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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 12, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 8, 2018

Estimated Primary Completion Date

September 27, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in peroneal motor nerve conduction velocity[ Time Frame: Baseline to week 16 ]

An electrophysiological evaluation using standard electrophysiological techniques to measure the speed and extent of nerve conduction

Change in peroneal motor nerve action potential amplitude[ Time Frame: Baseline to week 16 ]

An electrophysiological evaluation using standard electrophysiological techniques to measure the speed and extent of nerve conduction

Change in sural sensory nerve conduction velocity[ Time Frame: Baseline to week 16 ]

An electrophysiological evaluation using standard electrophysiological techniques to measure the speed and extent of nerve conduction

Change in sural sensory nerve action potential amplitude[ Time Frame: Baseline to week 16 ]

An electrophysiological evaluation using standard electrophysiological techniques to measure the speed and extent of nerve conduction

Change in ulnar sensory nerve conduction velocity[ Time Frame: Baseline to week 16 ]

An electrophysiological evaluation using standard electrophysiological techniques to measure the speed and extent of nerve conduction

Change in ulnar sensory nerve action potential amplitude[ Time Frame: Baseline to week 16 ]

An electrophysiological evaluation using standard electrophysiological techniques to measure the speed and extent of nerve conduction

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score[ Time Frame: Baseline to week 16 ]
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
Change in WOMAC physical function subscale score[ Time Frame: Baseline to week 16 ]
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
Incidence of Adjudicated arthropathy (AA)[ Time Frame: Week 16 ]
As confirmed by an independent adjudication committee
Incidence of Adjudicated arthropathy (AA)[ Time Frame: Week 36 ]
As confirmed by an independent adjudication committee
Incidence of Destructive arthropathy (DA)[ Time Frame: Week 16 ]
As confirmed by an independent adjudication committee
Incidence of Destructive arthropathy (DA)[ Time Frame: Week 36 ]
As confirmed by an independent adjudication committee
Incidence of treatment-emergent adverse event (TEAEs)[ Time Frame: Up to 64 weeks ]
Incidence of Sympathetic Nervous System (SNS) dysfunction[ Time Frame: Up to 36 weeks ]
As diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist
Incidence of peripheral sensory Adverse Events (AEs) that require a neurology consultation[ Time Frame: Up to 64 weeks ]
Incidence of all-cause joint replacement (JR) surgeries[ Time Frame: Week 16 ]
Incidence of all-cause JR surgeries[ Time Frame: Week 36 ]
Incidence of JRs at telephone survey[ Time Frame: 52 weeks after last dose of study drug ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee

Brief 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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Fasinumab
Subcutaneous (SC) every four weeks (Q4W)
Other: Placebo
Subcutaneous (SC) every four weeks (Q4W)

Study Arms

Experimental: Fasinumab
Placebo Comparator: Placebo

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

180

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 28, 2020

Estimated Primary Completion Date

September 27, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Regeneron Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Clinical Trial Management Regeneron Pharmaceuticals

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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