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    Summary
    EudraCT Number:2019-001696-36
    Sponsor's Protocol Code Number:IL2REG
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-001696-36
    A.3Full title of the trial
    Study of efficacy of low-dose recombinant human interleukin-2 in immunological changes associated with depression (IL2REG)
    Studio di efficacia dell’interleuchina-2 ricombinante umana a basso dosaggio nelle alterazioni immunologiche associate alla depressione (IL2REG)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy of low-dose interleukin-2 in alteration of the immune system associated with depression
    Studio di efficacia dell’interleuchina-2 a basso dosaggio nelle alterazioni del sistema immunitario associate alla depressione
    A.3.2Name or abbreviated title of the trial where available
    IL2REG
    IL2REG
    A.4.1Sponsor's protocol code numberIL2REG
    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 SponsorOSPEDALE SAN RAFFAELE
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUnione Europea H2020 –SCI 2016-2017
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFrancesco Benedetti
    B.5.2Functional name of contact pointPsichaitria e Psicobiologia Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Stamira D'ancona 20
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20127
    B.5.3.4CountryItaly
    B.5.6E-mailbenedetti.francesco@hsr.it
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameAldesleuchina
    D.3.2Product code [Aldesleuchina]
    D.3.4Pharmaceutical form Powder for 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 INNALDESLEUCHINA
    D.3.9.1CAS number 110942-02-4
    D.3.9.2Current sponsor codeProleukin
    D.3.9.3Other descriptive nameAldesleukin
    D.3.9.4EV Substance CodeSUB05303MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number900000 to 1100000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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) Yes
    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
    Depressive episode in course of mood disorder
    Episodio depressivo in corso di disturbo dell’umore
    E.1.1.1Medical condition in easily understood language
    Depressive episode in course of mood disorder
    Episodio depressivo in corso di disturbo dell’umore
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10012402
    E.1.2Term Depressive episode
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    prove the improvement of T regulatory cells response following add-on treatment with IL-2 (Aldesleukin) in patients affected by mood disorder win an ongoing depressive episode
    Dimostrare il miglioramento della risposta delle cellule T regolatrici (Treg) in seguito a trattamento aggiuntivo con IL-2 (Aldesleuchina) in pazienti con disturbo dell’umore in fase depressiva.
    E.2.2Secondary objectives of the trial
    To prove the safety of low-dose IL-2 in patients with a depressive episode in course of mood disorder (major depressive o bipolar disorder) and demonstrate an improvement of immune homeostasis, including the response on T regulatory cells, following add-on treatment with IL-2.
    determinare la sicurezza di IL-2 a basso dosaggio in pazienti con episodio depressivo in corso di disturbo dell’umore (depressione maggiore ricorrente o disturbo bipolare) e dimostrare il miglioramento dell’omeostasi immune, inclusa la risposta delle cellule T regolatrici, in seguito a trattamento aggiuntivo con IL-2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed Informed consent
    - A major depressive episode according to DSM-V criteria in the course of a mood disorder (BD and MDD)
    - Age 18-65 years;
    - Already on a mood stabilizer and/or antidepressant treatment
    - Consenso informato
    - Episodio depressivo in corso di disturbo dell’umore (BD e MDD) in accordo ai criteri del DSM-V;
    - Età 18-65 anni;
    - già in trattamento con stabilizzante dell’umore e/o trattamento antidepressivo
    E.4Principal exclusion criteria
    Contraindication to ld-IL2 therapy:
    Hypersensitivity to active substance or excipient;
    Active infection requiring antibiotics therapy;
    Organ failure (e.g., liver, kidney, lung and heart);
    Immunosuppressed patient
    Hepatotoxic, nephrotoxic, myelotoxic or cardiotoxic drugs
    Other chronic diseases
    Signs of active infection requiring treatment
    Previous history of organ transplantation
    Leukocytes < 4000 / mm3, platelets < 100 000 /mm3, Hemoglobin < 10.0 g/dL, red cell count < 3.5 106/mm3.
    Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder (NSAD, immunosuppressant IV-Ig based treatment);
    Ongoing fever
    uncontrolled diabetes type I or II;
    Existing cancer or history of cancer in the last 5 years (except skin epidermoid cancer or in-situ cervix cancer);
    Existing or planned pregnancy or lactation;
    Women sexually active not using an effective method of contraception
    Person under legal protection
    Pregnant and parturient and Breast feeding women
    Legally detained person
    Under the age of majority
    Immediate risk for suicidal behaviour (3 on HamD-17 rating scale or 5 on MAD Rating Scale);
    Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS),
    Parkinson’s or Alzheimer’s disease, or any other serious condition likely to interfere with the conduct of the trial;
    Participation to an interventional study concomitantly or within 30 days prior to this study, except in the cohorts studies aiming at the analysis of immuno-inflammatory biomarkers and/or brain imaging studies.
    Patients thought to be unreliable or incapable of complying with the requirements of the protocol;
    Patient is relative of, or staff directly reporting to the investigator;
    Patient is employee of the sponsor.
    Controindicazione alla terapia con IL-2:
    Ipersensibilità al principio attivo o eccipiente;
    Infezione attiva che richieda terapia antibiotica;
    insufficienza d'organo (ad es. Fegato, reni, polmoni e cuore);
    Paziente immunosoppressore
    Farmaci epatotossici, nefrotossici, mielotossici o cardiotossici
    Altre malattie croniche
    Segni di infezione attiva che richiedono un trattamento
    Storia precedente di trapianto di organi
    Leucociti <4000 / mm3, piastrine <100 000 / mm3, emoglobina <10,0 g / dl, conta dei globuli rossi <3,5 106 / mm3.
    Uso di farmaci antinfiammatori su base regolare per un disordine cronico infiammatorio / autoimmune (NSAD, trattamento immunosoppressivo IV-Ig);
    Febbre continua
    diabete non controllato di tipo I o II;
    Presenza di cancro o storia di cancro negli ultimi 5 anni (ad eccezione del carcinoma epidermoide cutaneo o del carcinoma della cervice in situ);
    gravidanza o allattamento esistenti o programmati;
    Donne sessualmente attive che non usano un metodo contraccettivo efficace
    Persona sotto protezione legale
    Donne in gravidanza, partorienti e che allattano al seno
    Persona legalmente detenuta
    Minorenni
    Rischio immediato di comportamento suicidario (3 su scala di valutazione HamD-17 o 5 su scala di valutazione MAD);
    Infezione da HIV nota o Sindrome da immunodeficienza acquisita (AIDS) clinicamente manifesta
    morbo di Parkinson o di Alzheimer o qualsiasi altra condizione grave che possa interferire con la conduzione dello studio;
    Partecipazione a uno studio interventistico in concomitanza o nei 30 giorni precedenti questo studio, eccetto negli studi di coorte finalizzati all'analisi di biomarcatori immunoinfiammatori e / o studi di imaging cerebrale.
    Pazienti ritenuti inaffidabili o incapaci di soddisfare i requisiti del protocollo;
    Il paziente è parente o parte dello staff che riferisce direttamente allo sperimentatore;
    Il paziente è dipendente dello sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage Treg fold increase at Day 5 compared to baseline
    aumento percentuale di cellule Treg al giorno 5 rispetto al basale
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of the induction phase after 5 days of treatment
    alla fine della fase di induzione dopo 5 giorni di trattamento.
    E.5.2Secondary end point(s)
    to assess the safety of ld-IL2 in patients with mood disorder experiencing a depressive relapse and to demonstrate improvement of immune homeostasis, including the T regulatory cell (Tregs) response, under add on ld-IL2 in relation along with symptomatic assessment of mood improvements in patients with mood disorder experiencing a depressive relapse
    Efficacy of ld-IL2 to activate Tregs will be monitored by the peak response to the induction course (at day 5; primary outcome) and by measuring the Treg level at the end of the trial (secondary outcome);
    Increase/decrease in T helpers 1 (Th1), T helpers 2 (Th2) and T helper 17 (Th17) cells;
    Increase in the balance between naïve and memory T helper cells;
    Alterations in the balance between the Th17/Tregs;
    Decrease in inflammatory gene expression (cluster 1 and 2 gene expression) in circulating leukocytes;
    Decrease in circulating levels of high sensitivity C Reactive Protein (hCRP), interleukin-6 (IL-6), C-C motif chemokine ligand 2 (CCL2), Pentraxin 3 (PTX-3), soluble interleukin-2 receptor (sCD25), stem cell factor (SCF), brain-derived neurotrophic factor (BDNF).
    Frequency and type of adverse events.
    l’efficacia di IL-2 a basso dosaggio nell’attivare le cellule Tregs verrà monitorata dalla risposta più alta alla fase di induzione (al giorno 5; outcome primario) e misurando i livelli delle cellule Treg alla fine del trial (outcome secondario);
    • Aumento/diminuzione delle seguenti cellule: Th1, Th2 e Th17;
    • aumento nell’equilibrio tra cellule T helper cells naïve e di memoria
    • Alterazioni nell’equilibrio tra Th17/Tregs;
    • Diminuzione dell’espressione genica dei geni infiammatori (cluster 1 e 2) nei leucociti circolanti;
    • Diminuzione nei livelli circolanti di hCRP, IL-6, CCL2, PTX-3, sCD25, SCF, BDNF.
    • Frequenza e tipo di eventi avversi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy will be evaluated at the end of treatment.
    Safety will be evaluated though the daily monitoring of adverse events
    L’efficacia verrà testata alla fine del trattamento.
    La sicurezza verrà testata tramite il monitoraggio giornaliero della comparsa di eventi avversi
    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 No
    E.6.7Pharmacodynamic No
    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 No
    E.8.1.4Double blind Yes
    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 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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 years2
    E.8.9.1In the Member State concerned months2
    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 months2
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 36
    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)
    At the end of the follow-up the subjects in charge to the hospital will be followed as outpatient by their psychiatrist who will check the psychiatric symptomatology, possible adjustment of the ongoing treatment, and will report any adverse events attributable to study. During the three months after follow-up, those who are no longer in charge to the hospital will be contacted by telephone by the investigator to monitor the possible occurrence of adverse events.
    Dopo il follow-up i soggetti in carico alla struttura verranno seguiti ambulatorialmente dal loro curante che provvederà al controllo della sintomatologia psichiatria, all’eventuale aggiustamento del trattamento in corso e a riportare eventuali eventi avversi riconducibili allo studio. Nei tre mesi successivi al follow-up, coloro che non dovessero essere più in carico alla struttura verranno ricontattati telefonicamente dall’investigatore per monitorare l’eventuale insorgenza di eventi avversi.
    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 Decision2019-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
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