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

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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

 ­ Ref: Globe Newswire | Image: Servier

Click here to­ read the full press release 

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