Study design of a phase 2 clinical trial with a disease-modifying Osteoarthritis drug candidate GLPG1972/S201086: The roccella trial

Abstract

Purpose: Osteoarthritis (OA) is characterized by structural changes of the joint, of which loss of articular cartilage is one of the major signs. The main proteoglycan component of the extracellular matrix of articular cartilage is aggrecan. ADAMTS-5, A Disintegrin And Metalloproteinase with ThromboSpondin-motif-5, is a key aggrecan-cleaving enzyme involved in cartilage degradation, resulting in ARGS-aggrecan neo-epitope levels measurable in synovial fluid and serum. GLPG1972/S201086 is a highly specific and potent ADAMTS-5 inhibitor in development as an orally administered DMOAD candidate.