Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
The primary objective of the study is to evaluate the efficacy of fasinumab compared to
 placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis
 (OA) of the knee or hip.

 The secondary objectives of the study are:

 -  To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs
 (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the
 knee or hip

 -  To assess the safety and tolerability of fasinumab compared to placebo and compared to
 NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee
 or hip
Key Inclusion Criteria (additional criteria may apply at screening):

 1. A clinical diagnosis of osteoarthritis (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.

 2. Willing to discontinue current pain medications and to adhere to study requirements
 for rescue treatments (acetaminophen/paracetamol to be taken as needed with a maximum
 daily dose of 2500 mg [countries where 500 mg strength tablets/capsules are available]
 or 2600 mg [countries where 325 mg strength tablets/capsules are available])

 3. A history of at least 12 weeks of inadequate pain relief or intolerance to analgesics
 used for pain due to OA of the knee or hip

 4. Currently using a stable dose of NSAID

 5. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during
 the 24 weeks of treatment

 Key Exclusion Criteria (additional criteria may apply at screening):

 1. Non-compliance with the numeric rating scale (NRS) recording during the
 pre-randomization period

 2. History or presence at the screening visit of non-OA inflammatory joint disease,
 Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple
 sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal
 osteodystrophy

 3. History or presence on imaging of arthropathy, hip or knee dislocation, extensive
 subchondral cysts, evidence of severe structural damage, bone collapse, or primary
 metastatic tumor with the exception of chondromas or pathologic fractures

 4. Trauma to the index joint within 3 months prior to the screening visit

 5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening

 6. Patient is not a candidate for magnetic resonance imaging (MRI)

 7. Is scheduled for a JR surgery to be performed during the study period or who would be
 unwilling or unable to undergo JR surgery if needed

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

 9. Evidence of autonomic neuropathy as defined in the schedule of assessments (SoAs)

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

 11. Use of systemic corticosteroids within 30 days prior to the screening visit.
 Intra-articular corticosteroids in the index joint within 12 weeks prior to the
 screening visit, or to any other joint within 30 days prior to the screening visit

 12. Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or
 intolerance to anti-NGF antibodies

 13. Women of childbearing potential who are unwilling to practice highly effective
 contraception prior to the start of the first treatment, during the study, and for at
 least 20 weeks after the last dose