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

Regeneron Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Osteoarthritis, Hip

Osteoarthritis, Knee

Treatments

Other: Placebo

Drug: Fasinumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03691974

R475-OA-1758

2017-004921-33 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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
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
Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments
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
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:

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
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
Trauma to the index joint within 3 months prior to the screening visit
History or presence of signs or symptoms of compression neuropathy, including carpal tunnel syndrome or sciatica
Participant is not a candidate for Magnetic Resonance Imaging (MRI)
Poorly controlled diabetes
Known history of human immunodeficiency virus (HIV) infection
Known history of ocular herpes simplex virus, herpes simplex virus pneumonia, or herpes simplex virus encephalitis
History of poorly controlled hypertension
Known history of infection with hepatitis B or C virus

Note: Other protocol defined Inclusion/Exclusion apply