generalisation to all patients with IBD. Biomarker changes also remain exploratory evidence rather than proof of fibrosis modification. The ongoing Phase 3 studies will be important in confirming efficacy and further characterising safety.
References
Teva Pharmaceuticals and Sanofi. UEG Week: Teva and Sanofi’s Duvakitug Maintained Long-Term Positive Outcomes in New Phase 2b Data for Ulcerative Colitis and Crohn’s Disease. October 20, 2026.
RELIEVE UCCD long-term extension study: NCT05668013
RELIEVE UCCD induction study: NCT05499130
About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.