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    Summary
    EudraCT Number:2012-000725-41
    Sponsor's Protocol Code Number:CLI-107-15
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-12-11
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio multicentrico, controllato con placebo, randomizzato, di fase IIb, sul trattamento con interleuchina-7 umana ricombinante (CYT107) in pazienti con infezione da HIV affetti da leucoencefalopatia multifocale progressiva
    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
    Studio multicentrico, controllato con placebo, randomizzato, di fase IIb, sul trattamento con interleuchina-7 umana ricombinante (CYT107) in pazienti con infezione da HIV affetti da leucoencefalopatia multifocale progressiva
    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
    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
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCytheris
    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+33 1 58 88 38 00
    B.5.5Fax number+33 1 46 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 numberEU/3/12/1013
    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.3.9.3Other descriptive nameRecombinant human interleukin-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    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
    Pazienti con infezione da HIV affetti da leucoencefalopatia multifocale progressiva
    E.1.1.1Medical condition in easily understood language
    HIV-infected patients with Progressive Multifocal Leukoencephalopathy
    Pazienti con infezione da HIV affetti da leucoencefalopatia multifocale progressiva
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    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.
    Valutare l'efficacia di CYT107 sulla eliminazione del JCV (virus John Cunningham) dal liquido cerebrospinale (LCS)
    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
    · valutare la sicurezza clinica di CYT107 · valutare l'effetto sulla sopravvivenza del paziente · misurare l'effetto sullo stato neurologico e clinico · valutare l'attività biologica di CYT107: o sulla cinetica delle variazioni della carica virale JCV nell'LCS o sui principali parametri della ricostituzione immunitaria o sulla risposta delle cellule T specifiche contro il JCV
    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 (Progressive Multifocal Leukoencephalopathy), established by the following criteria: a) Occurrence of new symptoms or worsening of pre-existing symptoms b) Detection of JCV DNA in CSF by qualitative PCR (Polymerase Chain Reaction) c) MRI (Magnetic Resonance Imaging) documented focal cerebral lesions in relation with symptoms d) No other likely cause according to investigator opinion 4. Patients have to be on effective cART after PML diagnosis for at least 4 weeks Note: effective cART is defined as a combination of marketed ARV (anti-retroviral) treatments according to national recommendations. 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. Età ≥ 18 anni. 2. Infezione da HIV-1. 3. Risultanze neurologiche compatibili con lo sviluppo di PML (leucoencefalopatia multifocale progressiva) attiva, stabilite in base ai seguenti criteri: a) Comparsa di nuovi sintomi o peggioramento di sintomi preesistenti b) Rilevazione del DNA di JCV nell'LCS mediante PCR (reazione a catena della polimerasi) qualitativa c) Lesioni cerebrali focali documentate tramite risonanza magnetica (RMN) in relazione con i sintomi d) Nessun altra causa probabile secondo lo sperimentatore 4. I pazienti devono essere in trattamento efficace con cART dopo la diagnosi della PML da almeno 4 settimane Nota: il trattamento efficace con cART è definito come una combinazione di trattamenti antiretrovirali (ARV) commercializzati in conformità alle raccomandazioni nazionali. 5. Carica virale di HIV-RNA nel sangue &lt;1000 copie/mL. 6. Scala di Karnofsky, punteggio ≥ 30. 7. Paziente in possesso di assicurazione sanitaria o che beneficia dell'assistenza sanitaria pubblica. 8. Abilità del paziente (o del legale rappresentante se il paziente è incapace di decidere) di capire e firmare un modulo di consenso informato.
    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 (Immune Reconstitution Inflammatory Syndrome)
    4. Prior treatment with interleukin-7.
    5. Hepatitis B surface Antigen (HbsAg) positive
    6. ALT and/or AST > 5 x ULN.
    7. Use of other investigational or any interventional treatments, within the last 3
    months prior to study entry.
    8. Any current malignancy except Kaposi Sarcoma that does not require
    chemotherapy.
    9. Other current opportunistic CNS (Central Nervous System) 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 enrolment.
    1. Gravidanza o allattamento. 2. Rifiuto on inabilità a praticare la contraccezione indipendentemente dal genere del paziente 3. PML con insorgenza di IRIS (sindrome infiammatoria da ricostituzione immunitaria) documentata mediante RMN. 4. Trattamento precedente con interleuchina-7. 5. Antigene di superficie dell’epatite B (HbsAg) positivo. 6. ALT e/o ASAT &gt; 5 x ULN. 7. Uso di altri trattamenti in fase di sperimentazione o interventistici, nei 3 mesi precedenti l'inclusione nello studio. 8. Qualsiasi tumore maligno ad eccezione del sarcoma di Kaposi che non necessita chemioterapia. 9. Altra infezione opportunistica del sistema nervoso centrale in corso. 10. Tubercolosi attiva. 11. Altra malattia grave in corso o altre patologie (quali malattia autoimmune, malattia mentale grave) che, secondo lo sperimentatore, renderebbero il soggetto non idoneo all'arruolamento.
    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.
    L'endpoint primario di efficacia sarà la percentuale di pazienti con eliminazione del JCV dopo 3 mesi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be assessed at 3 months.
    3 mesi.
    E.5.2Secondary end point(s)
    • Biological activity: o kinetics of JCV change in CSF will be analysed using both:  the individual regression slope of CSF JCV load over the first three months and beyond  a time to event approach o changes of the CD3, CD4, CD8 cell counts o changes of specific T-cell response against the JCV • Clinical activity: o overall survival at M12 o clinical status improvement of the patient throughout the study period o residual neurological sequelae at M12
    • Attività biologica: o la cinetica della variazione del JCV nell'LCS sarà analizzata a mezzo di:  pendenza della retta di regressione individuale della carica virale JCV nell'LCS nei primi tre mesi ed oltre  un approccio ''time-to-event'' o variazioni della conta delle cellule CD3, CD4 e CD8 o variazioni della risposta delle cellule T specifiche contro il JCV • Attività clinica: o sopravvivenza globale al mese 12 o miglioramento dello stato clinico del paziente durante il periodo dello studio o sequele neurologiche residue al mese 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    D0, D7, D14, D21, D28, M2, M3, M6, M12
    G0, G7, G14, G21, G28, M2, M3, M6, 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 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 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
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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 No
    F.1.1Number of subjects for this age range: 0
    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.
    Se il paziente è incapace dal punto di vista medico e/o legalmente incompetente ad acconsentire a partecipare allo studio, un rappresentante legale pùo dare il consenso per il paziente.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    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)
    Standard of care
    Il trattamento medico non saranno forniti dallo Sponsor al completamento di questo studio clinico. Standard di trattamento di cura e la gestione continuer ad essere fornito dal medico del paziente.
    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 Decision2012-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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