Servier and Galapagos announce start of global ROCCELLA Phase 2 clinical trial with S201086/GLPG1972 in osteoarthritis patients
26 June 2018 at 22:01 CET
Paris (France) and Mechelen (Belgium), 26 June 2018, 22.01 CET - Servier, an independent international pharmaceutical company, and Galapagos NV (Euronext & NASDAQ: GLPG) announce the start of a global Phase 2 trial with S201086/GLPG1972 in knee osteoarthritis patients: ROCCELLA. Galapagos will be eligible to receive a €9 million milestone payment upon first dosing of a patient in ROCCELLA.
Servier and Galapagos have submitted and will further submit clinical trial applications in a number of countries in North and South America, Europe and Asia. The study will now be initiated in the US and Hungary with other countries expected to follow, pending the respective regulatory approvals. ROCCELLA will be a multiregional, randomized, double-blind, placebo-controlled, dose ranging trial evaluating the efficacy and safety of three different once-daily doses of S201086/GLPG1972 in patients with knee osteoarthritis (OA). ROCCELLA is planned to recruit approximately 850 patients in up to 15 countries. Galapagos will be responsible for ROCCELLA in the United States, where 300 patients are targeted to be recruited. Servier will run the trial in all other countries.