Galapagos and Servier Report ROCELLA Trial of GLPG1972/S201086 Failed to Meet Primary Endpoint in Osteoarthritis Knee Repair

Galapagos and Servier Report ROCELLA Trial of GLPG1972S201086 Failed to Meet Primary Endpoint in Osteoarthritis Knee Repair

Gapapagos and Servier reported topline results from the phase 2 ROCELLA trial, which evaluated GLPG1972/S201086 versus placebo in treating patients with knee osteoarthritis. The trial failed to show efficacy over placebo. Additional analyses are being conducted to fully evaluate the results, which will be presented at upcoming medical conferences.

ROCELLA was a multi-regional, randomized, double-blind, placebo-controlled, dose ranging trial evaluating the efficacy and safety of three different once-daily oral doses of GLPG1972/S201086 in patients with knee osteoarthritis. The trial enrolled 932 patients in 12 countries in Europe, Asia, North and South America. Galapagos was responsible in the United States, where 326 patients were recruited. Servier was responsible for this trial in 11 countries, where 606 patients were recruited.

The primary objective of ROCCELLA was to demonstrate the efficacy of at least one dose of GLPG1972/S201086 compared to placebo after 52 weeks of treatment in reducing cartilage loss of the central medial tibiofemoral compartment of the target knee via quantitative MRI.

The trial failed to meet the primary objective. The change from baseline to w...

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