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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT03691974
Collaborator
Teva Pharmaceutical Industries, Ltd. (Industry)
180
Enrollment
47
Locations
2
Arms
26.8
Actual Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Oct 15, 2018
Actual Primary Completion Date :
Jan 30, 2020
Actual Study Completion Date :
Jan 7, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fasinumab

Drug: Fasinumab
Subcutaneous (SC) every four weeks (Q4W)
Other Names:
  • REGN475

    		•
    Placebo Comparator: Placebo

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in peroneal motor nerve conduction velocity [Baseline to week 16]

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

    2. Change in peroneal motor nerve action potential amplitude [Baseline to week 16]

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

    3. Change in sural sensory nerve conduction velocity [Baseline to week 16]

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

    4. Change in sural sensory nerve action potential amplitude [Baseline to week 16]

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

    5. Change in ulnar sensory nerve conduction velocity [Baseline to week 16]

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

    6. Change in ulnar sensory nerve action potential amplitude [Baseline to week 16]

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

    Secondary Outcome Measures

    1. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score [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)

    2. Change in WOMAC physical function subscale score [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)

    3. Incidence of Adjudicated arthropathy (AA) [Week 16]

      As confirmed by an independent adjudication committee

    4. Incidence of Adjudicated arthropathy (AA) [Week 36]

      As confirmed by an independent adjudication committee

    5. Incidence of Destructive arthropathy (DA) [Week 16]

      As confirmed by an independent adjudication committee

    6. Incidence of Destructive arthropathy (DA) [Week 36]

      As confirmed by an independent adjudication committee

    7. Incidence of treatment-emergent adverse event (TEAEs) [Up to 64 weeks]

    8. Incidence of Sympathetic Nervous System (SNS) dysfunction [Up to 36 weeks]

      As diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist

    9. Incidence of peripheral sensory Adverse Events (AEs) that require a neurology consultation [Up to 64 weeks]

    10. Incidence of all-cause joint replacement (JR) surgeries [Week 16]

    11. Incidence of all-cause JR surgeries [Week 36]

    12. Incidence of JRs at telephone survey [52 weeks after last dose of study drug]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regeneron Study Site Glendale Arizona United States 85306
    2 Regeneron Study Site Glendale Arizona United States 85308
    3 Regeneron Study Site Phoenix Arizona United States 85053
    4 Regeneron Study Site Tucson Arizona United States 85412
    5 Regeneron Study Site Anaheim California United States 92805
    6 Regeneron Study Site Clearwater Florida United States 33756
    7 Regeneron Study Site Jacksonville Florida United States 32256
    8 Regeneron Study Site Miami Florida United States 33165
    9 Regeneron Study Site Ocoee Florida United States 34761
    10 Regeneron Study Site Orlando Florida United States 32808
    11 Regeneron Study Site Woodstock Georgia United States 30189
    12 Regeneron Study Site Chicago Illinois United States 60607
    13 Regeneron Study Site Chicago Illinois United States 60611
    14 Regeneron Study Site Caro Michigan United States 48723
    15 Regeneron Study Site Hartsdale New York United States 10530
    16 Regeneron Study Site Cincinnati Ohio United States 45224
    17 Regeneron Study Site Columbus Ohio United States 43235
    18 Regeneron Study Site Bellaire Texas United States 77401
    19 Regeneron Study Site Houston Texas United States 77004
    20 Regeneron Study Site Houston Texas United States 77058
    21 Regeneron Study Site San Antonio Texas United States 72858
    22 Regeneron Study Site Wroclaw Dolnoslaskie Poland 50-381
    23 Regeneron Study Site Lodz Lodzkie Poland 91-211
    24 Regeneron Study Site Warszawa Mazowieckie Poland 01-192
    25 Regeneron Study Site Gdansk Pomorskie Poland 80-382
    26 Regeneron Study Site Gdynia Pomorskie Poland 81-537
    27 Regeneron Study Site Czestochowa Slaskie Poland 42-202
    28 Regeneron Study Site Katowice Slaskie Poland 40-040
    29 Regeneron Study Site Poznan Wielkopolskie Poland 60-702
    30 Regeneron Study Site Lodz Poland 90-127
    31 Regeneron Study Site London Greater London United Kingdom WC1X8QD
    32 Regeneron Study Site Chorley United Kingdom PR7 7NA
    33 Regeneron Study Site Corby United Kingdom NN172UR
    34 Regeneron Study Site Edgbaston United Kingdom B15 2SQ
    35 Regeneron Study Site Glasgow United Kingdom G20 0SP
    36 Regeneron Study Site Hardwick United Kingdom TS19 8PE
    37 Regeneron Study Site Hexham United Kingdom NE46 1QJ
    38 Regeneron Study Site Kenilworth United Kingdom CV81JD
    39 Regulatory Study Site London United Kingdom DA146LT
    40 Regeneron Study Site London United Kingdom RG401XS
    41 Regeneron Study Site London United Kingdom RM13PJ
    42 Regeneron Study Site Manchester United Kingdom M15 6SX
    43 Regeneron Study Site Northwood United Kingdom HA62RN
    44 Regeneron Study Site Peterborough United Kingdom PE73JL
    45 Regeneron Study Site Reading United Kingdom RG2 0TG
    46 Regeneron Study Site Shipley United Kingdom BD183SL
    47 Regeneron Study Site Waterloo United Kingdom L22 0LG

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals
    • Teva Pharmaceutical Industries, Ltd.

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03691974
    Other Study ID Numbers:
    • R475-OA-1758
    • 2017-004921-33
    First Posted:
    Oct 2, 2018
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Osteoarthritis, Hip
    Fasinumab

    Study Results

    No Results Posted as of Dec 8, 2021