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    Summary
    EudraCT Number:2017-001418-27
    Sponsor's Protocol Code Number:20150168
    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:2017-07-31
    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 number2017-001418-27
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
    Estudio de fase III, aleatorizado, doble ciego y controlado con principio activo para evaluar la eficacia y la seguridad de ABP 959 en comparación con eculizumab en sujetos adultos con hemoglobinuria paroxística nocturna (HPN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on the
    investigational medicine after you have been given it, and if this is
    comparable to what is seen for the licensed medicine, eculizumab, in
    patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).
    This study will assess if the investigational medicine is safe and effective in
    treating PNH compared to the licensed medicine.
    Este enayo está diseñado para determinar los efectos que el medicamento investigado, ABP 959, tiene sobre el cuerpo humano y que efectos tiene el cuerpo sobre la medicación investigada una vez administrada, y si estos son comparables con los vistos para la medicina comercializada, eculizumab, en pacientes con hemoglobinuria paroxística nocturna (HPN).
    Este estudio evaluará si el medicamento investigado es seguro y efectivo en el tratamiento de la HPN comparado con la medicación comercializada.
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    No aplica
    A.4.1Sponsor's protocol code number20150168
    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 SponsorAmgen 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstr. 23, PO Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post code6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfointernational@amgen.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 nameABP 959
    D.3.2Product code ABP 959
    D.3.4Pharmaceutical form 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 INNECULIZUMAB
    D.3.9.1CAS number 219685-50-4
    D.3.9.2Current sponsor codeABP 959
    D.3.9.3Other descriptive nameABP 959 - biosimilar to eculizumab
    D.3.9.4EV Substance CodeSUB25187
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number900
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Soliris
    D.2.1.1.2Name of the Marketing Authorisation holderAlexion Pharmaceuticals Inc.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSoliris
    D.3.4Pharmaceutical form 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 INNECULIZUMAB
    D.3.9.1CAS number 219685-50-4
    D.3.9.4EV Substance CodeSUB25187
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number900
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Hemoglobinuria paroxística nocturna (HPN)
    E.1.1.1Medical condition in easily understood language
    Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Hemoglobinuria paroxística nocturna (HPN)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective for this study is to evaluate the efficacy of ABP 959 compared with that of eculizumab based on control of intravascular hemolysis.
    El objetivo principal de este estudio es evaluar la eficacia de ABP 959 en comparación con la de eculizumab en base al control de la hemólisis intravascular.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the safety, pharmacokinetics (PK),
    and immunogenicity of ABP 959 compared with that of eculizumab.
    El objetivo secundario es evaluar la seguridad, la farmacocinética (FC) y la inmunogenia de ABP 959 en comparación con las de eculizumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The study will enroll subjects with PNH who are stable on eculizumab treatment. Subjects cannot be enrolled or randomized before all inclusion criteria (including test results) are confirmed:
    1. Men and women ≥ 18 years of age
    2. Confirmed diagnosis of PNH by documented flow cytometry
    3. Administration of eculizumab for ≥ 6 months and currently receiving 900 mg of eculizumab every 14 ± 2 days
    4. Hemoglobin ≥ 9.0 g/dL for at least 6 weeks prior to randomization
    5. Lactate dehydrogenase (LDH) < 1.5 × the upper limit of normal at screening
    6. Platelet count ≥ 50 × 10^9/L
    7. Absolute neutrophil count > 0.5 x 10^9/L (500/μL)
    8. Subjects must be vaccinated against Neisseria meningitidis. Subjects must be vaccinated or revaccinated according to current national guidelines for vaccination use.
    9. Subjects must sign an institutional review board/independent ethics committee-approved informed consent form before participation in any procedures.
    El estudio incluirá sujetos con HPN con un tratamiento estable con eculizumab. No se podrá incluir o aleatorizar a los sujetos antes de que se hayan confirmado todos los criterios de inclusión (incluidos los resultados de las pruebas):
    1. Hombres y mujeres con ≥ 18 años de edad
    2. Diagnóstico confirmado de HPN mediante citometría de flujo documentada
    3. Administración de eculizumab durante ≥ 6 meses y que actualmente reciban 900 mg de eculizumab cada 14 ± 2 días
    4. Hemoglobina ≥ 9,0 g/dl durante al menos 6 semanas antes de la aleatorización
    5. Lactato-deshidrogenasa (LDH) < 1,5 × el límite superior de la normalidad en la selección.
    6. Recuento de plaquetas ≥ 50 × 10^9/l
    7. Recuento absoluto de neutrófilos > 0,5 x 10^9/l (500/μl)
    8. Los sujetos deben estar vacunados contra la Neisseria meningitidis. Los sujetos deben estar vacunados o revacunados de acuerdo con las directrices nacionales vigentes de uso de vacunas.
    9. Los sujetos deben firmar un formulario de consentimiento informado aprobado por la junta de revisión institucional o el comité de ética independiente antes de la participación en cualquier procedimiento.
    E.4Principal exclusion criteria
    If any of the following apply, the subject MUST NOT enter the study:
    1. Known or suspected hereditary complement deficiency
    2. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure [New York Heart Association ≥ Class III], serious uncontrolled cardiac arrhythmia), peripheral vascular disease, cerebrovascular accident, or transient ischemic attack in the previous 6 months
    3. Evidence of acute thrombosis (liver Doppler ultrasound of hepatic and portal veins)
    4. Known to be positive for human immunodeficiency virus
    5. Woman who is pregnant or breastfeeding
    6. Woman of childbearing potential who does not consent to use a highly effective method of birth control (e.g., true abstinence, sterilization, birth control pills, Depo Provera injections, or contraceptive implants) during treatment and for an additional 5 months after the last administration of protocol-specified treatment
    7. Man with a partner of childbearing potential who does not consent to use a highly effective method of birth control (eg, true abstinence, vasectomy, or a condom in combination with hormonal birth control or barrier methods used by the woman) during treatment and for an additional 5 months after the last administration of protocol-specified treatment
    8. Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s).
    9. Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell-derived drug products.
    10. History or evidence of clinically significant disorder, infection, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
    Si se da alguna de las siguientes situaciones, el sujeto NO DEBE participar en el estudio:
    1. Deficiencia del complemento hereditaria conocida o sospechada
    2. Enfermedad cardiovascular clínicamente significativa (lo que incluye infarto de miocardio, angina inestable, insuficiencia cardíaca congestiva sintomática [Asociación del Corazón de Nueva York ≥ Clase III], arritmia cardíaca grave no controlada), enfermedad vascular periférica, accidente cerebrovascular o accidente isquémico transitorio en los 6 meses anteriores
    3. Evidencias de trombosis aguda (ecografía Doppler hepática de venas hepáticas y portales)
    4. Infección por el virus de la inmunodeficiencia humana positiva
    5. Mujer embarazada o amamantando
    6. Mujer con capacidad de concebir que no acepte utilizar un método de regulación de la natalidad de alta eficacia (p. ej., abstinencia verdadera, esterilización, píldoras para la regulación de la natalidad, inyecciones de Depo-Provera o implantes anticonceptivos) durante el tratamiento y durante 5 meses adicionales después de la última administración del tratamiento especificado en el protocolo
    7. Hombre con una pareja con capacidad de concebir que no acepte utilizar un método de regulación de la natalidad de alta eficacia (p. ej., abstinencia verdadera, vasectomía o un preservativo en combinación con métodos de regulación de la natalidad hormonales o de barrera utilizados por la mujer) durante el tratamiento y durante 5 meses adicionales después de la última administración del tratamiento especificado en el protocolo
    8. El sujeto está incluido actualmente en otro estudio de un dispositivo o fármaco en fase de investigación o todavía no han transcurrido al menos 30 días desde la finalización del mismo, o el sujeto está recibiendo otros agentes en fase de investigación
    9. Sujeto que tenga sensibilidad conocida a cualquiera de los productos que se administrarán durante el estudio, incluidos productos farmacológicos derivados de células mamarias
    10. Antecedentes o evidencia de trastorno, infección, afección o enfermedad clínicamente significativos que, en opinión del investigador o médico de Amgen, si es consultado, pondría en riesgo la seguridad del sujeto o interferiría con la evaluación, procedimientos o finalización del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint for Parallel Comparison:
    • Hemolysis, as measured by LDH at week 27
    Primary Endpoint for Crossover Comparison:
    • Hemolysis, as measured by the time-adjusted AUEC of LDH from week 39 to 53 and from week 65 to 79
    Criterio de valoración principal para la comparación con grupos paralelos:
    • Hemólisis, medida mediante la LDH en la semana 27
    Criterio de valoración principal para la comparación con grupos cruzados:
    • Hemólisis, medida mediante el AUEC ajustada por el tiempo de LDH desde la semana 39 a la 53 y desde la semana 65 a la 79
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of the primary endpoint of week 27 LDH for the parallel comparison will be conducted on the Full Analysis Set (FAS), consisting of all randomized subjects, with treatment as randomized in Period 1 regardless of treatment actually received.
    The primary analysis of the primary endpoint of time-adjusted AUEC of LDH for the crossover comparison will be conducted on the Modified Full Analysis Set (mFAS), consisting of all randomized subjects who have an LDH-time profile evaluable for the time-adjusted AUEC within weeks 39 to 53 and/or within weeks 65 to 79, according to treatment per the randomized sequence regardless of treatment actually received.
    El análisis principal del criterio de valoración principal de la LDH de la semana 27 para los grupos paralelos se realizará en el conjunto de análisis completo (Full Analysis Set, FAS), que consta de todos los sujetos aleatorizados, con tratamiento como aleatorizado en el período 1, independientemente del tratamiento real recibido.
    El análisis principal del criterio de valoración principal del AUEC ajustada por tiempo de LDH para la comparación cruzada se realizará en el conjunto de análisis completo modificado, que consta de todos los sujetos aleatorizados con un perfil de tiempo de LDH evaluable para el AUEC ajustada por tiempo de las semanas 39 a la 53 y/o 65 a la 79, de acuerdo al tratamiento conforme a la secuencia aleatorizada, independientemente del tratamiento real recibido.
    E.5.2Secondary end point(s)
    • Total complement (CH50), total hemoglobin, serum-free hemoglobin, haptoglobin, bilirubin, degree of hemoglobinuria, and type III erythrocytes at week 27, week 39, week 53, and post-crossover week 65 and week 79
    • LDH-time profile
    • Red blood cell transfusion
    • Pharmacokinetic area under the curve (AUC) of ABP 959 and eculizumab from week 13 to 15, and trough PK
    • Complemento total (CH50), hemoglobina total, hemoglobina libre en suero, haptoglobina, bilirrubina, grado de hemoglobinuria y eritrocitos tipo III en la semana 27, la semana 39, la semana 53, y las semanas 65 y 79 posteriores al cruce
    • Perfil de tiempo de LDH
    • Transfusión de glóbulos rojos
    • Área bajo la curva (ABC) farmacocinética de ABP 959 y eculizumab desde la semana 13 a la 15 y FC mínima
    E.5.2.1Timepoint(s) of evaluation of this end point
    The analysis of secondary endpoints (except for PK) will be conducted on the FAS. Total complement, total hemoglobin, serum-free hemoglobin, haptoglobin, bilirubin, degree of hemoglobinuria, and type III erythrocytes (%) at weeks 27, 39, 53, 65, and 79 will be summarized descriptively. For the endpoint of red blood cell transfusions, summary statistics for the number of packed red cells transfused per month after week 13 will be presented. A descriptive summary of LDH at each time point through the end of the study will be presented. Individual and mean LDH-time profile during the study will also be presented graphically.
    El análisis de los criterios de valoración secundarios (excepto para FC) se realizará en el FAS. El complemento total, la hemoglobina total, la hemoglobina libre en suero, la haptoglobina, la bilirrubina, el grado de hemoglobinuria y los eritrocitos tipo III (%) en la semana 27, 39, 53, 65 y 79 se resumirán descriptivamente. Para el criterio de valoración de las transfusiones de glóbulos rojos, se presentarán los datos estadísticos resumidos del número de glóbulos rojos concentrados transfundidos al mes después de la semana 13. Se presentará un resumen descriptivo de la LDH en cada punto temporal hasta el final del estudio. También se presentará gráficamente el perfil individual y de tiempo de LDH medio durante el estudio.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Anti-drug Antibody testing
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 EEA16
    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
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Russian Federation
    Spain
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months6
    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 months6
    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: 35
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 40
    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 Decision2017-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-21
    P. End of Trial
    P.End of Trial StatusOngoing
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