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    Summary
    EudraCT Number:2012-000725-41
    Sponsor's Protocol Code Number:CLI-107-15
    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:2012-09-14
    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 number2012-000725-41
    A.3Full title of the trial
    A randomized, placebo controlled, multicenter phase IIb study of human recombinant Interleukin-7 (CYT107) in HIV-related Progressive Multifocal Leukoencephalopathy.
    Ensayo clínico aleatorio controlado por placebo y multicéntrico de fase IIb de interleucina-7 recombinante humana (CYT107) en pacientes infectados con VIH que han desarrollado leucoencefalopatía multifocal progresiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, placebo controlled, multicenter phase IIb study of human recombinant Interleukin-7 (CYT107) in HIV-related Progressive Multifocal Leukoencephalopathy
    Ensayo clínico aleatorio controlado por placebo y multicéntrico de fase IIb de interleucina-7 recombinante humana (CYT107) en pacientes infectados con VIH que han desarrollado leucoencefalopatía multifocal progresiva
    A.3.2Name or abbreviated title of the trial where available
    INVICTUS
    INVICTUS
    A.4.1Sponsor's protocol code numberCLI-107-15
    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 SponsorCytheris S.A.
    B.1.3.4CountryFrance
    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 supportCytheris S.A.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCytheris S.A.
    B.5.2Functional name of contact pointCytheris Information
    B.5.3 Address:
    B.5.3.1Street Address175 rue Jean-Jacques Rousseau
    B.5.3.2Town/ cityIssy les Moulineaux, Cedex
    B.5.3.3Post code92138
    B.5.3.4CountryFrance
    B.5.4Telephone number+33158 88 38 00
    B.5.5Fax number+33146 44 44 46
    B.5.6E-mailinfo@cytheris.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 numberEMA/OD/011/12
    D.3 Description of the IMP
    D.3.1Product nameRecombinant human interleukin-7
    D.3.2Product code CYT107
    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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeCYT107
    D.3.9.3Other descriptive nameRecombinant human interleukin-7
    D.3.9.4EV Substance CodeN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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
    HIV-infected patients with Progressive Multifocal Leukoencephalopathy
    Pacientes infectados con VIH que han desarrollado leucoencefalopatía multifocal progresiva
    E.1.1.1Medical condition in easily understood language
    HIV-infected patients with Progressive Multifocal Leukoencephalopathy
    Pacientes infectados con VIH que han desarrollado leucoencefalopatía multifocal progresiva
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10036807
    E.1.2Term Progressive multifocal leukoencephalopathy
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to assess CYT107 efficacy on JCV clearance from cerebrospinal fluid.
    El objetivo principal de este estudio es evaluar la eficacia del CYT107 en la eliminación del virus John Cunningham (JC) del líquido cefalorraquídeo (LCR)
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    o to assess the clinical safety of CYT107
    o to assess the effect on patient survival
    o to measure the effect on neurological and clinical status
    o to assess the biological activity of CYT107:
    - on the kinetics of JCV reduction in CSF
    - on the main parameters of the immune reconstitution
    - on the specific T-cell response against the JC virus
    Los objetivos secundarios son:
    ? evaluar la seguridad clínica del CYT107
    ? evaluar el efecto en la supervivencia del paciente
    ? medir el efecto en el estado clínico y neurológico
    ? evaluar la actividad biológica de la CYT107:
    o en la cinética del cambio de carga del virus JC en el líquido cefalorraquídeo
    o en los parámetros principales de la reconstitución inmune
    o en la respuesta específica de los linfocitos T frente al virus JC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ?18 years.
    2. HIV-1 infection.
    3. Neurological findings compatible with the development of active PML, established by criteria defined in protocol
    4. Patients have to be on effective cART after PML diagnosis, for at least 4 weeks.
    5. HIV RNA load in blood <1000 copies/mL.
    6. Karnofsky Performance Status, score ? 30%.
    7. Patient with medical insurance or government support.
    8. Ability of the patient (or a legal representative if decision making capacity is impaired) to understand and sign informed consent.
    1. Edad ?18 años.
    2. Infección por VIH-1.
    3. Resultados neurológicos compatibles con el desarrollo de la leucoencefalopatía multifocal progresiva activa (LMP), según los criterios establecidos en el protocolo.
    4. Después de haber sido diagnosticada la leucoencefalopatía multifocal progresiva, los pacientes tienen que llevar como mínimo 4 semanas en terapia antirretroviral efectiva combinada.
    5. Carga en sangre de ARN del virus VIH <1.000 copias/mL.
    6. Nivel funcional de Karnofsky, puntuación ? 30.
    7. Paciente con seguro médico o ayuda estatal.
    8. Capacidad del paciente (o del representante legal en caso de deficiencia del paciente para tomar decisiones) de entender y firmar el consentimiento informado.
    E.4Principal exclusion criteria
    1. Pregnancy or breast feeding.
    2. Refusal or inability to practice contraception regardless of the gender of the patient.
    3. MRI documented PML-IRIS.
    4. Prior treatment with interleukin-7.
    5. Hepatitis B surface antigen (HBsAg) positive.
    6. ALT and/or AST > 5 x ULN.
    7. Use of another investigational or interventional treatment within the last 3 months prior to study entry.
    8. Any current malignancy except Kaposi Sarcoma that does not require chemotherapy.
    9. Current opportunistic CNS infection.
    10. Active tuberculosis.
    11. Other current severe illness or other conditions (such as autoimmune disease, severe mental illness) that, in the opinion of the investigator, would make the subject unsuitable for enrollment.
    1. Embarazo y lactancia.
    2. Rechazo y/o imposibilidad de utilizar una contracepción independientemente del sexo del paciente.
    3. Síndrome inflamatorio de reconstitución inmunitaria asociado a la leucoencefalopatía multifocal progresiva (LMP-SIRI) documentado por resonancia magnética.
    4. Tratamiento previo con interleucina-7.
    5. Antígeno de superfície de Hepatitis B (HbsAg) positivo.
    6. Alanina transaminasa (ALT) y/o Aspartato transaminasa (ASAT) > 5 x como límite superior.
    7. Uso de otros tratamientos de investigación o cualquier intervención realizada durante los 3 meses anteriores a la incorporación al ensayo.
    8. Cualquier afección maligna, excepto el sarcoma de Kaposi, que no requiera quimioterapia.
    9. Presencia de otra infección oportunista del sistema nervioso central (SNC).
    10. Tuberculosis activa.
    11. Presencia de otra enfermedad grave (enfermedad autoinmune, enfermedad mental grave) u otra condición que, en opinión del investigador, haría que el sujeto no fuese apto para su reclutamiento.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is defined as the clearance of the JCV from the CSF at M3.
    El parámetro de eficacia principal será el porcentaje de pacientes que eliminen el virus JC del LCR en 3 meses.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be assessed at 3 months.
    El parámetro de eficacia principal será evaluado despues de 3 meses.
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    ? Kinetics of the JC viral load changes
    ? ?Survival? curves for time to JCV viral clearance in CSF
    ? MRI lesions changes
    ? Percentage change in neurological scores
    ? Change in Karnofsky Performance Status;
    ? MRS scores
    ? Proportion of patients with a MRS score < 3
    ? Changes in CD4+ and CD8+ T-cell subsets
    ? Changes of specific T-cell responses, proliferation indices, JCV-specific T-cell responses
    ? Survival rate
    Los parámetros secundarios serán los siguientes:
    ? Se analizará la cinética del cambio de carga del virus JC en el líquido cefalorraquídeo
    ? El tiempo necesario para eliminar el virus en el liquido cefalorraquideo
    ? Cambios en lesiones IRM
    ? Evaluación neurológica
    ? Cambios en los resultados MRS
    ? Cambios en los contajes totales de células CD4, CD8
    ? Cambios en las respuestas especificas de las celulas T, indices de proliferaction y respuestas especificas de las celulas T contra el JCV
    ? Estado de sobreviviencia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints of evaluation of secondary endpoints are as follows:
    ? Kinetics of the JCV viral load changes from D0 to M3
    ? Kinetics of the JCV viral load changes from D0 to M12
    ? ?Survival? curves for time to JCV viral clearance in CSF
    ? Percentage change in neurological scores between baseline and M12
    ? Change in Karnofsky Performance Status between D0 and M12;
    ? MRS scores at M12
    ? Survival rate at M12
    ? Cinética del cambio de carga del virus JC en el líquido cefalorraquídeo del D0 al M3 y del D0 al M12
    ? El tiempo necesario para eliminar el virus en el liquido cefalorraquideo
    ? Evaluación neurológica desde el inicio hasta el M12
    ? Cambios en los resultados MRS desde el inicio hasta el M12
    ? Estado de sobreviviencia en el M12
    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 No
    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.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 Yes
    E.8.1.4Double blind No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    European Union
    Switzerland
    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 patient last visit date.
    Ultima visita del 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 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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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
    Consent can be given by a legal representative if the subject's decision making capacity is impaired.
    Un representante legal puede consentir al estudio si el paciente es incapaz de tomar decisiones.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 57
    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 Decision2012-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-27
    P. End of Trial
    P.End of Trial StatusOngoing
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