Duvakitug Shows Durable 44-Week Efficacy in UC and Crohn's Disease

On February 17, 2026, Sanofi and Teva announced positive results from the RELIEVE UCCD long-term extension (LTE) study of duvakitug, an investigational human monoclonal antibody targeting TL1A, showing durable clinical and endoscopic efficacy maintained over 44 weeks in patients with ulcerative colitis (UC) and Crohn’s disease (CD) who initially responded to the induction phase. RELIEVE UCCD LTE is a double-blind randomized study evaluating the long-term efficacy, safety, and tolerability of duvakitug in UC and CD, the two most common forms of inflammatory bowel disease (IBD).

These longer duration data reinforce the efficacy from the RELIEVE UCCD phase 2b induction study (NCT05499130), which demonstrated that patients achieved clinically meaningful response with duvakitug compared to placebo at week 14. The LTE study enrolled 130 patients who responded to duvakitug in the induction study and entered a 44-week maintenance period. Patients were re-randomized to receive either a 450 mg or 900 mg subcutaneous dose of duvakitug every four weeks for up to a total of 58 weeks of exposure.

At week 44 of the maintenance period, both doses of duvakitug were well tolerated. The most frequent observed adverse events (≥5% of all patients) with pooled duvakitug doses were upper respiratory tract infection, nasopharyngitis, Crohn’s disease, and hypertension, consistent with the RELIEVE UCCD phase 2b induction study. Detailed results will be presented at a forthcoming medical meeting.

“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 in patients living with ulcerative colitis or Crohn's disease,” said the Executive Vice President, Head of Research and Development at Sanofi. “With phase 3 studies underway, we're committed to advancing duvakitug for patients who need new options, and it remains a key opportunity in our pipeline.”

The Executive Vice President, Global R&D and Chief Medical Officer at Teva added: “One of the persistent challenges in treating ulcerative colitis and Crohn’s disease isn’t just achieving an initial response, but sustaining it. 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. They also provide further evidence to support additional indications we anticipate announcing this year.”

IBD is an autoimmune disorder characterized by chronic inflammation of the gastrointestinal tract. Globally, approximately 4.9 million cases of IBD have been identified, with incidence rising in several regions. The two main types of IBD are UC and CD, which are characterized by repetitive cycles of relapses and remission. Common symptoms of both conditions include persistent diarrhea, rectal bleeding, abdominal pain, loss of appetite, and weight loss. Currently, there is no cure for IBD; the goal of current treatment is to induce and maintain remission and prevent flares.

The RELIEVE UCCD program is comprised of an induction study and a long-term extension. RELIEVE UCCD was a 14-week phase 2b, randomized, double-blinded, dose-ranging induction study to evaluate the efficacy, safety, pharmacokinetics, and tolerability of duvakitug in adults with moderate-to-severe UC or CD. It used an innovative basket study design allowing the inclusion of patients with either UC or CD, and it is the first and only randomized, blinded and placebo-controlled phase 2 study to investigate the impact of TL1A in CD. Primary efficacy endpoints for both the 14-week induction study and the 44-week maintenance period are clinical remission (as defined by mMS) in the UC cohort or endoscopic response (as defined by SES-CD) in the CD cohort. The study includes sites in the US, Europe, Israel, and Asia.