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    Summary
    EudraCT Number:2017-001943-12
    Sponsor's Protocol Code Number:R475-PN-1612
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-27
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2017-001943-12
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients with Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee
    3. fázisú, randomizált, kettős-vak, placebokontrollos vizsgálat a fazinumab hatásosságának és biztonságosságának értékelésére a mérsékelt-súlyos krónikus alsó háti fájdalomtól és a csípő vagy a térd osteoarthritisétől szenvedő betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine the safety and the efficacy of fasinumab compared to
    placebo for treatment of adults with chronic back pain and osteoarthritis
    of the hip or knee
    A.3.2Name or abbreviated title of the trial where available
    FACT CLBP 1
    A.4.1Sponsor's protocol code numberR475-PN-1612
    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 number6
    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 and chronic lower back pain
    E.1.1.1Medical condition in easily understood language
    Chronic pain of the lower back and 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 efficacy of fasinumab in relieving CLBP as
    compared to placebo in patients with a clinical diagnosis of moderate-to-severe non-radicular
    CLBP and OA of the knee or hip when treated for up to 16 weeks.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    -To evaluate the safety and tolerability of fasinumab compared to placebo when
    patients with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA
    of the knee or hip are treated for up to 16 weeks
    -To characterize the concentrations of fasinumab in serum over time when patients
    with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the
    knee or hip are treated for up to 16 weeks
    -To evaluate the immunogenicity of fasinumab when treated for up to 16 weeks in
    patients with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA
    of the knee or hip
    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
    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. Body mass index ≤39 at screening visit
    3. Clinical diagnosis of non-radicular moderate-to-severe CLBP for ≥3 months (prior to
    screening visit) as defined by the following:
    a. Quebec taskforce category 1 (pain without radiation) or 2 (pain with proximal
    radiation above the knee), and
    b. Primary pain between 12th thoracic vertebra and lower gluteal folds, and
    c. At both screening and randomization visit, a LBPI NRS score ≥4 over previous
    24 hours, and
    d. Mean daily LBPI score ≥4 during pre-randomization period, and
    e. PGA of LBP of fair, poor, or very poor at screening visit
    4. Clinical diagnosis of OA in at least 1 hip or knee joint based on the American College of
    Rheumatology Criteria with radiographic evidence of OA (K-L ≥2) at screening as
    described in Section 8.2.1.8
    5. History of inadequate relief of CLBP from non-pharmacologic therapy (eg, exercise,
    physical therapy, acupuncture, or multidisciplinary rehabilitation)
    6. History of inadequate pain relief or intolerance to analgesics used for CLBP defined by:
    a. Inadequate pain relief from paracetamol/acetaminophen, and
    b. Intolerance or inadequate pain relief from at least 1 oral NSAID, and
    c. Intolerance or inadequate pain relief from at least 1 opioid or tramadol, unwillingness
    to take opioid therapy for a medically acceptable reason, or lack of access to opioid
    therapy
    7. History of regular use of analgesic medications for LBP pain (defined as an average of 4
    days per week over the 4 weeks prior to the screening visit), including NSAIDs, selective
    cyclooxygenase 2 inhibitors, opioids, paracetamol/acetaminophen, or combinations
    thereof
    8. 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)
    9. Willing to maintain current activity and exercise levels throughout the study
    10. Willing to undergo joint replacement (JR) surgery, if necessary
    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. 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
    13. Provide signed informed consent
    14. Able to understand and complete study-related questionnaires
    E.4Principal exclusion criteria
    Key exclusion criteria:
    1. Non-compliance with the LBPI NRS data entries during the pre-randomization period, as
    defined by more than 2 missing entries
    2. History of Quebec taskforce category >2 (pain with proximal radiation above the knee)
    lumbosacral radiculopathy within the past 2 years prior to the screening visit
    3. Patient is not a candidate for MRI
    4. Evidence on baseline lumbar spine MRI (or lumbar X-ray, if requested) of severe spinal
    stenosis, disc herniation with substantial nerve compression, recent vertebral fracture, an active destructive process or marked segmental instability (eg, severe scoliosis, bone
    marrow edema, or Modic type 1 change)
    5. History of major trauma or back surgery in the past 6 months prior to the screening visit
    6. History or presence of pyriformis syndrome
    7. Current or pending worker’s compensation, litigation, disability, or any other monetary
    settlement related to LBP
    8. History or presence on imaging of arthropathy (osteonecrosis, subchondral insufficiency
    fracture, rapidly progressive OA type 1 or type 2), recent 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 pathological fractures
    during the screening period
    9. History or presence at the screening visit of non-OA inflammatory joint disease (eg,
    rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudo-gout, gout,
    spondyloarthropathy, 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)
    10. History of hospital admission for depression or suicide attempt within 2 years or active,
    severe major depression at screening
    11. Beck Depression Inventory - II (BDI-II) score ≥29 at screening
    12. Use of a monoamine reuptake inhibitor, tricyclic antidepressants, selective serotonin
    reuptake inhibitors and serotonin norepinephrine reuptake inhibitors for treatment of
    CLBP within 4 weeks prior to the screening visit
    13. Use of extended-release or controlled-release opioids (eg, oxycontin), transdermal
    fentanyl or methadone within 3 months prior to the screening visit
    14. Use of opioids with a morphine equivalent dose of ≥30 mg per day for more than 4 days
    per week
    15. Use of systemic (ie, oral or intramuscular) corticosteroids or intra-articular
    corticosteroids in any joint within 30 days prior to the screening visit (topical, intranasal,
    and inhaled corticosteroids are permitted)
    16. Epidural steroid injections within 3 months prior to the screening visit
    17. Botox injections for LBP within 6 months prior to the screening visit
    44. Pregnant or breastfeeding women
    45. Women of childbearing potential (WOCBP)* who have a positive pregnancy test result
    or do not have their pregnancy test result at baseline
    46. Women of childbearing potential who are unwilling to practice highly effective
    contraception prior to the initial dose/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 endpoint is change in the daily average LBPI NRS score from baseline to week 16
    in patients treated with fasinumab compared to patients treated with placebo.
    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 RMDQ total score in patients treated with
    fasinumab compared to patients treated with placebo
    - Change from baseline to week 16 in Patient Global Assessment (PGA) of LBP score
    in patients treated with fasinumab compared to patients treated with placebo
    -Proportion of patients who are responders as defined by ≥30% reduction from
    baseline to week 16 in daily average LBPI NRS score in patients treated with
    fasinumab compared to patients treated with placebo
    -Change from baseline to week 16 in the Brief Pain Inventory Short Form (BPI-sf)
    pain interference score in patients treated with fasinumab compared to patients treated
    with placebo

    The 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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
    Canada
    Czech Republic
    Hungary
    Poland
    Romania
    South Africa
    Spain
    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 for this study is defined as the last phone contact
    for the last patient. The last phone contact will be conducted approximately 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 years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 765
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 255
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 1020
    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 Decision2018-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-05-03
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