Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee.
Status:
Completed
Trial end date:
2018-11-14
Target enrollment:
Participant gender:
Summary
Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth
factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important
breakthrough in the treatment of chronic pain and is under clinical investigation for the
treatment of pain associated with osteoarthritis or other chronic pain conditions.
The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and
2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects
with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy
benefits with a favorable safety profile when administered intravenously in previous Phase 3
clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg
dose based on data from previous studies.