Galapagos and Servier report topline results for ROCCELLA Phase 2 clinical trial with GLPG1972/S201086 in knee osteoarthritis patients

Servier and Galapagos NV report that no signal of activity was observed in the topline results in their ROCCELLA Phase 2 trial with GLPG1972/S201086.

ROCCELLA is a global, double-blind, placebo-controlled, dose ranging trial evaluating the efficacy and safety of three different once-daily oral doses of GLPG1972/S201086 in 932 patients with knee osteoarthritis (OA) over 52 weeks of treatment. The study population was aged between 40 to 76 years (mean age was 63), mainly female (70%) and with a mean disease duration of 7 years.

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 week 52 in cartilage thickness, in mm (SD) was -0.116 (0.27) for the placebo group and -0.068 (0.20), -0.097 (0.27) and -0.085 (0.22), for the low, medium and high dose, respectively. Statistically significant difference versus placebo was not reached in any of the treated groups.

There was no significant difference compared to placebo observed on secondary endpoints, including clinical outcomes.

Additional analyses are being conducted to fully evaluate the results, which will be presented at upcoming medical conferences.

GLPG1972/S201086 was generally well-tolerated by patients in this Phase 2 trial.

ROCCELLA 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. ROCCELLA included 932 patients in 12 countries in Europe, Asia, North and South America. Galapagos was responsible for ROCCELLA in the United States, where 326 patients were recruited. Servier was responsible for this trial in 11 countries, where 606 patients were recruited.