By: IPP Bureau
Last updated : February 17, 2026 8:29 pm
Duvakitug was well tolerated and safety was consistent with the induction study
Teva Pharmaceuticals and Sanofi have reported positive 44-week data from the RELIEVE UCCD long-term extension study of duvakitug. The investigational TL1A-targeted antibody demonstrated durable clinical and endoscopic efficacy in patients with ulcerative colitis and Crohn’s disease. This double-blind study confirms that duvakitug maintains long-term safety and effectiveness for patients who initially responded to induction therapy.
These longer duration data reinforce the efficacy from the RELIEVE UCCD phase 2b induction study, which demonstrated that patients achieved clinically meaningful response with duvakitug compared to placebo at week 14.
“One of the persistent challenges in treating ulcerative colitis and Crohn’s disease isn’t just achieving an initial response, but sustaining it,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “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.”
The study enrolled 130 patients who responded to duvakitug in the RELIEVE UCCD 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:
UC: 58% (900 mg) and 47% (450 mg) of patients treated with duvakitug achieved the primary endpoint of clinical remission per the modified Mayo score (mMS).
CD: 55% (900 mg) and 41% (450 mg) of patients treated with duvakitug achieved the primary endpoint of endoscopic response as defined by the Simple Endoscopic Score for CD (SES-CD).
In both UC and CD, consistent benefits were observed across additional efficacy endpoints.
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 and were consistent with the RELIEVE UCCD phase 2b induction study. Detailed results from the study 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 Houman Ashrafian, Executive Vice President, Head of Research and Development, 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.”