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    Summary
    EudraCT Number:2015-003783-36
    Sponsor's Protocol Code Number:R475-PN-1523
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-05-17
    Trial 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 number2015-003783-36
    A.3Full title of the trial
    A Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients with Pain Due to Osteoarthritis of the Knee or Hip
    Estudio de fase III aleatorizado, doble ciego, multidosis y controlado con placebo para evaluar la seguridad a largo plazo y la eficacia de fasinumab en pacientes con dolor por gonartrosis y coxartrosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine the long-term safety and the efficacy of fasinumab for treatment of adults with pain from osteoarthritis of the knee or hip
    Estudio para evaluar la seguridad a largo plazo y la eficacia de fasinumab para el tratamiento de adultos con dolor por gonartrosis y coxartrosis
    A.4.1Sponsor's protocol code numberR475-PN-1523
    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.5.4Telephone number659516960
    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 number12
    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.IMP: 2
    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 number18
    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 knee or hip
    Dolor por gonartrosis y coxartrosis
    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
    Dolor de rodilla o cadera debido a una enfermedad de las articulaciones producida por la destrucción del cartílago articular y 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 19.0
    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 19.0
    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
    To describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed osteoarthritis (OA) of the knee or hip between baseline and week 16 (treatment period 1).
    Describir la seguridad y tolerabilidad de fasinumab, incluidos los acontecimientos adversos de interés especial (AAIE), en pacientes con dolor por gonartrosis o coxartrosis confirmadas radiológicamente entre el inicio del estudio y la semana 16 (período de tratamiento 1).
    E.2.2Secondary objectives of the trial
    To describe the safety and tolerability of fasinumab, including AESIs, in patients with pain due to radiographically-confirmed OA of the knee or hip between:
    - week 16 and week 52 (treatment period 2).
    - baseline and week 52 (overall study period).
    Describir la seguridad y tolerabilidad de fasinumab, incluidos los AAIE, en pacientes con dolor por gonartrosis o coxartrosis confirmadas radiológicamente entre:
    - la semana 16 y la semana 52 (período de tratamiento 2).
    - entre el inicio del estudio y la semana 52 (período total del estudio).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Onset of Pain Relief Sub-Study
    Primary objectives of the Onset of Pain Relief Sub-Study:
    To evaluate the efficacy of fasinumab compared to placebo as measured by:
    - Change from baseline at week 16 in the WOMAC pain subscale score
    - Change from baseline at week 16 in the WOMAC physical function subscale score
    - Change from baseline at week 16 in the Patient Global Assessment of OA score

    Secondary objectives of the Onset of Pain Relief Sub-Study:
    To evaluate the efficacy of fasinumab compared to placebo as measured by:
    - Change from baseline at weeks 1, 2, 4, 8, and 12 in the WOMAC pain subscale score & physical function subscale score and in the Patient Global Assessment of OA score
    - Change from baseline at weeks 1, 2, 4, 8, 12, and 16 using the Average Daily Walking Index Joint Pain Numeric Rating Scale and in the WOMAC total score & WOMAC stiffness subscale score
    - Change from baseline to week 16 in the percentage of patients who are responders based on WOMAC pain and physical function subscale scores and Patient Global Assessment scale scores defined by 30% reduction and 50% reduction
    - Change in response to therapy from baseline to week 16 assessed using the OMERACT-OARSI

    Primary efficacy endpoints for the onset of pain relief sub-study are:
    - Change from baseline through week 16 in WOMAC sub scale and total scores and Patient Global Assessment
    - Change from baseline through week 16 in Average Daily Walking Index Joint Pain Numeric Rating Scale
    - Change from baseline to week 16 of response to therapy using OMERACT-OARSI
    - Change from baseline to week 16 in the percentage of patients who are responders based on WOMAC pain and physical function subscale scores and Patient Global Assessment scale scores
    Subestudio de inicio del alivio del dolor
    Objetivos principales del Subestudio de inicio del alivio del dolor:
    Evaluar la eficacia de fasinumab en comparación con placebo medida por:
    - Cambio respecto al inicio en la semana 16 en la puntuación de la subescala de dolor del Índice de artrosis WOMAC
    - Cambio respecto al inicio en la semana 16 en la puntuación de la subescala de función física del WOMAC
    - Cambio respecto al inicio en la semana 16 en la puntuación de la Evaluación global por el paciente de la artrosis (OA)

    Objetivos secundarios del Subestudio de inicio del alivio del dolor:
    Evaluar la eficacia de fasinumab en comparación con placebo medida por:
    -Cambio respecto al inicio en las semanas 1, 2, 4, 8 y 12 en la puntuación de la subescala de dolor y de la función física del WOMAC, y en la puntuación de la Evaluación global por el paciente de la OA
    - Cambio respecto al inicio en las semanas 1, 2, 4, 8, 12 y 16 medido con la escala de valoración numérica del dolor diario promedio en la articulación de referencia al caminar, y en la puntuación total del WOMAC y en la puntuación de la subescala de rigidez del WOMAC
    - Cambio desde el inicio hasta la semana 16 en el porcentaje de pacientes con respuesta según las puntuaciones de las subescalas de dolor y función física del WOMAC y las puntuaciones de la escala de Evaluación global por el paciente, definidos como reducciones respectivas del 30 % y del 50 %
    - Cambio desde el inicio hasta la semana 16 en la respuesta al tratamiento evaluada por medio de la OMERACT-OARSI
    Los criterios de valoración principales de la eficacia para el subestudio de inicio del alivio del dolor
    -Cambio desde el inicio hasta la semana 16 en la puntuación de la subescala de dolor del WOMAC y en la puntuación de la EGP de la OA
    - Cambio desde el inicio hasta la semana 16 en EVN del dolor diario promedio en la articulación de referencia al caminar
    - Cambio en la respuesta al tratamiento desde el inicio hasta la semana 16 evaluado por medio de la OMERACT-OARSI
    - Cambio desde el inicio hasta la semana 16 en el porcentaje de pacientes con respuesta según las puntuaciones de las subescalas de dolor y función física del WOMAC y las puntuaciones de la escala de EGP
    E.3Principal inclusion criteria
    1) Male or female > 18 years of age at the screening visit
    2) Clinical diagnosis of OA of knee or hip based on ACR criteria with radiologic evidence of OA and moderate to severe pain in an eligible joint defined by WOMAC pain subscore
    3) Willing to discontinue current pain medication
    4) History of inadequate pain relief or intolerance to analgesics used for OA
    5) History of regular use of analgesic medications for OA
    1. Ser hombre o mujer de mayor de 18 años de edad en la visita de selección
    2. Diagnóstico clínico de gonartrosis o coxartrosis de acuerdo con los criterios del Colegio Estadounidense de Reumatología e indicios radiológicos de OA y tener dolor moderado o intenso definido por la subescala de dolor del WOMAC.
    3. Estar dispuesto a dejar la medicación actual para el dolor
    4.Tener antecedentes de alivio insuficiente del dolor o intolerancia a los analgésicos usados para la OA
    5. Tener antecedentes de uso regular de analgésicos para el dolor artrósico
    E.4Principal exclusion criteria
    1) Joint diseases or other underlying conditions that can confound with the study parameters
    2) Recent use of systemic or intra-articular corticosteroids
    3) Evidence of destructive arthropathy
    4) Evidence of autonomic or other neuropathy
    5) Scheduled for joint replacement surgery during the trial
    6) Other medical conditions that may interfere with participation or accurate assessments during the trial
    7) Pregnant or breastfeeding women
    1. Enfermedades de las articulaciones u otras condiciones subyacentes que pueden confundirse con los parámetros del estudio
    2. Reciente uso de corticosteroides sistémicos o intraarticulares
    3. Evidencia de artropatía destructiva
    4. Evidencia de neuropatía autónoma u otra neuropatía
    5.Tener programada una cirugía de artroplastia que deba realizarse durante el período del estudio
    6.Otras condiciones médicas que pueden interferir con la participación o correcta evaluación durante el estudio
    7.Ser una mujer embarazada o en período de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Safety monitoring including adverse event (AE) incidence, serious adverse event (SAE) incidence, AESI incidence, changes
    in safety laboratory analyses, and incidence of anti-fasinumab antibody formation between baseline and week 16 (treatment period 1).
    Supervisión de la seguridad, incluidas la incidencia de acontecimientos adversos (AA), la incidencia de acontecimientos adversos graves (AAG), la incidencia de AAIE, los cambios en las analíticas de seguridad y la incidencia de formación de anticuerpos contra fasinumab entre el inicio y la semana 16 (período de tratamiento 1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 16
    Semana 16
    E.5.2Secondary end point(s)
    - Safety monitoring through all adverse events incidences
    - Incidence of anti-fasinumab antibody formation
    - Supervisión de la seguridad a través de las incidencias de todos los acontecimientos adversos
    - Incidencia de formación de anticuerpos contra fasinumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 52
    Semana 52
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Efficacy only for the Onset of Pain Relief Sub-study
    Tolerabilidad
    Eficacia solo para el subestudio de inicio del alivio del dolor
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA67
    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
    Argentina
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Czech Republic
    Denmark
    Estonia
    France
    Germany
    Hong Kong
    Hungary
    Italy
    Lithuania
    Mexico
    Peru
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Sweden
    Ukraine
    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
    LVLS - study ends after 24 weeks of follow up
    Última visita del último paciente. El estudio finaliza tras las 24 semanas de seguimiento
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 3500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6500
    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 state142
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4500
    F.4.2.2In the whole clinical trial 10000
    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 tras la finalización del ensayo dependerá de las recomendaciones del médico 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 Decision2016-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-13
    P. End of Trial
    P.End of Trial StatusOngoing
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