A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip (FACT OA1)

October 18, 2022 updated by: Regeneron Pharmaceuticals

A Phase 3 Randomized, Double-blind, Multi-dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip

The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip.

The secondary objectives of the study are:

  1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip
  2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
  3. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip
  4. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip
  5. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip
  6. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks
  7. To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks
  8. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks
  9. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks
  10. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip

Study Overview

Study Type

Interventional

Enrollment (Actual)

3307

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vejle, Denmark, DK 7100
        • CCBR Vejle
      • Berlin, Germany, 12627
        • Synexus Clinical Research GmbH
      • Bochum, Germany, 44787
        • Synexus Clinical Research GmbH
      • Frankfurt, Germany, 60313
        • Synexus Clinical Research GmbH
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Synexus Clinical Research GmbH
      • Budapest, Hungary, 1036
        • Qualiclinic Kft.
      • Budapest, Hungary, 1036
        • Synexus Magyarország Kft
      • Debrecen, Hungary, 4025
        • Synexus Magyarorszag Kft.
      • Gyula, Hungary, 5700
        • Synexus Magyarorszag Kft.
      • Hatvan, Hungary, 3000
        • BKS Research Kft.
      • Hévíz, Hungary, 8380
        • Hevizgyogyfurdo es Szent Andraes ReumaKorhaz
      • Nyíregyháza, Hungary, 4400
        • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak Josa Andras Oktatokorhaza Klinikai Kutatasi Osztaly
      • Zalaegerszeg, Hungary, 8900
        • Synexus Magyarorszag Egeszsegugyi Kft.
      • Kaunas, Lithuania, LT35144
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
      • Kaunas, Lithuania, LT50009
        • Saules Seimos Medicinos Centras, JSC
      • Panevėžys, Lithuania, LT01117
        • Republican Panevezys Hospital
      • Vilnius, Lithuania, LT01117
        • Center Outpation Clinic, Public Institution
      • Białystok, Poland, 15-879
        • ClinicMed Daniluk, Nowak Sp.J.
      • Katowice, Poland, 40-040
        • Synexus Polska Sp. Z O.O. Oddzial W Katowicach
      • Kraków, Poland, 30-149
        • Malopolskie Centrum Kliniczne
      • Skierniewice, Poland, 96-100
        • CLINMEDICA RESEARCH OMC, Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa
      • Zgierz, Poland, 95-100
        • ETG Zgierz
    • Dolnoslaskie
      • Wrocław, Dolnoslaskie, Poland, 59-381
        • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
    • Lodzkie
      • Łódź, Lodzkie, Poland, 90-368
        • Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o. Jednostka 02 - SOMED - Lodzkie Centrum Osteoporozy
    • Malopolskie
      • Kraków, Malopolskie, Poland, 31-501
        • Krakowskie Centrum Medyczne Sp. z o.o.
    • Mazowieckie
      • Grodzisk Mazowiecki, Mazowieckie, Poland, 05-825
        • MCBK Sc lwona Czajkowska Monika Barney
      • Warszawa, Mazowieckie, Poland, 01-192
        • Synexus Polska Sp. z o.o. Oddzial w Warszawie
      • Warszawa, Mazowieckie, Poland, 04-730
        • Specjalistyczny Osrodek Medycyny Wieku Dojrzalego sp. z o.o.
    • Pomorskie
      • Gdynia, Pomorskie, Poland, 81-537
        • Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Gdynia, Pomorskie, Poland, 81-537
        • Synexus Polska Sp. z o.o. Oddzial w Gdyni
    • Wielkopolskie
      • Poznań, Wielkopolskie, Poland, 60-702
        • Synexus Polska Sp. z o.o Oddzial w Poznaniu
      • Bucharest, Romania, 021611
        • Clinica Medicala Synexus Ltd.
      • Bucharest, Romania, 030463
        • SC Policlinica CCBR SRL
      • Novosibirsk, Russian Federation, 630099
        • "CDCR ""Healthy Joints"" L.L.C."
      • Saint Petersburg, Russian Federation, 192263
        • City Out-Patient Clinic #109
      • Samara, Russian Federation, 443095
        • Samara Regional Clinical Hospital n.a.V.D.Seredavin
      • Yaroslavl, Russian Federation, 150007
        • "State Autonomous Healthcare Institution of Yaroslavl Oblast ""Clinical Hospital #3"""
    • Tatarstan Republic
      • Kazan, Tatarstan Republic, Russian Federation, 420012
        • "SBEIHPE ""Kazan State Medical University"" of MHSD of Russia"
      • Cape Town, South Africa, 7530
        • TASK Applied Science
      • Cape Town, South Africa, 7764
        • Mzansi Ethical Research Centre Cape Town
      • Johannesburg, South Africa, 2113
        • Newtown Clinical Research
    • Cape Town
      • Parow, Cape Town, South Africa, 7500
        • Tread Research-Tygerberg Hospital
    • Free State
      • Welkom, Free State, South Africa, 9460
        • Welkom Clinical Trial Centre
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2013
        • WITS Clinical Research
      • Pretoria, Gauteng, South Africa, 0002
        • University of Pretoria
      • Pretoria, Gauteng, South Africa, 0083
        • Global Clinical Trials
      • Pretoria, Gauteng, South Africa, 0122
        • Synexus SA Stanza Clinical Research Centre
      • Pretoria, Gauteng, South Africa, 0184
        • Synexus Watermeyer Clinical Research Centre
      • Roodepoort, Gauteng, South Africa, 1724
        • Roodepoort Medicross Clinical Research Centre
    • Johannesburg
      • Soweto, Johannesburg, South Africa, 1818
        • Soweto Clinical Trials Centre (CTC)
    • Kwa-Zulu Natal
      • Durban, Kwa-Zulu Natal, South Africa, 4001
        • Synapta Clinical Research Center
      • Umkomaas, Kwa-Zulu Natal, South Africa, 4170
        • Aliwal Shoal Medical Centre
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Enhancing Care
    • Mpumalanga
      • Middelburg, Mpumalanga, South Africa, 1055
        • Mzansi Ethical Research Centre Middleburg
    • Western Cape
      • Kraaifontein, Western Cape, South Africa, 7570
        • Langeberg Medicross Medical Centre
      • Paarl, Western Cape, South Africa, 7646
        • Paarl Research Centre
      • Somerset West, Western Cape, South Africa, 7130
        • Synexus Helderberg Clinical Trial Centre
      • A Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruna
      • Madrid, Spain, 28100
        • MeDiNova Investigacion y Desarrollo
      • Santiago De Compostela, Spain, 15705
        • Centro De Investigacion Clinica En Enfermedades Cronicas - Cicec
      • Sevilla, Spain, 41003
        • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
      • Sevilla, Spain, 41010
        • Hospital Quiron Salud Infanta Luisa
    • Madrid
      • Leganés, Madrid, Spain, 28915
        • CETA Leganes
      • Cherkasy, Ukraine, 18009
        • "Municipal Establishment ""Cherkasy Regional Hospital of Cherkasy Oblast Council"""
      • Kharkiv, Ukraine, 61029
        • Kharkiv City Multispecialty Hospital #18
      • Kyiv, Ukraine, 02002
        • Medical center of Private High Educational Institute Institute of General Practice-Family Medicine
      • Kyiv, Ukraine, 03037
        • "Subsidiary Company ""Medical Research and Practice Center Medbud of the Public Joint Stock ""Holding Company ""Kyivmiskbud"""
      • Kyiv, Ukraine, 03049
        • "Kyiv Railway Clinical Hospital No.2 of branch ""Health Center "" of the PJSC ""Ukrainian Railway"""
      • Lviv, Ukraine, 79495
        • Lviv Regional Hospital for veterans of the war and former political prisoners
      • Cardiff, United Kingdom, CF15 9SS
        • Synexus Wales Clinical Research Centre
      • Liverpool, United Kingdom, L22 0LG
        • Synexus Merseyside Clinical Research Centre
      • Manchester, United Kingdom, M15 6SX
        • Synexus Manchester Clinical Research Centre-Manchester Science Park
      • Romford, United Kingdom, RM1 3PJ
        • MediNova Research East London Clinical Studies Centre
      • Shipley, United Kingdom, BD18 3SA
        • MeDiNova Research Yorkshire Clinical Studies Centre
      • Sidcup, United Kingdom, DA14 6LT
        • Medinova South London Dedicated Research Centre
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG2 0TG
        • Synexus Thames Valley Clinical Research Centre
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G20 0SP
        • Synexus Scotland Clinical Research Centre
    • Lancashire
      • Chorley, Lancashire, United Kingdom, PR7 7NA
        • Synexus Lancashire Clinical Research Centre
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • MediNova North London Dedicated Research Centre, Mount Vernon Hospital
    • Northumberland
      • Hexham, Northumberland, United Kingdom, NE46 1QJ
        • Synexus North East Clinical Research Centre - Hexham General Hospital
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2SQ
        • Synexus Midlands Clinical Research Centre
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Phoenix, Arizona, United States, 85053
        • Arizona Research Center
      • Tucson, Arizona, United States, 85712
        • Tucson Orthopaedic Research Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Baptist Health Center for Clinical Research
    • California
      • Covina, California, United States, 91722
        • Medvin Clinical Research
      • El Cajon, California, United States, 92020
        • TriWest Research Associates, LLC
      • La Mesa, California, United States, 91942
        • BioSolutions Clinical Research
      • Los Angeles, California, United States, 90045
        • Pacific Arthritis Care Center
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
      • San Marcos, California, United States, 92078
        • Artemis Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Lynn Institute of Denver
      • Colorado Springs, Colorado, United States, 80920
        • Lynn Institute of The Rockies
      • Golden, Colorado, United States, 80401
        • Panorama Orthopedics & Spine Center
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis and Rheumatic Disease Specialties
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc.
      • Ocoee, Florida, United States, 34761
        • Sensible Healthcare
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
      • Orlando, Florida, United States, 32825
        • Jewett Orthopaedic Clinic
      • Venice, Florida, United States, 34292
        • Lovelace Scientific Resources
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60602
        • Medex Healthcare Research, Inc.
      • Flossmoor, Illinois, United States, 60422
        • Healthcare Research Network II, LLC
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Integrated Clinical Trial Services, Inc.
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Klein & Associates, MD PA
      • Hagerstown, Maryland, United States, 21740
        • Klein & Associates, MD, PA
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology and Bone Research
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Clinical Pharmacology Study Group
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • The Center for Pharmaceutical Research
      • Saint Louis, Missouri, United States, 63117
        • Medex Healthcare Research, Inc.
      • Saint Louis, Missouri, United States, 63141
        • Sundance Clinical Research, LLC
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Physician Research Collaboration, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Lovelace Scientific Resources, Inc.
    • New York
      • Binghamton, New York, United States, 13901
        • United Medical Associates
      • Endwell, New York, United States, 13760
        • Regional Clinical Research, Inc.
      • New York, New York, United States, 10036
        • Medex Healthcare Research
      • Orchard Park, New York, United States, 14127
        • Orchard Park Family Practice
      • Orchard Park, New York, United States, 14127
        • Buffalo Rheumatology and Medicine, PLLC
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
      • Charlotte, North Carolina, United States, 28210
        • DJL Clinical Research, PLLC
      • Hickory, North Carolina, United States, 28601
        • Hickory Family Practice Associates
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research LLC
      • Salisbury, North Carolina, United States, 28144
        • PMG Research of Salisbury, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Sterling Research Group, Ltd.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73119
        • Hillcrest Clinical Research
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Low Country Rheumatology, PA
      • Mount Pleasant, South Carolina, United States, 29464
        • PMG Research of Charleston, LLC
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Clinical Research Solutions
      • Knoxville, Tennessee, United States, 37912
        • PMG Research of Knoxville
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
    • Texas
      • Cypress, Texas, United States, 77429
        • Pioneer Research Solutions, Inc.
      • Mesquite, Texas, United States, 75150
        • SouthWest Rheumatology Research, LLC
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Center for Arthritis and Rheumatic Diseases
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Rheumatology & Pulmonary Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria include, but are not limited to, the following:

Year 1:

  1. Male and female patients, at least 18 years of age, at screening
  2. 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
  3. Moderate to severe pain in the index joint defined at both the screening and randomization visits
  4. Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments (acetaminophen/paracetamol) to be taken as needed with a maximum daily dose of 2500 mg (countries where 500 mg strength tablets/capsules are available) or 2600 mg (countries where 325 mg strength tablets/capsules are available)
  5. A history of at least 12 weeks of analgesics use for pain due to OA of the knee or hip, as defined by:

    1. Inadequate pain relief from acetaminophen/paracetamol AND
    2. Intolerance to or inadequate pain relief from opioid or tramadol therapy, unwillingness to take opioid or tramadol therapy for a medically acceptable reason, or lack of access to an opioid or to tramadol
  6. Currently using a stable dose of NSAID.
  7. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the initial 16 weeks of treatment
  8. Stable treatment with glucosamine sulfate and chondroitin sulfate treatments must be stopped during the pre-randomization period
  9. 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
  10. Willing to maintain current activity and exercise levels throughout the study
  11. Willing and able to comply with clinic visits and study-related procedures and willing to provide follow-up information related to any JR surgery that occurs within the period of time covered by their intended participation in the study
  12. Able to understand and complete study-related questionnaires

Year 2:

Note: Any Year 1 patient attending their week 52 visit on or after 26 March 2020 will no longer have the option to enroll into Year 2.

  1. Completed the treatment period of Year 1
  2. Did not permanently discontinue study drug during Year 1
  3. Received no less than 10 of the 13 planned doses of SC study drug during the treatment period of Year 1
  4. Provide informed consent for Year 2
  5. Willing to continue to maintain current activity and exercise levels throughout Year 2

Exclusion Criteria include, but are not limited to, the following:

  1. Non-compliance with the Numeric Rating Scale (NRS) recording during the pre-randomization period
  2. History or presence at the screening visit of non-OA inflammatory joint disease, Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
  3. History or presence on imaging of arthropathy, neuropathic joint arthropathy, hip or knee dislocation, extensive subchondral cysts, significant bone collapse or bone loss, or pathologic fractures
  4. Trauma to the index joint within 3 months prior to the screening visit
  5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
  6. Patient is not a candidate for MRI
  7. Is scheduled for a JR surgery to be performed during the study period or who would be unwilling or unable to undergo JR surgery if needed
  8. History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
  9. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
  10. History of naproxen intolerance, or existence of a medical condition that is high risk for naproxen-associated complications
  11. Resting heart rate of <50 beats per minute (bpm) or >100 bpm at the screening or randomization visits
  12. History or presence of 2nd or 3rd degree heart block, 1st degree heart block with abnormal Complex of Q, R, and S waves on an electrocardiogram (QRS) complex, or bifascicular block by ECG assessment at the screening visit
  13. History or presence of orthostatic hypotension at the screening, prerandomization, or randomization visits
  14. History of poorly controlled hypertension
  15. Use of systemic corticosteroid within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit
  16. Exposure to an anti-Nerve growth factor (NGF) antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fasinumab dosing regimen 1
Fasinumab Subcutaneous (SC) dosing regimen 1 and naproxen-matching placebo oral
Solution for injection in pre-filled syringe
Other Names:
  • REGN475
Capsule
Experimental: Fasinumab dosing regimen 2
Fasinumab SC dosing regimen 2 and naproxen-matching placebo oral
Solution for injection in pre-filled syringe
Other Names:
  • REGN475
Capsule
Experimental: Fasinumab-matching placebo and naproxen
Pharmaceutical form: Capsule
Solution for injection in pre-filled syringe
Experimental: Fasinumab-matching placebo and naproxen-matching placebo
Capsule
Solution for injection in pre-filled syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to Week 16
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Baseline to Week 16
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen
Time Frame: Baseline to Week 16
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Baseline to Week 16
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo
Time Frame: Baseline to Week 44
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Baseline to Week 44
Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
Time Frame: Baseline to Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
Time Frame: Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Week 16
Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
Time Frame: Baseline to Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo
Time Frame: Baseline to Week 44
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 44
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen
Time Frame: Baseline to Week 44
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 44
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to average score across weeks 4, 8, 12 and 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 4, 8, 12 and 16
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to average score across weeks 36, 40 and 44
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 36, 40 and 44
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
Time Frame: Baseline to Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo
Time Frame: Baseline to Week 44
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 44
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
Time Frame: Baseline to Week 44
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 44
Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to average score across weeks 4, 8, 12 and 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 4, 8, 12 and 16
Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to average score across weeks 36, 40 and 44
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 36, 40 and 44
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to Week 16
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Baseline to Week 16
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen
Time Frame: Baseline to Week 16
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Baseline to Week 16
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo
Time Frame: Baseline to Week 44
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Baseline to Week 44
Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen
Time Frame: Baseline to Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo
Time Frame: Baseline to Week 44
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 44
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to average score across weeks 4, 8, 12 and 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 4, 8, 12 and 16
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to average score across weeks 36, 40 and 44
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 36, 40 and 44
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen
Time Frame: Baseline to Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo
Time Frame: Baseline to Week 44
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 44
Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to average score across weeks 4, 8, 12 and 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 4, 8, 12 and 16
Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
Time Frame: Baseline to Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
Time Frame: Baseline to average score across weeks 36, 40 and 44
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 36, 40 and 44
Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1
Time Frame: Baseline to Week 52
Baseline to Week 52
Number of Participants With AA (as Confirmed by Adjudication) - Year 2
Time Frame: First dose of study drug in Year 2 through week 104E
First dose of study drug in Year 2 through week 104E
Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2
Time Frame: Day 1 through week 104E (Extension)
Day 1 through week 104E (Extension)
Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1
Time Frame: Baseline to Week 52
Baseline to Week 52
Number of Participants With DA (as Confirmed by Adjudication) - Year 2
Time Frame: First dose of study drug in Year 2 through week 104E
First dose of study drug in Year 2 through week 104E
Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2
Time Frame: Day 1 through week 104E
Day 1 through week 104E
Number of Treatment Emergent Adverse Events (TEAEs) - Year 1
Time Frame: Baseline to Week 52
Baseline to Week 52
Number of TEAEs - Year 2
Time Frame: First dose of study drug in Year 2 through week 104E
First dose of study drug in Year 2 through week 104E
Number of TEAEs - Year 1 and Year 2
Time Frame: Day 1 through week 104E
Day 1 through week 104E
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1
Time Frame: Baseline to Week 52
Baseline to Week 52
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2
Time Frame: First dose of study drug in Year 2 through week 104E
First dose of study drug in Year 2 through week 104E
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2
Time Frame: Day 1 through week 104E
Day 1 through week 104E
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1
Time Frame: Baseline to Week 52
Baseline to Week 52
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2
Time Frame: First dose of study drug in Year 2 through week 104E
First dose of study drug in Year 2 through week 104E
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2
Time Frame: Day 1 through week 104E
Day 1 through week 104E
Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1
Time Frame: Baseline to Week 52
Baseline to Week 52
Number of Participants With Any Type of All-Cause JR in Year 2
Time Frame: First dose of study drug in Year 2 through week 104E
First dose of study drug in Year 2 through week 104E
Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2
Time Frame: Day 1 through week 104E
Day 1 through week 104E

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2017

Primary Completion (Actual)

September 9, 2019

Study Completion (Actual)

August 27, 2021

Study Registration Dates

First Submitted

May 18, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis, Knee

Clinical Trials on Fasinumab

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