Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee

• Status: Completed
• Trial end date: 2020-12-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Teva Pharmaceutical Industries, Ltd.
• Treatments: Fasinumab

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