Darvadstrocel in Patients With Crohn's Disease With Complex Perianal Fistulas: The ADMIRE CD II Phase 3 Randomized Trial - PubMed
4 days ago
- #Crohn's Disease
- #Clinical Trial
- #Darvadstrocel
- The ADMIRE CD II trial investigated the efficacy and safety of darvadstrocel in patients with Crohn's disease and complex perianal fistulas.
- This was a phase 3, double-blind, randomized, placebo-controlled trial conducted in Europe, Israel, and North America.
- Patients received either darvadstrocel (120 × 10^6 stem cells) or placebo, with both groups undergoing curettage and closure of the internal opening.
- The primary endpoint was combined remission (closure of all treated external openings and absence of collections >2 cm) at week 24.
- At week 24, combined remission was achieved in 48.8% of darvadstrocel patients and 46.3% of placebo patients, with no statistically significant difference (P = .571).
- No significant differences were observed in key secondary endpoints, including clinical remission at week 24 and time to clinical remission.
- Treatment-emergent adverse events were similar between darvadstrocel (73.0%) and placebo (73.4%) groups.
- The trial did not meet its primary endpoint, and no new safety signals were identified for darvadstrocel.