Sanofi's Duvakitug Achieves 58% UC Remission, 55% CD Response in 44-Week Trial
Sanofi and Teva’s RELIEVE UCCD trial tested 450 mg and 900 mg duvakitug in 130 ulcerative colitis and Crohn’s patients over 44 weeks. The 900 mg dose achieved 58% UC remission and 55% CD response versus 47% and 41% at 450 mg, with both doses well tolerated.
1. Trial Design and Patient Population
The RELIEVE UCCD long-term extension study enrolled 130 patients with ulcerative colitis or Crohn’s disease who responded to initial induction therapy. Participants were randomized to receive either 450 mg or 900 mg subcutaneous duvakitug every four weeks, with efficacy assessed through 44 weeks of treatment.
2. Efficacy Outcomes
At week 44, 58% of ulcerative colitis patients receiving 900 mg achieved clinical remission compared to 47% at 450 mg. In Crohn’s disease, endoscopic response rates were 55% for the 900 mg cohort versus 41% for the 450 mg group, demonstrating dose-dependent efficacy.
3. Safety and Tolerability
Both dose groups showed a safety profile consistent with earlier phases, with no new adverse events reported. Injection-site reactions and infections were comparable between the 450 mg and 900 mg arms, confirming duvakitug’s tolerability over the 44-week period.
4. Next Steps in Development
Following these positive Phase IIb results, Sanofi and Teva plan to advance duvakitug into pivotal Phase III trials. Milestones include patient enrollment criteria finalization and regulatory submissions scheduled later this year.