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    EudraCT Number:2013-003752-21
    Sponsor's Protocol Code Number:SA-307JG
    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:2015-03-11
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-003752-21
    A.3Full title of the trial
    A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder
    Ensayo clínico de fase tardía para investigar la eficacia y seguridad de SA237 en pacientes con Neuromielitis Óptica y Espectro de Trastornos de la Neuromielitis Óptica.
    A.4.1Sponsor's protocol code numberSA-307JG
    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 SponsorChugai Pharmaceutical Co. Ltd
    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 supportChugai Pharmaceutical Co. Ltd
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChugai Pharma Europe Ltd
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressMulliner House, Flanders Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW4 1NN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442089875600
    B.5.5Fax number442089875616
    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.3.2Product code SA237
    D.3.4Pharmaceutical form Solution for injection
    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 INNFully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody
    D.3.9.1CAS number Not known
    D.3.9.2Current sponsor codeSA237
    D.3.9.3Other descriptive nameFully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    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
    Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
    Neuromielitis Óptica (NMO) y Espectro de Trastornos de la Neuromielitis Óptica (ETNMO)
    E.1.1.1Medical condition in easily understood language
    Central Nervous System disorder causing primarily swelling and inflammation of the eye nerves and the spinal cord
    Trastorno del Sistema Nervioso Central que causa principalmente tumefacción e inflamación de los nervios del ojo y de la medulla espinal.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10029322
    E.1.2Term Neuromyelitis optica
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of SA237 compared with placebo in patients with NMO and NMOSD
    Evaluar la eficacia del SA237 en comparación con placebo en pacientes con neuromielitis óptica (NMO) o el espectro de trastornos de la neuromielitis óptica (ETNMO).
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet the following criteria for study entry:
    1. Patients must be diagnosed as having either:
    a. NMO as defined by 2006 criteria?, *, or
    b. NMOSD as defined by either of the following Wingerchuk 2007 criteria with anti-aquaporin 4 antibody (AQP4Ab) seropositive status at screening?.
    i) Idiopathic single or recurrent events of longitudinally extensive myelitis (?3 vertebral segment spinal cord magnetic resonance imaging [MRI] lesion)
    ii) Optic neuritis: recurrent or simultaneous bilateral
    ? For patients aged12 to 17 years, anti-AQP4Ab status at screening? must be seropositive.
    ? Screening result is based on either the blood sample data collected at screening visit, or the blood sample data collected before the screening visit and measured by Sponsor?s designee for analysis.
    2. Clinical evidence of at least 2 documented relapses (including first attack) in the last 2 years prior to screening, at least one of which has occurred in the 12 months prior to screening.
    3. Expanded Disability Status Scale (EDSS) score from 0 to 6.5 inclusive at screening.
    4. Age 12 to 74 years, inclusive at the time of informed consent.
    5. One of the following baseline treatments for relapse prevention must be at stable dose as a monotherapy for 8 weeks prior to baseline**:
    a. Azathioprine.
    b. Mycophenolate mofetil.
    c. Oral corticosteroids.
    ** For patients aged 12 to 17 years, either of the following baseline treatments for relapse prevention can be allowed:
    d. Azathioprine + oral corticosteroids.
    e. Mycophenolate mofetil + oral corticosteroids.
    6. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol.

    *According to Wingerchuk et al. 2006, a diagnosis of NMO requires all of the following three criteria:
    I. Optic neuritis
    II. Acute myelitis
    III. At least two of three supportive criteria:
    - Contiguous spinal cord lesion identified on an MRI scan extending over 3 vertebral segments
    - Brain MRI not meeting diagnostic criteria for multiple sclerosis
    - NMO-immunoglobulin G seropositive status
    Los pacientes deben cumplir los siguientes criterios para entrar en el estudio:
    1. Diagnóstico de:
    a. NMO según su definición por los criterios de 2006?, *, o bien
    b. ETNMO según su definición por alguno de los criterios de Wingerchuk de 2007 que se señalan a continuación, junto con seropositividad para anticuerpos antiacuaporina 4 (AQP4) en la selección?.
    i) Episodios idiopáticos aislados o recurrentes de mielitis con extensión longitudinal (lesión medular ?3 segmentos vertebrales en la resonancia magnética [RMN])
    ii) Neuritis óptica: recurrente o bilateral simultánea
    ? Los pacientes de 12 a 17 años deben presentar seropositividad para anticuerpos anti-AQP4 en la selección?.
    ? El resultado de la selección corresponde a los datos de la muestra de sangre recogida en la visita de selección o a los datos de la muestra de sangre recogida antes de la visita de selección y determinada por el laboratorio designado por el Promotor para el análisis (véase la sección
    2. Manifestaciones clínicas de al menos dos recidivas documentadas (incluido el primer episodio) en los 2 años anteriores a la selección, y que como mínimo una de ellas haya tenido lugar en los 12 meses anteriores a la selección.
    3. Puntuación de la escala EDSS (Expanded Disability Status Scale) de 0 a 6,5 (ambos extremos incluidos) en la selección.
    4. Edad de 12 a 74 años (ambos extremos incluidos) en el momento del consentimiento informado.
    5. Monoterapia con uno de los siguientes tratamientos basales para la prevención de las recidivas en dosis estables desde 8 semanas antes del momento basal **:
    a. Azatioprina.
    b. Micofenolato mofetilo.
    c. Corticosteroides orales.
    ** En los pacientes de 12 a 17 años se permite cualquiera de los siguientes tratamientos basales para la prevención de las recidivas:
    d. Azatioprina + corticosteroides orales.
    e. Micofenolato mofetilo + corticosteroides orales.
    6. Capacidad y voluntad de otorgar el consentimiento informado por escrito y cumplir los requisitos del protocolo.
    *Según Wingerchuk et al. 2006, el diagnóstico de NMO requiere los tres criterios siguientes:
    I. Neuritis óptica
    II. Mielitis aguda
    III. Al menos dos de los tres criterios complementarios:
    ? Lesión medular contigua de más de 3 segmentos vertebrales de extensión detectada mediante RMN
    ? RMN cerebral que no cumple los criterios diagnósticos de esclerosis múltiple
    ? Seropositividad para inmunoglobulina G de NMO
    E.4Principal exclusion criteria
    Exclusion criteria related to previous or concomitant therapy:
    1. Any previous treatment with interleukin-6 (IL-6) inhibitory therapy (e.g. tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time.
    2. Any previous treatment with anti-cluster of differentiation (CD) 20, eculizumab, belimumab, interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate within 6 months prior to baseline.
    3. Any previous treatment with anti-CD4, cladribine or mitoxantrone within 2 years prior to baseline.
    4. Treatment with any investigational agent within 3 months prior to baseline.
    Exclusions for general safety:
    5. Pregnancy or lactation.
    6. For patients of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier [patient or partner], in conjunction with a spermicidal product, contraceptive pill, patch, injectables, intrauterine device or intrauterine system) during the treatment period and for at least 3 months after the last dose of study drug.
    7. Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline.
    8. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML).
    9. Evidence of serious uncontrolled concomitant diseases that may preclude patient participation, such as: other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
    10. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.
    11. Evidence of chronic active hepatitis B or C.
    12. History of drug or alcohol abuse within 1 year prior to baseline.
    13. History of diverticulitis that, in the Investigator?s opinion, may lead to increased risk of complications such as lower gastrointestinal perforation.
    14. Evidence of active tuberculosis (TB; excluding patients receiving chemoprophylaxis for latent TB infection).
    15. Evidence of active interstitial lung disease.
    16. Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline.
    17. History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured).
    18. History of severe allergic reaction to a biologic agent (e.g. shock, anaphylactic reactions).
    19. Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening.
    Laboratory exclusion criteria (at screening):
    20. Following laboratory abnormalities at screening*.
    a. White blood cells <3.0 x103 /?L
    b. Absolute neutrophil count <2.0 x 103/?L
    c. Absolute lymphocyte count <0.5 x 103 /?L
    d. Platelet count <10 x 104/?L
    e. Aspartate aminotransferase or alanine aminotransferase >1.5 times the upper limit of normal.
    * If retest is conducted, the last value of retest before randomization must meet study criteria.
    Los pacientes que cumplan cualquiera de los criterios siguientes no podrán entrar en el estudio:
    Criterios de exclusión relacionados con el tratamiento previo o concomitante:
    1. Todo tratamiento previo con inhibidores de la interleucina 6 (IL-6; por ejemplo, tocilizumab), alemtuzumab, irradiación corporal total o trasplante de médula ósea en cualquier momento.
    2. Todo tratamiento previo con anti-CD20, eculizumab, belimumab, interferón, natalizumab, glatirámero acetato, fingolimod, teriflunomida o fumarato dimetilo en el plazo de los 6 meses anteriores al momento basal.
    3. Todo tratamiento previo con anti-CD4, cladribina o mitoxantrona en el plazo de los 2 años anteriores al momento basal.
    4. Tratamiento con cualquier producto en investigación en el plazo de los 3 meses anteriores al momento basal.
    Criterios de exclusión relacionados con la seguridad general:
    5. Embarazo o lactancia.
    6. En el caso de los pacientes potencialmente fértiles, resultado positivo en una prueba de embarazo en suero en la selección, o no estar dispuesto a utilizar métodos anticonceptivos fiables (método de barrera [paciente o pareja], junto con espermicida, anticonceptivo oral, en parche o inyectable, dispositivo intrauterino o sistema intrauterino) durante el periodo de tratamiento y como mínimo los 3 meses siguientes a la última dosis del fármaco del estudio.
    7. Intervención quirúrgica (excepto las intervenciones quirúrgicas menores) en el plazo de las 4 semanas anteriores al momento basal.
    8. Evidencia de otra enfermedad desmielinizante o leucoencefalopatía multifocal progresiva (LMP).
    9. Evidencia de enfermedades concomitantes graves no controladas que pudieran impedir la participación del paciente, como:
    otras enfermedades del sistema nervioso central, cardiovasculares, hematológicas/de la hematopoyesis, respiratorias, musculares, endocrinas, renales/urinarias, del aparato digestivo o inmunodeficiencia severa congénita o adquirida.
    10. Infección activa conocida (excluidas las infecciones fúngicas del lecho ungueal y la caries dental) en el plazo de las 4 semanas anteriores al momento basal.
    11. Evidencia de hepatitis B o C activa crónica.
    12. Antecedentes de alcoholismo o drogadicción en el plazo del año anterior al momento basal.
    13. Antecedentes de diverticulitis que, en opinión del Investigador, pudiera aumentar el riesgo de complicaciones, como perforación gastrointestinal inferior.
    14. Evidencia de tuberculosis (TB) activa (con exclusión de los pacientes tratados con quimioprofilaxis para TB latente).
    15. Evidencia de neumopatía intersticial activa.
    16. Recepción de vacunas de microorganismos vivos o microorganismos vivos atenuados en el plazo de las 6 semanas anteriores al momento basal
    17. Antecedentes de neoplasia maligna en los últimos 5 años, lo que incluye tumores sólidos, neoplasias hematológicas y carcinoma in situ (excepto carcinoma cutáneo basocelular o espinocelular, o carcinoma in situ del cuello uterino, tras resección completa y curación).
    18. Antecedentes de reacción alérgica severa a un producto biológico (por ejemplo, shock, reacción anafiláctica).
    19. Ideación suicida activa en el plazo de los 6 meses anteriores a la selección o antecedentes de intento de suicidio en el plazo de los 3 años anteriores a la selección.
    Criterios de exclusión relacionados con los análisis de laboratorio (en la selección):
    20. Las siguientes alteraciones de los análisis de laboratorio en la selección*.
    a. Leucocitos <3,0 × 103/?l
    b. Recuento absoluto de neutrófilos <2,0 × 103/?l
    c. Recuento absoluto de linfocitos <0,5 × 103/?l
    d. Recuento de plaquetas <10 × 104/?l
    e. Aspartato-aminotransferasa o alanina-aminotransferasa >1,5 veces el límite superior de la normalidad.
    * Si se repite la prueba, el último valor de la prueba antes de la aleatorización debe cumplir los criterios del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first protocol-defined relapse (TFR) in the double-blind period.
    Tiempo hasta la primera recidiva definida por el protocolo (TPR) en el periodo en doble ciego.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to first protocol-defined relapse (TFR) in the double-blind period.
    Tiempo hasta la primera recidiva definida por el protocolo (TPR) en el periodo en doble ciego.
    E.5.2Secondary end point(s)
    Secondary endpoints:
    i. Change in visual analogue scale (VAS) for pain
    ii. Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue
    iii. Change in Short Form generic health survey score (SF-36)
    iv. Change in EQ-5D
    v. The proportion of relapse-free patients
    vi. Annualized relapse rate (ARR)
    vii. Change in modified Rankin Scale (mRS)
    viii. Change in Zarit Burden Interview (ZBI)
    ix. Change in Expanded Disability Status Scale (EDSS)
    x. Change in visual acuity (Snellen chart)

    Pharmacodynamic endpoints:
    IL-6, soluble IL-6 receptor, high sensitivity C-reactive protein, anti-AQP4 antibodies and plasmablasts.

    Pharmacokinetic endpoints: serum SA237 concentrations

    Immunogenicity endpoints: Incidence of anti-SA237 antibodies

    Exploratory Endpoint: Additional pain assessment
    Criterios de valoración secundarios
    i. Variación de la puntuación de la escala analógica visual (EAV) de dolor
    ii. Variación de la puntuación de la escala FACIT (Functional Assessment of Chronic Illness Therapy) de fatiga
    iii. Variación de la puntuación de la escala SF-36 (Short Form Generic Health Survey)
    iv. Variación de la puntuación de la escala EQ-5D
    v. Porcentaje de pacientes sin recidiva
    vi. TAR
    vii. Variación de la puntuación de la escala de Rankin modificada (mRS)
    viii. Variación de la puntuación de la escala ZBI (Zarit Burden Interview)
    ix. Variación de la puntuación de la escala EDSS
    x. Variación de la agudeza visual (tabla optométrica)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Selected time points
    Momentos seleccionados
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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. 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    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
    Last Visit Last Subject
    Última Visita Ultimo Paciente
    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 years2
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    F.1.1Number of subjects for this age range: 8
    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) Yes
    F. of subjects for this age range: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 70
    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)
    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 Decision2015-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-09
    P. End of Trial
    P.End of Trial StatusOngoing
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