Sanofi and Teva Report Durable Duvakitug Efficacy at 44 Weeks in UC/CD: RELIEVE UCCD LTE Data

Positive long-term data from the RELIEVE UCCD long-term extension (LTE) study (NCT05668013) highlight duvakitug’s potential as a leading TL1A inhibitor for inflammatory bowel disease (IBD). This investigational human monoclonal antibody maintained clinical and endoscopic efficacy in patients with ulcerative colitis (UC) and Crohn’s disease (CD) who responded to induction therapy, reinforcing its role in addressing unmet needs in IBD treatment.

The RELIEVE UCCD LTE, a double-blind randomized trial, followed 130 responders from the phase 2b induction study (NCT05499130). Patients received subcutaneous duvakitug at 450 mg or 900 mg every four weeks for up to 44 weeks of maintenance (58 weeks total exposure). These results build on the induction phase, where duvakitug outperformed placebo at week 14 for clinically meaningful responses.

 Key Efficacy Highlights at Week 44

• Ulcerative Colitis (UC): 58% (900 mg) and 47% (450 mg) achieved clinical remission per modified Mayo score (mMS), the primary endpoint.
• Crohn’s Disease (CD): 55% (900 mg) and 41% (450 mg) achieved endoscopic response per Simple Endoscopic Score for CD (SES-CD), the primary endpoint.

Benefits extended to secondary endpoints in both cohorts, demonstrating sustained remission and reduced inflammation.

“These results reinforce duvakitug’s potential as a leading TL1A therapy and an important advancement in inflammatory bowel disease treatment with durable efficacy maintained for nearly one year,” said Houman Ashrafian, Executive Vice President, Head of Research and Development, Sanofi.

Duvakitug was well-tolerated, with pooled adverse events (≥5%) including upper respiratory tract infection, nasopharyngitis, Crohn’s disease, and hypertension consistent with induction data. Full results will be presented at an upcoming medical congress.

“These phase 2b results further reinforce TL1A as a compelling target and clearly strengthen the case that duvakitug has the potential to be a best-in-class therapy,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva.

 Understanding IBD and Duvakitug’s Mechanism

IBD affects 4.9 million people globally, with rising incidence. UC and CD cause chronic GI inflammation, leading to symptoms like diarrhea, bleeding, pain, and complications such as fibrosis. No cure exists; treatments aim to induce and sustain remission.

Duvakitug targets TL1A, which drives inflammation and fibrosis via DR3 receptor binding. Now in phase 3 for UC and CD, it offers a novel approach in Sanofi’s IBD pipeline. The RELIEVE UCCD program’s basket design innovatively evaluated both diseases in one trial across the US, Europe, Israel, and Asia.

Detailed findings support expanded indications planned for 2026. Duvakitug’s safety and efficacy await regulatory review.

Reference

Press Release: Sanofi and Teva’s duvakitug phase 2b maintenance data demonstrated clinically meaningful durable efficacy in ulcerative colitis and Crohn’s disease, 17 February 2026, Press Release: Sanofi and Teva’s duvakitug phase 2b maintenance data demonstrated clinically meaningful durable efficacy in ulcerative colitis and Crohn’s disease

 A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s Disease, ClinicalTrials.gov ID NCT05668013, https://clinicaltrials.gov/study/NCT05668013

A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s Disease (RELIEVE UCCD), ClinicalTrials.gov ID NCT05499130, https://clinicaltrials.gov/study/NCT05499130