Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis

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  • The P-II ROCCELLA is a dose-ranging trial involves assessing GLPG1972/S201086 (PO, qd) in three different doses vs PBO in 932 patients with knee OA for 52wks. across 12 countries including EU, Asia, North and South America. Galapagos is responsible for ROCCELLA in the US, where 326 patients were recruited while Servier will be solely responsible for trial in 11 countries where 606 patients were recruited
  • The trial failed to meet its 1EPs as the change from baseline to 52 in cartilage thickness in mm (SD) is {-0.068 (0.20), -0.097 (0.27) & -0.085 (0.22)} vs -0.116 (0.27) for the low, medium & high dose respectively
  • No difference in 2EPS including clinical outcomes, the therapy was generally well-tolerated by patients in the P-II study

Click here ­to­ read full press release/ article | Ref: Globe Newswire | Image: Servier

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