Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee
Condition: Osteoarthritis, Knee; Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Intervention: Fasinumab; Placebo
Intervention description: Subcutaneous (SC) every four weeks (Q4W); Subcutaneous (SC) every four weeks (Q4W)
Intervention MeSH terms: Fasinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to evaluate the effect of fasinumab compared to placebo
      on peripheral nerves in participants with pain due to Osteoarthritis (OA) of the hip or knee.

      The secondary objectives of the study are to:

        -  Evaluate the efficacy of fasinumab compared to placebo in participants with pain due to
           OA of the hip or knee

        -  Evaluate the safety and tolerability of fasinumab compared to placebo in participants
           with pain due to OA of the hip or knee

        -  Characterize the concentrations of fasinumab in serum in participants with pain due to
           OA of the hip or knee

        -  Evaluate the immunogenicity of fasinumab in participants with pain due to OA of the hip
           or knee.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. A 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

          2. Moderate-to-severe pain in the index joint defined as a WOMAC average pain subscale
             score of ≥4 at both the screening and randomization visits

          3. Willing to discontinue current pain medications and to adhere to study requirements
             for rescue treatments

          4. A history of regular use of analgesic medications for OA pain (defined as an average
             of 4 days per week over the 4 weeks prior to the screening visit), including oral
             nonsteroidal anti-inflammatory drugs (NSAIDs), selective cyclooxygenase 2 inhibitors,
             opioids, paracetamol/acetaminophen, or combinations thereof

          5. Consent to allow all radiographs and medical/surgical/hospitalization records of care
             received elsewhere prior to and during the study period to be shared with the
             investigator

        Key Exclusion Criteria:

          1. History or presence at the screening visit of non-OA inflammatory joint disease (eg,
             rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudo-gout, gout,
             spondyloarthropathy, polymyalgia rheumatica, joint infections within the past 5
             years), Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple
             sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal
             osteodystrophy

          2. History or presence on imaging of arthropathy (osteonecrosis, subchondral
             insufficiency fracture, rapidly progressive OA type 1 or type 2), stress fracture,
             recent stress fracture, neuropathic joint arthropathy, hip dislocation (prosthetic hip
             dislocation is eligible), knee dislocation (patella dislocation is eligible),
             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 fractures during the screening period

          3. Trauma to the index joint within 3 months prior to the screening visit

          4. History or presence of signs or symptoms of compression neuropathy, including carpal
             tunnel syndrome or sciatica

          5. Participant is not a candidate for Magnetic Resonance Imaging (MRI)

          6. Poorly controlled diabetes

          7. Known history of human immunodeficiency virus (HIV) infection

          8. Known history of ocular herpes simplex virus, herpes simplex virus pneumonia, or
             herpes simplex virus encephalitis

          9. History of poorly controlled hypertension

         10. Known history of infection with hepatitis B or C virus

        Note: Other protocol defined Inclusion/Exclusion apply