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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-004921-33
    Sponsor's Protocol Code Number:R475-OA-1758
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-20
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-004921-33
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect of fasinumab compared to placebo on peripheral nerves in patients with pain due to OA of the hip or knee.
    A.4.1Sponsor's protocol code numberR475-OA-1758
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown, NY
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFasinumab
    D.3.2Product code REGN475
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFasinumab
    D.3.9.1CAS number 1190239-42-9
    D.3.9.2Current sponsor codeREGN475
    D.3.9.3Other descriptive nameFASINUMAB
    D.3.9.4EV Substance CodeSUB128096
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain due to osteoarthritis of the hip or knee
    E.1.1.1Medical condition in easily understood language
    Pain of the knee or hip due to a joint disease that results from breakdown of joint cartilage and underlying bone
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020108
    E.1.2Term Hips osteoarthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the effect of fasinumab compared to placebo on peripheral nerves in patients with pain due to osteoarthritis of the hip or knee.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    - To evaluate the efficacy of fasinumab compared to placebo in patients with pain due to osteoarthritis of the hip or knee
    - To evaluate the safety and tolerability of fasinumab compared to placebo in patients with pain due to osteoarthritis of the hip or knee
    - To characterize the concentrations of fasinumab in serum in patients with pain due to osteoarthritis of the hip or knee
    - To evaluate the immunogenicity of fasinumab in patients with pain due to osteoarthritis of the hip or knee
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Genomics Sub-study
    The purpose of the genomic analyses is to identify genomic associations with collagen and bone turnover, osteoarthritis, pain, and response to fasinumab.
    E.3Principal inclusion criteria
    A patient must meet the following criteria to be eligible for inclusion in the study:
    1.Male and female patients ≥18 years of age at screening visit
    2.Provide signed informed consent signed by study patient or legally acceptable representative
    3.Body mass index ≤39 at screening visit
    4.A clinical diagnosis of osteoarthritis of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of osteoarthritis (K-L score ≥2 for the index joint) at the screening visit, with the following definitions:
    •The index joint is defined as the joint with osteoarthritis under evaluation for this study
    •A joint previously treated with JR surgery cannot be the index joint
    •A joint previously surgically modified within the past year cannot be the index joint (with the exception of cruciate ligament reconstruction surgery, patellar fracture repair surgery, or meniscal repair)
    •If a patient has a K-L score of ≥2 at more than 1 knee or hip joint, the index joint is the joint with the greatest WOMAC pain subscore at the screening visit
    •If 2 or more knee or hip joints have a K-L score of ≥2 and the same WOMAC pain subscore, the index joint is the joint with the greater K-L score
    •If 2 or more joints have a K-L score of ≥2, the same WOMAC pain subscores, and the same K-L scores, then the investigator may choose 1 of these joints as the index joint
    5.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
    6.Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments (paracetamol/acetaminophen 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])
    7.A history of at least 12 weeks of analgesics use for pain due to osteoarthritis of the knee or hip, as defined by
    a.Inadequate pain relief from acetaminophen/paracetamol AND
    b.Intolerance to or inadequate pain relief from at least 1 oral NSAID AND
    c.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
    8.A history of regular use of analgesic medications for osteoarthritis pain (defined as an average of 4 days per week over the 4 weeks prior to the screening visit), including oral NSAIDs, selective cyclooxygenase 2 inhibitors, opioids, paracetamol/acetaminophen, or combinations thereof
    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
    E.4Principal exclusion criteria
    Key Exclusion criteria:
    1.History or presence at the screening visit of non-osteoarthritis 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 osteoarthritis 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.Patient is not a candidate for MRI
    6.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 one eventually became necessary
    7.Patients with abnormal nerve conduction parameters at any nerve based on standards detailed in the study manual and according to the eligibility report provided by the central reader
    8.Patients receiving, or who plan to receive, interventions, devices, or medications that alter nerve conduction or are contraindicated in patients undergoing nerve conduction studies (eg, edema, tarsal tunnel syndrome)
    9.History or presence at the screening visit of autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy and complex regional pain syndrome
    10.History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy (Shy-Drager syndrome)
    11.Known allergy or sensitivity to monoclonal antibodies
    12.Poorly controlled diabetes (defined as any single value of hemoglobin A1c [HbA1c] >9.0%) at the screening visit
    13.Known history of human immunodeficiency virus (HIV) infection
    14.Known history of ocular herpes simplex virus, herpes simplex virus pneumonia, or herpes simplex virus encephalitis
    15.History of sickle cell disease, including sickle cell anemia and β-thalassemia
    16.Confirmed elevated screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5 times the upper limit of normal (ULN)
    17.Resting heart rate of <50 beats per minute (bpm) or >100 bpm (by vital sign assessment or as captured during electrocardiogram [ECG] assessment) at the screening or randomization visits
    30.Use of a monoamine reuptake inhibitor, tricyclic antidepressants, selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors for treatment of pain within 4 weeks prior to the screening visit
    31.Has positive urine drug test results during screening (eg, amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates), unless in the opinion of the investigator, the positive test results may be due to the patient’s current permitted medications.
    32.History of (within 5 years prior to the screening visit) or current alcoholism, alcohol abuse, substance abuse, or abuse of prescription pain medication
    33.History of cannabis use for the treatment of pain within the past 6 months prior to the screening visit
    34.Ongoing participation in a clinical research study evaluating another investigational drug or having received another investigational product within 30 days or 5 half-lives of the screening visit, whichever is longer
    35.Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies or participation in a clinical trial evaluating anti-NGF antibodies
    36.Member of the clinical site study team and/or his/her immediate family, unless prior approval granted by the sponsor
    37.Pregnant or breastfeeding women
    38.Women of childbearing potential who have a positive pregnancy test result or do not have their pregnancy test result at baseline
    39.Women of childbearing potential who are unwilling to practice highly effective contraception prior to start of the first treatment, during the study, and for at least 20 weeks after the last dose.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of the study are:
    - Change from baseline to week 16 in peroneal motor nerve conduction velocity
    - Change from baseline to week 16 in peroneal motor nerve action potential amplitude
    - Change from baseline to week 16 in sural sensory nerve conduction velocity
    - Change from baseline to week 16 in sural sensory nerve action potential amplitude
    - Change from baseline to week 16 in ulnar sensory nerve conduction velocity
    - Change from baseline to week 16 in ulnar sensory nerve action potential amplitude
    E.5.1.1Timepoint(s) of evaluation of this end point
    at week 16
    E.5.2Secondary end point(s)
    The secondary endpoints of the study are:
    - Change from baseline to week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score
    - Change from baseline to week 16 in WOMAC physical function subscale score

    Additional safety endpoints in this study are:
    - Incidence of AA (as confirmed by an independent adjudication committee)
    - Incidence of DA (as confirmed by an independent adjudication committee)
    - Incidence of treatment-emergent adverse event (TEAEs)
    - Incidence of SNS dysfunction (as diagnosed after consultation with an appropriate
    specialist, such as a neurologist and/or cardiologist)
    - Incidence of peripheral sensory AEs that require a neurology or other specialty consultation
    - Incidence of all-cause joint replacement (JR) surgeries through week 16 and through
    the end of follow-up period (week 36)
    - Incidence of JRs at telephone survey approximately 52 weeks after last dose of study drug
    E.5.2.1Timepoint(s) of evaluation of this end point
    at week 16
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Poland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the last phone contact
    for the last patient. The last phone contact will be conducted at 52 weeks following the last dose of study drug.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 180
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Treatment after trial completion will be dependent on recommendations from the patient's personal physician.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-07
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