Study of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip

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