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    Summary
    EudraCT Number:2017-001943-12
    Sponsor's Protocol Code Number:R475-PN-1612
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-03-28
    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 ConcernedSpain - AEMPS
    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
    Estudio en fase III, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de fasinumab en pacientes con dolor lumbar crónico de moderado a intenso y artrosis de cadera o rodilla
    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
    Estudio para evaluar la seguridad y la eficacia de fasinumab en comparación con placebo en pacientes con dolor lumbar crónico y artrosis de cadera o rodilla
    A.3.2Name or abbreviated title of the trial where available
    FACT CLBP 1
    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
    Dolor debido a artrosis y dolor lumbar crónico
    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
    Dolor lumbar crónico y dolor de cadera o rodilla debido a debido a una enfermedad de la articulación que resulta de la ruptura del cartílago articular y el hueso subyacente
    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.
    El objetivo principal del estudio es evaluar la eficacia de fasinumab para aliviar el dolor lumbar crónico (DLC) en comparación con el placebo en pacientes con diagnóstico clínico de DLC no radicular de moderado a intenso y artrosis (A) de rodilla o cadera cuando se tratan durante un periodo máximo de 16 semanas.
    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
    •Evaluar la seguridad y tolerabilidad de fasinumab en comparación con el placebo cuando se trata a pacientes con diagnóstico clínico de DLC no radicular de moderado a intenso y artrosis de rodilla o cadera durante un periodo máximo de 16 semanas.
    •Caracterizar las concentraciones séricas de fasinumab a lo largo del tiempo cuando se trata a pacientes con diagnóstico clínico de DLC no radicular de moderado a intenso y artrosis de rodilla o cadera durante un periodo máximo de 16 semanas.
    •Evaluar la inmunogenicidad de fasinumab cuando se trata a pacientes con diagnóstico clínico de DLC no radicular de moderado a intenso y artrosis de rodilla o cadera durante un periodo máximo de 16 semanas.
    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
    Sub-estudio genómico
    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
    1.Pacientes de ambos sexos de ≥18 años en la visita de selección.
    2.Índice de masa corporal ≤39 en la visita de selección.
    3.Diagnóstico clínico de DLC no radicular de moderado a grave durante ≥3 meses (antes de la visita de selección) definido por lo siguiente:
    a.Categoría 1 (dolor sin radiación) o 2 (dolor con radiación proximal por encima de la rodilla) según la clasificación Quebec Task Force.
    b.Dolor primario entre la 12.a vértebra dorsal y los surcos de glúteos inferiores.
    c.Tanto en la visita de selección como en la de aleatorización, una puntuación de la EVN de la IDL ≥4 durante las 24 horas anteriores.
    d.Puntuación media diaria de la IDL ≥4 durante el periodo anterior a la aleatorización.
    e.EGP del DL regular, mala o muy mala en la visita de selección.
    4.Diagnóstico clínico de artrosis (A) al menos en 1 articulación de la cadera o de rodilla según los criterios del Colegio Estadounidense de Reumatología con pruebas radiográficas de A (K-L ≥2) en la selección, según lo descrito en la sección 8.2.1.8.
    5.Antecedentes de alivio insuficiente del DLC con tratamientos no farmacológicos (p. ej., ejercicio, fisioterapia, acupuntura o rehabilitación interdisciplinar).
    6.Antecedentes de alivio del dolor insuficiente o intolerancia a los analgésicos utilizados para el DLC, definidos por lo siguiente:
    a.Alivio del dolor insuficiente con paracetamol.
    b.Intolerancia o alivio del dolor insuficiente al menos con 1 AINE oral.
    c.Intolerancia o alivio del dolor insuficiente al menos con 1 opioide o tramadol, negativa al tratamiento con opioides por algún motivo aceptable desde el punto de vista médico o falta de acceso al tratamiento con opioides.
    7.Antecedentes de uso regular de analgésicos para el DL (definido por un promedio de 4 días a la semana durante las 4 semanas anteriores a la visita de selección), incluyendo AINE, inhibidores selectivos de la ciclooxigenasa 2, opioides, paracetamol o combinaciones de los mismos.
    8.Voluntad para dejar los analgésicos en curso y cumplir los requisitos del estudio relativos a los tratamientos de rescate (el paracetamol se tomará según sea necesario con una dosis diaria máxima de 2500 mg (países con disponibilidad de comprimidos/cápsulas de 500 mg) o 2600 mg (países con disponibilidad de comprimidos/cápsulas de 325 mg).
    9.Voluntad de mantener los niveles actuales de actividad y ejercicio físico durante todo el estudio.
    10.Voluntad de someterse a una artroplastia si es necesario.
    11.Voluntad y posibilidad de cumplir con las visitas programadas al centro y con los procedimientos relacionados con el estudio, y voluntad de facilitar información de seguimiento relacionada con las posibles artroplastias que tengan lugar durante el periodo de tiempo previsto de participación en el estudio.
    12.Consentimiento para permitir que todas las radiografías y todos los historiales médicos/quirúrgicos/de ingresos de atención sanitaria recibida en otros centros antes y durante el periodo del estudio se compartan con el investigador.
    13.Consentimiento informado firmado.
    14.Ser capaz de comprender y cumplimentar los cuestionarios relacionados con el estudio
    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.
    1Omisión de la entrada de datos de la EVN de la IDL durante el periodo anterior a la aleatorización, def por + de 2 entradas faltantes. 2Antecedentes de radiculopatía lumbosacra de categoría >2 según clasif.Quebec Task en los 2 años anter a la selección. 3No es candidato a RM.4Indicios en RM inicial de columna lumbar de estenosis del conducto vertebral grave, hernia discal compresión nerviosa considerable, fractura vertebral rete, proceso destruc activo o inestabilidad segmentaria 5Anteced de traumatismo grave o cirugía de espalda 6 meses anter a selección
    6Antec/presencia síndrome piriforme.7Indemniz acc laborales,litigio,discapacidad o acuerdo monetario relac con DLC. 8Antec o artropatía en pruebas de imagen,fractura reciente,fractura recte sobrecarga, artropatía neuropática, luxación de cadera,luxa de rodilla, displasia cadera congénita con artropatía degenerativa,quistes subcondrales extendidos,indicios fragmentación o colapso óseo o tumor metas 1ario salvo condromas/fracturas patológicas durante selección.9Antec o presencia en selección de artropatía inflam distinta de la A .10Antec de ingreso hospitalario x depresión o intento de suicidio en 2 años anteriores a selección o depresión mayor grave activa en selección.11Puntuación depresión de Beck - II (BDI-II) ≥29 en selección.12Uso inhibidores recaptación monoamina,antidepresivos tricíclicos,inhibidores selectivos recaptación de serotonina e inhibidores recaptación serotonina y noradrenalina para tto del DLC en las 4 semanas antes a selección.13Uso de opioides de liberación lenta o controlada,fentanilo transdérmico o metadona en 3 meses antes a selección.14Uso de opioides con dosis equivalente a la morfina ≥30 mg dia durante + de 4 días semana.15Uso corticoesteroides sistémicos o cortico intraarticulares en cualquier articulación en 30 días antes a selección.16Inyecciones epidurales con corticos en los 3 meses antes a visita de selección.17Inyecciones bótox para el DL en 6 meses antes a la selección.18Antec canabismo para tto del DL en 6 meses antes a selección.19Alcoholismo,abuso bebidas alcohólicas,toxicomanía o abuso de analgésicos con receta en los 5 años antes a la selección o en curso.20Artroplastia programada en el periodo del estudio.21Signos y síntomas de síndrome túnel carpiano en los 6 meses antes a selección. 22Antec o presencia en selección de neuropatía neurovegetativa,diabética o periférica de otro tipo,incluyendo distrofia simpática refleja.23Indicios neuropatía neurovegetativa.24Antecedentes o diagnóstico de síndrome de insufic neurovegetativa crónica, incluyendo la insufic neurovegetativa pura y la atrofia multisistémica.25.Diabetes mal controlada (def por hemoglobina A1c [HbA1c] >9,0 %) en selección. 26.Aumento ALT o AST de ≥2,5 × LSN en selec. 27Frec cardíaca en reposo <50 lpm o >100 lpm 28Antecedentes o presencia bloqueo auriculoventricular de 2º o 3er grado,bloqueo auriculoventricular de 1er grado con complejo anómalo de ondas Q, R y S (QRS) o bloqueo bifascicular en el ECG en selección.29Antecedentes o presencia de hipotensión ortostática, def en 8.2.3.8, en selecc, anteriores a aleatorización o iniciales.30Antec de hipertensión mal controlada, def por: a.Tensión ≥180 mm o tensión diastólica ≥110 mm en selecc.b.Tensión sistólica 160 mm a 179 mm o tensión diastólica 100 mm a 109 mm en selec Y antecedentes de daño orgánico especif .31Insufic cardíaca congestivaestadio III o IV según clasif Asoc Neoyorquina Cardiología (Dolgin,94).32Accid isquémico transitorio o accid cerebrovascular 12 meses antes a selecc o infarto de miocardio o síndrome coronario agudo en 6 meses antes a selecc.33Antec conocidos infecc VIH.34Antec conocidos herpes simple ocular, neumonía herpes simple o encefalitis herpes simple.35Antec conocidos de infecc hepB. Ptes con antec hepaB son aptos si constancia de resultado - enantígeno de superficie de hepa B y de resultado + anticpos antígeno de superficie del virus de hepaB.36Antec de infec por virus de hepa C. Los ptes con antec de hepa C son aptos si resultado - en prueba ARN de virus hepa C.37Antec o presencia de neoplasia maligna en 5 años anteriores a la selección, salvo aquellos pacientes con tto satisfactorio y ausencia de recurrencia durante >1 año carcinoma basocelular o cél escamosas de la piel o cáncer cervicouterino in situ.38Nueva enf grave diagnosticada en los 2 meses antes a selección.39Enf conctante de importancia, enf psiquiátricas, cardíacas, renales,hepáticas, neurológicas,endocrinológicas,metabólicas o linfáticas. 40Alergia o sensib doxiciclina o comp. relacionados,excip o acpos monoclonales.41Participacion investigación clínica otro fco experimental o fco 30 días, el periodo que sea más largo.42Expos a aticpos contra NGF antes de selección o sensibilidad conocida o intolerancia a ellos. 43Miembro del equipo en el centro clínico o familiares.44Embarazadas o en lactancia.45Mujeres MCC con resultado + en prueba embarazo.46 MCC no dispuestas a tomar medidas anticonceptivas
    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.
    El criterio de valoración principal es la variación desde el inicio hasta la semana 16 en la puntuación del promedio diario de la EVN de la IDL en los pacientes tratados con fasinumab en comparación con los tratados con el placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    at week 16
    en semana 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
    Los criterios de valoración secundarios del estudio son:
    •Variación desde el inicio hasta la semana 16 en la puntuación total del RMDQ en los pacientes tratados con fasinumab en comparación con los tratados con el placebo.
    •Variación desde el inicio hasta la semana 16 en la puntuación de la EGP del DLC en los pacientes tratados con fasinumab en comparación con los tratados con el placebo.
    •Proporción de pacientes que responden al tratamiento, definida por una reducción ≥ 30 % en la semana 16 con respecto al valor inicial en el promedio diario de la puntuación de la EVN de la IDL en los pacientes tratados con fasinumab en comparación con los tratados con el placebo.
    •Variación desde el inicio hasta la semana 16 en la puntuación de la interferencia del dolor del BPI-sf en los pacientes tratados con fasinumab en comparación con los tratados con el placebo.

    Los criterios de valoración de la seguridad de este estudio son:
    •Incidencia de AC (según lo confirmado por un comité de validación independiente).
    •Incidencia de artropatías destructivas (AD) (según lo confirmado por un comité de validación independiente).
    •Incidencia de acontecimientos adversos surgidos durante el tratamiento (AAST).
    •Incidencia de disfunciones del SNS (según el diagnóstico tras la interconsulta con el especialista correspondiente, como un neurólogo o cardiólogo).
    •Incidencia de AA sensitivos periféricos que requieran la interconsulta con neurología.
    •Incidencia de artroplastias por cualquier causa hasta la semana 16 y hasta el fin del periodo de seguimiento (semana 36).
    •Incidencia de artroplastias obtenida en la encuesta telefónica de aproximadamente 52 semanas después de la última dosis del fármaco del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at week 16
    en semana 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 concerned6
    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
    El fin de estudio para este estudio viene definido como el ultimo contacto telefonico del último paciente. El último contacto telefonico será realizado aproximadamente 52 semanas después de la última dosis de la medicación de estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    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 state55
    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.
    El tratamiento después de la finalización del ensayo dependerá de las recomendaciones del médico personal del paciente
    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 Decision2018-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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