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Galapagos Knee OA Study


Title Efficacy and safety of 3 doses of S201086/GLPG1972 administered orally once daily in patients with knee osteoarthritis. A 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled, dose-ranging study (ROCCELLA Study) 
Therapeutic Area Osteoarthritis
Principal Investigator Steven C. Vlad, MD, PhD
Min Age 40 Years
Max Age 75 Years
Gender All
Contact Vivian Deng
617-636-5727
More Information https://www.clinicaltrials.gov/ct2/show/NCT03595618

Overview

The main purpose of this study is to evaluate safety and efficacy of three doses of the study drug, GLPG1972 compared to placebo. The study drug will be administered as an oral pill daily. This drug aims to reduce the cartilate breakdown in patients with knee osteoarthritis (OA). GLPG1972 is being tested and is not approved for use for patients with knee OA by the United States Food and Drug Administration (FDA). 

Study Details

Inclusion Criteria

  • Subject must have knee pain for at least 6 months
  • Subject must have tried systemic non-steroid anti-inflammatory drugs (NSAIDS) and/or other analgesics for knee pain
  • Subject must be willing to undergo knee MRI exam

Exclusion Criteria

  • Subject who has inflammatory diseases
  • Subject who has hypersensitivity to lactose

Study Requirements

This study will take approximately 61 weeks to complete and will require at least 10 visits to Tufts Medical Center. Each visit will take approximately 1 to 3 hours. At these visits, physical examination, electrocardiogram (ECG), vital signs will be performed. Your blood and urine samples will be collected to check your health at each visit. There will be two X-rays of your knees and 3 MRI scans of your knee throughout the study.