Duvakitug Phase 2b Maintenance Data Show Durable Remission in UC and Crohn Disease

Teva Pharmaceuticals and Sanofi announced positive long-term extension data from the phase 2b RELIEVE UCCD program showing that duvakitug, an investigational human monoclonal antibody targeting TL1A, maintained clinical and endoscopic efficacy through an additional 44 weeks of maintenance therapy in persons with ulcerative colitis (UC) and Crohn disease (CD) who initially responded during induction.

The RELIEVE UCCD long-term extension (LTE) is a double-blind randomized study evaluating the long-term efficacy, safety, and tolerability of duvakitug in adults with moderate-to-severe UC or CD. Participants who responded after the 14-week induction phase were re-randomized to receive 450 mg or 900 mg subcutaneous duvakitug every 4 weeks during a 44-week maintenance period, for up to 58 weeks of total exposure.

The LTE enrolled 130 responders from the induction study. At week 44 of the maintenance phase, outcomes were as follows:

• Ulcerative colitis: Clinical remission, defined by the modified Mayo score (mMS), was achieved in 58% of patients receiving 900 mg and 47% receiving 450 mg.
• Crohn disease: Endoscopic response, defined by the Simple Endoscopic Score for Crohn’s Disease (SES-CD), was achieved in 55% of patients receiving 900 mg and 41% receiving 450 mg.

According to the companies, consistent benefits were observed across additional efficacy endpoints in both UC and CD cohorts. Detailed data are expected to be presented at a forthcoming medical meeting.

Both dose groups were reported to be well tolerated. The most frequent adverse events occurring in ≥5% of patients receiving pooled duvakitug doses were upper respiratory tract infection, nasopharyngitis, Crohn disease, and hypertension. The safety profile was described as consistent with findings from the phase 2b induction study.

“One of the persistent challenges in treating ulcerative colitis and Crohn’s disease isn’t just achieving an initial response, but sustaining it,” Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva, said in a press release. “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, with the goal of bringing meaningful innovation to patients.”

Houman Ashrafian, Executive Vice President and Head of Research and Development at Sanofi, stated, “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.”

The RELIEVE UCCD program includes a 14-week, randomized, double-blind, placebo-controlled, dose-ranging induction study and the ongoing LTE. The induction study used a basket design enrolling patients with either UC or CD and evaluated efficacy, safety, pharmacokinetics, and tolerability. The primary efficacy endpoints for both induction and maintenance phases were clinical remission (mMS) in UC and endoscopic response (SES-CD) in CD.

Duvakitug is currently being evaluated in phase 3 clinical trials for UC and CD. TL1A signaling is believed to amplify inflammation and contribute to fibrosis in inflammatory bowel disease through binding to its receptor, DR3. Duvakitug preferentially inhibits TL1A-DR3 signaling over binding to decoy receptor 3 (DcR3), with the potential to reduce inflammation and fibrosis.

The safety and efficacy of duvakitug have not been reviewed by any regulatory authority.

Inflammatory bowel disease (IBD), which includes UC and CD, is characterized by chronic gastrointestinal inflammation with relapsing and remitting courses. Globally, approximately 4.9 million cases of IBD have been identified, with incidence rising in several regions. Current treatment strategies aim to induce and maintain remission and prevent disease flares, as no curative therapy is available.

Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug. Sanofi is leading the phase 3 clinical development program.

Reference: Teva and Sanofi’s duvakitug phase 2b maintenance data demonstrated clinically meaningful durable efficacy in ulcerative colitis and Crohn’s disease. News release. Teva Pharmaceuticals. February 17, 2026. Accessed February 17, 2026. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-and-Sanofis-duvakitug-phase-2b-maintenance-data-demonstrated-clinically-meaningful-durable-efficacy-in-ulcerative-colitis-and-Crohns-disease/default.aspx