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    Summary
    EudraCT Number:2018-004730-15
    Sponsor's Protocol Code Number:R5069-OA-1849
    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:2019-07-04
    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 number2018-004730-15
    A.3Full title of the trial
    A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN5069 in Patients with Pain due to Osteoarthritis of the Knee
    Estudio aleatorizado, doble ciego, de dosis múltiples, controlado con placebo, para evaluar la eficacia y seguridad de REGN5069 en pacientes con dolor debido a gonartrosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to examine the efficacy and safety of REGN5069 in patients with pain due to osteoarthritis of the knee
    Estudio para examinar la eficacia y seguridad de REGN5069 en pacientes con dolor debido a artrosis de rodilla
    A.4.1Sponsor's protocol code numberR5069-OA-1849
    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 pointKristie Ota
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    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 nameREGN5069
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREGN5069
    D.3.9.2Current sponsor codeREGN5069
    D.3.9.3Other descriptive nameREGN5069
    D.3.9.4EV Substance CodeSUB192514
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboLyophilisate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous 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
    Dolor debido a artrosis de rodilla
    E.1.1.1Medical condition in easily understood language
    Pain due to osteoarthritis of the knee
    Dolor debido a artrosis de rodilla
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    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 REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy.
    El objetivo principal del estudio es evaluar la eficacia de REGN5069 en comparación con placebo en pacientes con dolor debido a gonartrosis confirmada radiográficamente con antecedentes de alivio insuficiente del dolor articular o intolerancia al tratamiento analgésico en curso
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    - To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks
    - To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks
    - To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations
    Los objetivos secundarios del estudio son:
    -Caracterizar las concentraciones de REGN5069 funcional en suero a lo largo del tiempo cuando se trata a los pacientes durante un máximo de 12 semanas.
    -Evaluar la seguridad y tolerabilidad de REGN5069 en comparación con placebo cuando se trata a los pacientes durante un máximo de 12 semanas.
    -Medir los niveles de anticuerpos antifármaco (AAF) contra REGN5069 tras varias administraciones intravenosas (i.v.).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Moticon Digital Insole Device Sub-Study for Gait Assessments
    This sub-study will enroll approximately 13 patients per treatment group to obtain data on at least 10 patients per treatment group for a total of approximately 30 patients across the entire sub-study. For details on these procedures, participating sites will be provided with a Moticon digital insole device manual. The principle purpose of this sub-study is to assess functional mobility gait parameters as measured by the Moticon insole device in patients with pain due to OA of the knee without an analgesic treatment and in the presence of potential analgesic treatment. The study will also examine correlations of these gait parameters with the WOMAC pain subscale score.
    Subestudio de dispositivo de plantilla digital Moticon para evaluaciones de la marcha
    Este subestudio incluirá aproximadamente a 13 pacientes por grupo de tratamiento con el fin de obtener datos de al menos 10 pacientes por grupo de tratamiento con un total aproximado de 30 pacientes en todo el subestudio. Para obtener más datos sobre estos procedimientos, los centros participantes recibirán un manual del dispositivo de plantilla digital Moticon. El objetivo principal de este subestudio es evaluar los parámetros de marcha de movilidad funcional que mide el dispositivo de la plantilla Moticon en pacientes con dolor debido a osteoartrosis de la rodilla sin tratamiento analgésico y en la posible presencia de un tratamiento analgésico. El estudio también examinará las correlaciones de estos parámetros de la marcha con la puntuación de la subescala de dolor WOMAC
    E.3Principal inclusion criteria
    1. Generally in good health at the screening visit
    2. Body mass index (BMI) ≤39 kg/m2 at the screening visit
    3. Clinical diagnosis of OA of the knee based on the American College of Rheumatology criteria (Altman, 1986) with radiologic evidence of OA (K-L score ≥2) at the index joint at the screening visit
    4. Moderate-to-severe pain in the index joint
    5. A history of inadequate pain relief from or intolerance to analgesics used for OA
    1.Por lo general con buena salud en la visita de selección
    2.Índice de masa corporal (IMC) ≤39 kg/m2 en la visita de selección
    3.Diagnóstico clínico de artrosis de la rodilla basado en los criterios del Colegio Estadounidense de Reumatología (Altman, 1986) con indicios radiológicos de artrosis (puntuación K-L ≥2) en la articulación de referencia en la visita de selección
    4.Dolor moderado o grave en la articulación de referencia,
    5.Antecedentes de alivio del dolor insuficiente o intolerancia a los analgésicos utilizados para la artrosis
    E.4Principal exclusion criteria
    1. Diagnosis of systemic diseases that may affect joints
    2. History or presence of osteonecrosis, destructive arthropathy, neuropathic joint arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip dislocation
    (prosthetic hip dislocation is eligible), or knee dislocation (patella dislocation is eligible) at the screening visit. Presence of subchondral insufficiency fracture on screening films or
    MRI as assessed by the central imaging reader.
    3. Is scheduled for a joint replacement surgery to be performed during the study period
    4. Received an intra-articular injection of hyaluronic acid in any joint within 90 days prior to the screening visit
    5. Systemic (ie, IV, oral, or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit(topical, intranasal, or inhaled corticosteroids are permitted).
    6. History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy
    7. Significant concomitant illness including, but not limited to, psychiatric, cardiac, renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that, in the opinion of the investigator, would adversely affect the patient’s participation in the study
    8. History of myocardial infarction, acute coronary syndromes, transient ischemic attack, or cerebrovascular accident within 12 months prior to the screening visit

    Note: Other protocol defined inclusion/exclusion criteria apply
    1.Diagnóstico de enfermedades sistémicas que puedan afectar a las articulaciones.
    2.Antecedentes o presencia de osteonecrosis, artropatía destructiva, artropatía neuropática, fracturas patológicas en cualquier articulación de hombro, cadera o rodilla, dislocación de la cadera (en caso de dislocación de cadera protésica es apto) o luxación de rodilla (con luxación de rótula es apto) en la visita de selección. Presencia de fractura por insuficiencia subcondral en las radiografías o RM de selección evaluadas por el centro principal de diagnóstico por imagen.
    3.Tener programada una intervención de sustitución articular durante el periodo del estudio.
    4.Haber recibido una inyección intrarticular de ácido hialurónico en cualquier articulación en un plazo de 90 días antes de la visita de selección.
    5.Haber usado corticoesteroides sistémicos (es decir, i.v., orales o intramusculares) en los 30 días anteriores a la visita de selección. Haber usado corticoesteroides intrarticulares en la articulación de referencia en las 12 semanas anteriores a la visita de selección, o en cualquier otra articulación en los 30 días anteriores a la visita de selección (están permitidos los corticoesteroides tópicos, intranasales o inhalados).
    6. Antecedentes o presencia en la visita de selección de esclerosis múltiple, neuropatía del sistema autónomo, neuropatía diabética o neuropatía periférica de otro tipo.
    7.Enfermedad concomitante de importancia, entre otras, enfermedades psiquiátricas, cardíacas, renales, hepáticas, neurológicas, endocrinológicas, metabólicas o linfáticas, que en opinión del investigador puedan afectar negativamente a la participación del paciente en el estudio.
    8. Antecedentes de infarto de miocardio, síndrome coronario agudo, accidente isquémico transitorio o accidente cerebrovascular en los 12 meses anteriores a la visita de selección

    Nota: Consultar el protocolo para el resto de criterios de inclusión y exclusión aplicables.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the change from baseline to week 12 in the WOMAC pain subscale score in patients treated with REGN5069 compared to patients treated with placebo.
    El criterio de valoración principal del estudio es el cambio desde el inicio hasta la semana 12 en la puntuación de la subescala del dolor del Índice de artrosis de Western Ontario y McMaster (Western Ontario and McMaster Osteoarthritis Index, WOMAC) en los pacientes tratados con REGN5069 en comparación con los pacientes tratados con placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12
    Desde el inicio hasta la semana 12
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints of the study are:
     Change from baseline to week 12 in the WOMAC total score (based on the full survey) in patients treated with REGN5069 compared to patients treated with placebo*
     Change from baseline to week 12 in the WOMAC physical function subscale score in patients treated with REGN5069 compared to patients treated with placebo*
     Change from baseline to week 12 in the Patient Global Assessment score in patients treated with REGN5069 compared to patients treated with placebo*
     Change from baseline to week 12 in WOMAC stiffness subscale score in patients treated with REGN5069 compared to patients treated with placebo*
     Percentage of patients treated with REGN5069, compared to that of patients treated with placebo, who had a response at week 12, with response defined as an improvement
    by ≥30% in the WOMAC pain subscale scores*


    The secondary safety endpoints of the study are:
    The incidence of treatment-emergent adverse events (TEAEs) in patients treated with
    REGN5069 compared to patients treated with placebo throughout the study duration**
    The incidence of imaging abnormalities consistent with accelerated arthropathies as
    assessed by X-ray and MRI in patients treated with REGN5069 compared to patients
    treated with placebo throughout the study duration**
    Presence of anti-REGN5069 antibody development in patients treated with REGN5069
    compared to patients treated with placebo throughout the study duration**
    Los criterios de valoración secundarios de la eficacia del estudio son:
    •Cambio desde el inicio hasta la semana 12 en la puntuación total del WOMAC (según el cuestionario completo) en los pacientes tratados con REGN5069 en comparación con los pacientes tratados con placebo*.
    •Cambio desde el inicio hasta la semana 12 en la puntuación de la subescala de función física del WOMAC en los pacientes tratados con REGN5069 en comparación con los pacientes tratados con placebo*.
    •Cambio desde el inicio hasta la semana 12 en la puntuación de la evaluación global por parte del paciente en los pacientes tratados con REGN5069 en comparación con los pacientes tratados con placebo*.
    •Cambio desde el inicio hasta la semana 12 en la puntuación de la subescala de rigidez del WOMAC en los pacientes tratados con REGN5069 en comparación con los pacientes tratados con placebo*.
    •Porcentaje de pacientes tratados con REGN5069 en comparación con los pacientes tratados con placebo que experimentaron una respuesta en la semana 12, con la respuesta definida como una mejoría >30 % en las puntuaciones de la subescala de dolor del WOMAC.*
    Los criterios de valoración secundarios de la seguridad del estudio son:
    •Incidencia de acontecimientos adversos surgidos durante el tratamiento en los pacientes tratados con REGN5069 en comparación con los pacientes tratados con placebo a lo largo de la duración del estudio**.
    •Incidencia de anomalías en las imágenes coherentes con aceleración de artropatías según lo determinado por radiografía y resonancia magnética en los pacientes tratados con REGN5069 en comparación con los pacientes tratados con placebo a lo largo de la duración del estudio**.
    •Presencia de desarrollo de anticuerpos anti-REGN5069 en los pacientes tratados con REGN5069 en comparación con los pacientes tratados con placebo a lo largo de la duración del estudio**.
    E.5.2.1Timepoint(s) of evaluation of this end point
    *Baseline to Week 12
    **Through study completion (36 weeks)
    *Desde el inicio hasta la semana 12
    ** Hasta completar el estudio (36 semanas)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Bulgaria
    Czech Republic
    Georgia
    Germany
    Moldova, Republic of
    Poland
    Romania
    Slovakia
    Spain
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months22
    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: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 96
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 240
    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)
    None
    Ninguno
    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 Decision2019-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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