Open-label phase 3 study of subcutaneous vedolizumab in pediatric ulcerative colitis or Crohn's disease after response to intravenous vedolizumab

Phase 3, open-label trial of vedolizumab in autoimmune colitis and Crohn's disease (2 arms), sponsored by Takeda. Primary endpoints: Steady-state median observed plasma concentration at the end of a dosing interval for vedolizumab at Week 34 and Average serum concentration at steady state for vedolizumab at Week 34. Planned start Jan 2025; status: authorised.