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    Summary
    EudraCT Number:2012-003632-23
    Sponsor's Protocol Code Number:NI-0501-04
    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:2013-02-15
    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 number2012-003632-23
    A.3Full title of the trial
    A Phase 2/3, Open-label, Single Arm, Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Multiple Administrations of NI-0501, an Anti-interferon Gamma (Anti-IFN Gamma) Monoclonal Antibody, in Paediatric Patients with Primary Haemophagocytic Lymphohistiocytosis (HLH)
    Estudio fase 2/3 multicéntrico, de brazo único, abierto, para evaluar la seguridad, tolerabilidad, farmacocinética y eficacia de administraciones múltiples intravenosas de NI-0501, un anticuerpo monoclonal anti-interferón gamma (Anti- IFN Gamma), en pacientes pediátricos con linfohistiocitosis hemofagocítica primaria (LHH).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the safety and efficacy of a new drug, NI-0501, in children with a disease that is called "Haemophagocytic Lymphohistiocytosis".
    Un estudio para investigar la seguridad y eficacia de un nuevo fármaco, NI-0501, en los niños con una enfermedad que se llama "Linfohistiocitosis hemofagocítico".
    A.4.1Sponsor's protocol code numberNI-0501-04
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01818492
    A.5.4Other Identifiers
    Name:US INDNumber:111015
    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 SponsorNovImmune SA
    B.1.3.4CountrySwitzerland
    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 supportNovImmune SA
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportSeventh Framework Programme for Research
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovImmune SA
    B.5.2Functional name of contact pointIsabelle Fournet
    B.5.3 Address:
    B.5.3.1Street Address14 Chemin des Aulx
    B.5.3.2Town/ cityPlan-les-Ouates
    B.5.3.3Post code1228
    B.5.3.4CountrySwitzerland
    B.5.5Fax number0041225938280
    B.5.6E-mailNI-0501.clinops@novimmune.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/749
    D.3 Description of the IMP
    D.3.1Product nameNI-0501
    D.3.2Product code NI-0501
    D.3.4Pharmaceutical form Concentrate 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 INNNI-0501
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNI-0501
    D.3.9.3Other descriptive nameHuman anti-interferon gamma 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 number5
    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 No
    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
    Haemophagocytic lymphohistiocytosis.
    Linfohistiocitosis hemofagocítica.
    E.1.1.1Medical condition in easily understood language
    A rare, life-threatening condition affecting predominantly children. The disease is characterized by uncontrolled hyper-inflammation on the basis of underlying immune deficiencies.
    Rara y potencialmente enfermedad mortal que afecta predominantemente a niños. La enfermedad se caracteriza por la incontrolada hiper- inflamación basándose en subyacente deficiencias inmunológicas
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level SOC
    E.1.2Classification code 10010331
    E.1.2Term Congenital, familial and genetic disorders
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 determine the safety and tolerability profile of multiple IV administrations of NI-0501
    To determine the efficacy and benefit/risk profile of NI-0501 in HLH patients
    To describe the pharmacokinetic (PK) profile of NI-0501 in HLH patients
    To determine the PD effects (levels of circulating Total IFNgamma and biomarkers of its neutralization namely CXCL9 and CXCL10)
    To define an appropriate NI-0501 therapeutic dose regimen for HLH
    TO determine other biomarkers, eg sCD25, IL-10
    To assess the immunogenicity of NI-0501
    Determinar la seguridad y el perfil de tolerabilidad de administraciones intravenosas (IV) múltiples de NI-0501
    Determinar la eficacia y el perfil riesgo/beneficio de NI-0501 en paciente LHH
    Describir el perfil PK de NI-0501 en pacientes LHH.
    Determinar los efectos FD (niveles totales de IFNgamma circulante y biomarcadores de su neutralización como CXCL9 y CXCL10)
    Definir un regimen de dosis terapeutica de NI-0501 adecuado para HLH
    Determinar otro bio marcadores, ej: SCD25, IL-10
    Evaluar la inmunogenicidad de NI-0501.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Primary HLH patients of both genders, up to and including 18 years at diagnosis of HLH. The diagnosis of HLH must be made on the basis of the following criteria (as per HLH-2004 protocol):
    a. A molecular diagnosis or familial history consistent with primary HLH
    OR
    b. Five out of the eight criteria below are fulfilled:
    - Fever
    - Splenomegaly
    - Cytopenias affecting 2 of 3 lineages in the peripheral blood (hemoglobin < 90 g/L; platelets < 100 x 109/L; neutrophils < 1 x 109/L)
    - Hypertriglyceridemia (fasting triglycerides > 3 mmol/L or > 265 mg/dL) and/or hypofibrinogenemia (<= 1.5 g/L)
    - Hemophagocytosis in bone marrow, spleen or lymph nodes, with no evidence of malignancy
    - Low or absent natural killer (NK)-cell activity
    - Ferritin >= 500 microg/L
    - Soluble CD25 (sCD25; i.e. soluble IL-2 receptor) >= 2400 U/mL.
    2. Presence of active disease in patients as assessed by the treating physician.
    3. Patients having already received HLH conventional therapy must fulfill one of the following criteria as assessed by the treating physician :
    - Having not responded
    - Having not achieved a satisfactory response
    - Having not maintained a satisfactory response
    - Showing intolerance to conventional treatment of HLH
    At the time of enrollment, eligible patients might still be receiving treatment (induction or maintenance) or might have already discontinued it.
    4. Informed consent signed by the patient (if ? 18 years old), or by the patient?s legally authorized representative(s) with the assent of patients who are legally capable of providing it.
    5. Having received guidance on contraception for both male and female patients sexually active and having reached puberty:
    Females of child-bearing potential, having a negative pregnancy test at screening, and unless true abstinence is in line with the preferred and usual lifestyle of the patient, must agree to use adequate method(s) of birth control from screening until 6 months after receiving last dose of the study drug. Males with partners(s) of child-bearing potential must agree to take appropriate precautions to avoid fathering a child from screening until 6 months after receiving last dose of the study drug.
    1. Pacientes con LHH primaria de ambos sexos, hasta e incluyendo los 18 años de edad en el momento del diagnóstico de LHH. El diagnóstico de LHH debe realizarse de acuerdo con los siguientes criterios (conforme al protocolo HLH-2004):
    a. Un diagnóstico molecular o antecedentes familiares consistentes con LHH primaria
    O
    b. Deben cumplirse cinco de los ocho criterios de abajo:
    - Fiebre
    - Esplenomegalia
    - Citopenias que afecten a 2 de las 3 líneas en la sangre periférica (hemoglobina < 90 g/L; plaquetas < 100 x 109/L; neutrófilos < 1 x 109/L)
    - Hipertrigliceridemia (triglicéridos en ayunas > 3 mmol/L o > 265 mg/dL) y/o hipofibrinogenemia (<= 1,5 g/L)
    - Hemofagocitosis en la médula ósea, bazo o nódulos linfáticos, sin evidencia de malignidad
    - Ausencia o baja actividad de las células NK
    - Ferritina >= 500 microg/L
    - CD25 soluble (sCD25; es decir, receptor IL-2 soluble) >= 2400 U/mL
    2. Presencia de enfermedad activa en pacientes según el criterio del médico responsable.
    3. Los pacientes que ya hayan recibido una terapia convencional para la LHH deben cumplir uno de los siguientes criterios según la valoración del médico responsable del tratamiento :
    - No haber mostrado ninguna respuesta.
    - No haber logrado una respuesta satisfactoria.
    - No haber mantenido una respuesta satisfactoria.
    Presentar intolerancia al tratamiento convencional de la LHH.
    En el momento de la inclusión en el estudio, los pacientes elegibles pueden estar todavía recibiendo tratamiento (inducción o mantenimiento) o pueden haberlo abandonado ya.
    4. Consentimiento informado firmado por el paciente (si ? 18 años) o por los representantes legalmente autorizados del paciente con la conformidad de pacientes que son legalmente capaces de proporcionarla.
    5. En el caso de los pacientes, de ambos sexos, sexualmente activos y que han alcanzado la pubertad, se les ha informado acerca de las medidas anticonceptivas necesarias:
    Las mujeres potencialmente fértiles, tras una prueba de embarazo negativa en la selección y, salvo si la abstinencia real fuera su método anticonceptivo preferido y habitual, deberán mostrar su conformidad en utilizar dos métodos anticonceptivos adecuados desde la selección hasta 6 meses después del tratamiento con el medicamento del estudio.
    Los hombres con pareja o parejas potencialmente fértiles deberán mostrar su conformidad en utilizar las precauciones adecuadas para no engendrar un hijo desde la selección hasta 6 meses después del tratamiento con el medicamento del estudio
    E.4Principal exclusion criteria
    1. Diagnosis of secondary HLH consequent to a proven rheumatic or neoplastic disease.
    2. Body weight < 3 kg.
    3. Patients treated with:
    any T-cell depleting agents (such as anti-thymocyte globulin [ATG], anti-CD52) during the previous 2 weeks prior to screening
    any other biologic drug within 5 times their defined half-life period, except for rituximab in case of documented B-cell EBV infection (a list of some of the most commonly used biologic half-lives will be included in the Study Specific Risk Management Plan)
    4. Active mycobacteria, Shigella, Histoplasma capsulatum, Campylobacter, Leishmania or Salmonella infections.
    5. Evidence of history of tuberculosis or of latent tuberculosis.
    6. Positive serology for HIV antibodies, hepatitis B surface antigen or hepatitis C antibodies.
    7. Presence of malignancy.
    8. Patients who have another concomitant disease or malformation severely affecting cardiovascular, pulmonary, liver or renal function.
    9. History of hypersensitivity or allergy to any component of the study regimen.
    10. Receipt of a live or attenuated live (including BCG) vaccine within the previous 12 weeks prior to screening.
    11. Pregnant or lactating female patients
    1. Diagnóstico de LHH secundaria consiguiente a una enfermedad neoplástica o reumática probada.
    2. Peso corporal < 3 kg.
    3. Pacientes tratados con:
    cualquier agente de debilitamiento de las células T (como globulina antitimocito[ATG], anti-CD52) durante las dos semanas precedentes antes de la selección
    cualquier otro fármaco biológico dentro de 5 veces su periodo de semivida definido, excepto por rituximab en el caso de infección documentada por EBV Celulas B (en el Plan de Gestión de Riesgos Específico para el Estudio se encuentra un listado de las semividas de los agentes biológicos de empleo más frecuente)
    4. Micobacterias activas, shigelosis, infecciones por Histoplasma capsulatum, Campylobacter, leishmaniosis o infecciones de salmonelosis.
    5. Evidencia de antecedentes de tuberculosis o latente.
    6. Serología positiva para anticuerpos VIH, antígeno de superficie de hepatitis B o anticuerpos de hepatitis C.
    7. Historia de malignidad.
    8. Pacientes que tengan otra enfermedad concomitante o malformación que afecte severamente las funciones cardiovasculares, pulmonares, del hígado o renales.
    9. Historia de hipersensibilidad o alergia a cualquier componente del régimen de estudio.
    10. Recepción de una vacuna viva o vacuna viva atenuada (incluyendo BCG) dentro de las 12 semanas anteriores a la selección (screening)
    11 . Mujeres embarazadas o en lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endopoint
    Overall response rate, ie: achievement of either Complete or Partial Response or HLH improvement, at End of treatment (EoT)
    Principal variable
    Tasa de respuesta Global, ej: alcanzar o Respuesta completa o parcial o mejora de HLH, en la visita de Final de Tratamiento (EoT).
    E.5.1.1Timepoint(s) of evaluation of this end point
    See E.5.1.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    •Time to Response any time during the study
    •Durability of Response, i.e. maintenance of response achieved any time
    during the study until EoT and beyond (including data collected in the
    long-term follow-up study NI-0501-05).
    •Number of patients able to reduce glucocorticoids by 50% or more of
    baseline dose.
    •Number of patients able to proceed to HSCT, when deemed indicated.
    •Survival at Week 8 (or EoT) and at the end of the study Long-term
    survival (in particular D+30 and D+100 post-HSCT survival) will be
    assessed in the context of long-term study NI-0501-05.
    •Serum concentration of NI-0501 to determine NI-0501 pharmacokinetic
    (PK) profile.
    •Determination of pharmacodynamic (PD) effects (levels of circulating
    total IFNγ and markers of its neutralization, namely CXCL9 and CXCL10).
    •Determination of other biomarkers, e.g. sCD25, IL-10.

    Safety parameters to be collected and assessed:
    - Incidence, severity, causality and outcomes of Adverse Events (serious
    and non-serious), with particular attention being paid to infections
    - Number of patients withdrawn for safety reasons
    Other parameters:
    - Level (if any) of circulating antibodies against NI-0501 to determine
    immunogenicity (ADA).
    Variables de eficacia secundaria:
    •Tiempo hasta respuesta en cualquier momento del estudio.
    •Duración de la respuesta, ej: mantenimiento de la respuesta alcanzada en cualquier momento durante el estudio hasta la EOT y posterior(incluyendo datos recogidos en el estudio de seguimiento a largo plazo).
    •Número de pacientes capaces de reducir los glucorticoides al 50% o más de la dosis basal
    •Número de pacientes capaces de proceder con HSCT, cuando se considere necesario.
    •Superviviencia en las semana 8 (o EoT) y al final del estudio.
    Se evaluará en el contexto del estudio de largo plazoNI-0501-05 la sUpervivencia a largo plazo (en particular D+30 y D+100 supervivencia post-HSCT )
    •Concentración en suero de NI-0501 para determinae el pérfil farmacocinético (FC)de NI-0501 .
    •Determinación de los efectos farmacodinámicos (niveles de IFNγ total circulante y marcadores de su neutralización, como CXCL9 and CXCL10).
    •Determinacion de otros biomarcadores e.j. sCD25, IL-10.

    Párametros de seguridad a recoger y evaluar:
    - Incidencia, severidad, causalidad y resolución de eventos adversos(serios y no serios), teniendo especial antención con las infecciones
    - Número de pacientes retirados por razones de seguridad
    Otros parámetros:
    - Nivel (si hay) de anticuerpos circulantes contra NI-0501 para determinar la inmunogenicidad. (ADA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA14
    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
    Austria
    Germany
    Italy
    Spain
    Sweden
    Turkey
    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 years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 38
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 3
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 20
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 8
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 3
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Newborns, infants and toddlers
    Neonatos, lactantes y niños
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 38
    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)
    After study end, a separate long term follow-up study will be initiated to allow long term safety surveillance, investigation of the impact of NI-0501 treatment on survival and post-HSCT outcome measures for all patients who will have received at least one dose of NI-0501.
    Después del fin del estudio, se iniciará un estudio separado de seguimiento a largo plazo, para permitir la revisión de la supervivencia a largo plazo, investigación del impacto del tratamiento con NI-0501 en la supervivencia y en los resultados de las medidas post-HSCT para todos los pacientes que hayan recibido al menos una dosis de NI-0501.
    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 Decision2013-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-01-04
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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