Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip

Key Inclusion Criteria:

1. Male or female ≥18 years of age at the screening visit

2. Clinical diagnosis of OA of the knee or hip based on the American College of
Rheumatology criteria with radiologic evidence of OA (K-L score ≥2) for the index
joint at the screening visit

3. Moderate to severe pain in the index joint defined as a WOMAC average pain subscale
score of ≥4

4. A history of 12 weeks of analgesic use for OA of the knee or hip

5. History of regular use of analgesic medications for OA pain

Key Exclusion Criteria:

1. History or presence at the screening visit of non OA inflammatory joint disease

2. History or presence on imaging of arthropathy, stress fracture, recent stress
fracture, neuropathic joint arthropathy, hip dislocation, knee dislocation, congenital
hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence
of bone fragmentation or collapse, or primary metastatic tumor with the exception of
chondromas or pathologic fracture during the screening period

3. Patient is not a candidate for MRI

4. Is scheduled for a joint replacement surgery to be performed during the study period

5. Systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the
screening visit.

6. History or presence at the screening visit of multiple sclerosis, autonomic
neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex
sympathetic dystrophy

7. History or diagnosis of chronic autonomic failure syndrome including pure autonomic
failure, multiple system atrophy

8. Pregnant or breast-feeding women

9. Women of childbearing potential who have a positive pregnancy test result or do not
have their pregnancy test result at baseline

Note: Other protocol defined Inclusion/Exclusion criteria may apply