The design of a randomized, placebo-controlled, dose-ranging trial to investigate the efficacy and safety of the ADAMTS-5 inhibitor S201086/GLPG1972 in knee osteoarthritis.

ABSTRACT:

Objective

This study aims to assess the efficacy of the anticatabolic 'a disintegrin and metalloproteinase with thrombospondin motif-5' (ADAMTS-5) inhibitor, S201086/GLPG1972, in slowing cartilage loss in participants with knee osteoarthritis (OA).

Design

ROCCELLA (NCT03595618) is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging, phase 2 trial. We plan to enrol a total of 852 participants with knee OA across 12 countries. Participants will be randomized 1:1:1:1 to receive 75, 150 or 300 ​mg S201086/GLPG1972, or placebo orally, once daily for 52 weeks. Eligible participants will be aged 40-75 years and have predominantly medial knee OA with centrally read Kellgren-Lawrence grade 2 or 3, OARSI atlas medial femorotibial joint space narrowing grade 1

SUBMITTER: Imbert O 

PROVIDER: S-EPMC9718074 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature