Osteoarthritis, Hip, Osteoarthritis, Knee
Conditions
Brief summary
The primary objective of this study is to evaluate the effectiveness of REGN475 compared to placebo in participants with pain due to osteoarthritis (OA) of the knee or hip and a history of inadequate joint pain relief or intolerance to current analgesic therapy.
Interventions
DRUGREGN475
DRUGPlacebo
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Body mass index ≤39 2. Clinical diagnosis of OA of the knee or hip 3. History of inadequate pain relief or intolerance to analgesics used for OA 4. Moderate to severe pain in the index joint 5. History of regular use of analgesic medications for OA pain 6. Willing to discontinue current non-steroidal anti-inflammatory drug (NSAID) and opioid pain medications Key
Exclusion criteria
1. Other diseases that may involve index knee or hip, including inflammatory joint diseases, crystalline disease (gout or pseudogout), endocrinopathies, metabolic joint disease, lupus erythematosus, rheumatoid arthritis, joint infections, neuropathic disorders, avascular necrosis, Paget's disease, renal osteodystrophy or tumors 2. History of osteonecrosis, destructive arthropathy (RPOA), hip dislocation, pathologic fractures, neuropathic joint arthropathy, knee dislocation or hip dislocation 3. Trauma to the index joint in the 30 days before screening 4. Active fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA 5. Prior to the start of the study has received a recommendation for, or is scheduled for joint replacement surgery to be performed during the study period 6. Presence of subchondral insufficiency fracture on screening films or MRI 7. Received an intra-articular injection of hyaluronic acid in the affected index joint within 90 days prior to the screening visit 8. Systemic (ie, oral or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks of the screening visit, or to any other joint within 30 days prior to the screening visit. 9. History of autonomic neuropathy, diabetic neuropathy, or presence of clinically relevant peripheral neuropathy at the time of screening 10. Women of childbearing potential who have a positive pregnancy test result, or who do not have their pregnancy test results at baseline 11. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint in the study is the change from baseline to week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score. | Baseline to week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 16 in the WOMAC physical function subscale score | Baseline to week 16 |
| Change from baseline to week 16 in the Patient Global Assessment score | Baseline to week 16 |
| Incidence of treatment-emergent adverse events (TEAEs) | Baseline to week 36 (end of study) |
| Incidence of anti-REGN475 antibody development | Baseline to week 36 (end of study) |
Countries
United States
Outcome results
None listed