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    Summary
    EudraCT Number:2016-000488-17
    Sponsor's Protocol Code Number:LUPIL-2
    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:2019-05-10
    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 number2016-000488-17
    A.3Full title of the trial
    A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE)
    A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)
    Titolo della sperimentazione in linguaggio non tecnico, facilmente comprensibile: Studio per valutare l'efficacia e la
    sicurezza del farmaco in studio, quando i pazienti con lupus eritematoso sistemico {SLE) attivo da moderate a severe ricevono ii
    dosaggio di ILT-101.
    A.3.2Name or abbreviated title of the trial where available
    A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage o
    Studio per valutare l'efficacia e la sicurezza de! farmaco in studio, quando i pazienti con lupus er
    A.4.1Sponsor's protocol code numberLUPIL-2
    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 SponsorILTOO PHARMA
    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 supportILTOO PHARMA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationILTOO PHARMA
    B.5.2Functional name of contact pointJérémie MARIAU
    B.5.3 Address:
    B.5.3.1Street AddressHopital Pitié-Salpétrière 47/83, Bd de l'Hopital
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75013
    B.5.3.4CountryFrance
    B.5.4Telephone number33 157 274561
    B.5.5Fax number00 000 000000
    B.5.6E-mailj.mariau@iltoopharma.fr
    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 nameILT-101
    D.3.2Product code ILT-101
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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 code110942-02-4
    D.3.9.3Other descriptive nameALDESLEUCHINA
    D.3.9.4EV Substance CodeSUB05303MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Munit million units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.2
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systematic Lupus Erythematosus
    Lupus eritematoso sistemico (LES)
    E.1.1.1Medical condition in easily understood language
    Systematic Lupus Erythematosus(SLE) is an automimmune disease in which the body's immune system mistakenly attacks healthy tissue.
    Lupus eritematoso sistemico (LES) è una malattia autoimmune in cui il sistema immunitario del corpo attacca arroneamnte il tessuto sano.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is the evaluation of the clinical efficacy of ILT-101 (1.5 MUI of IL-2 daily for 5 days and then weekly from day 8 to day 162) at week 12 in active SLE patients with moderate to severe disease activity.
    l'obbiettivo primario dello studio è la valutazione dell'efficacia clinica di ILT-101 (1.5MU di IL-2 al giorno per 5 giorni e poi ogni settimana dal giorno 8 al giorno 162) alla settimana 12 nei pazienti affetti da LEC attivo con malattia da moderata a grave attività.
    E.2.2Secondary objectives of the trial
    To assess:
    1/ Maintenance of clinical efficacy (at week 24) within responders (i.e.
    those with SRI-4 at week 12)
    2/ Maintenance of clinical efficacy at week 36 within responders
    3/ Safety of ILT-101 during the treatment period
    4/ Relationship between immunological cell subsets (Tregs) and clinical
    endpoints
    1/ Mantenimento dell'efficacia clinica (alla settimana 24) all'interno di responder (cioè quelli con SRI-4 alla settimana 12)
    2/Mantenimento dell'efficacia clinica alla settimana 36 nei responder
    3/Sicurezza di ILT-101 durante il periodo di trattamento
    4/ Relazione tra i sottoinsiemi immunologici cellulari (Treg) e endpoints clinici
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -- Age ≥ 18 years
    - Male or female
    - Having a confirmed diagnosis of SLE assessed by the presence of at least 4 of the criteria of American College of Rheumatology (ACR) list or of the Systemic Lupus International Collaborating Clinics (SLICC)
    list at least at diagnosis.
    - Having an active SLE characterised by:
    > SELENA-SLEDAI score ≥ 6
    > Positive for Anti-nuclear antibody (ANA), titre (≥1:80)
    > Positive for anti-dsDNA antibody
    > Low levels (below the laboratory normal range) of C3 or C4 complement components OR a SELENA-SLEDAI score ≥ 8
    - Being on stable background therapy (dose and type) before inclusion including any corticotherapy at dose ≥7.5mg/day but lower than 30mg/day or 0.5mg/kg/day whichever is the lower. Corticosteroids and antimalarial drug should be stable for 1 month prior to inclusion, immunosuppressant must be stable for 2 months prior to inclusion.
    - Using highly effective methods of contraception during the duration of the study, including oral, or injectable hormonal contraceptives or intrauterine device or systems, vasectomised partner, bilateral tubal occlusion or fully sexual abstinence
    - Having freely provided informed consent to participate in the study preceding any study procedure
    - Età ≥ 18 anni
    - Maschio o femmina
    - avere una diagnosi confermata di SLE valutato mediante la presenza di almeno 4 criteri dell'American College of Rheumatology (ACR) oppure del Systemic Lupus International Collaborating Clinics (SLICC) almeno alla diagnosi.
    - LES attivo caratterizzato da:
    • Punteggio SELENA-SLEDAI ≥ 6
    • Positività alla titolazione di anticorpi anti-nucleo (ANA) (≥1:80)
    • Positività agli anticorpi anti-dsDNA
    • Livelli bassi (inferiori al range normale di laboratorio) di frazioni del complemento C3 o C4 OPPURE un punteggio SELENA-SLEDAI ≥ 8
    - Essere stabili alla terapia di base (dosaggio e tipo) da almeno 4 settimane prima dell'inclusione, compresa qualsiasi corticoterapia a un dosaggio ≥7,5mg/giorno ma inferiore a 30mg/giorno o 0.5mg/kg/giorno, qualunque sia inferiore. Corticosteroidi e farmaci antimalarici devono essere stabili per un mese prima dell’inclusione, la terapia immunosoppressiva deve essere stabile per 2 mesi prima dell’inclusione.
    - devono usare metodi altamente efficaci di contraccezione durante il trattamento, se uomini o donne sessualmente attivi, tra cui contraccettivi ormonali orali o iniettabili e dispositivi o sistemi intrauterini, partner vasectomizzato, occlusione tubarica bilaterale, o l'astinenza sessuale pienamente.
    - Consenso informato volontario a partecipare allo studio prima dell'esecuzione di qualsiasi procedura.
    E.4Principal exclusion criteria
    - A known contraindication to treatment with IL-2:
    > Hypersensitivity to the active substance or to any of its excipients
    > Ongoing infection (requiring antibiotic treatment or fever≥38°C) at the time of inclusion
    > Blood oxygen saturation ≤ 90% in resting position
    > A previous organ allograft
    - Serious organ failure:
    > Renal functional impairment (glomerular Filtration Rate <60ml/min) OR (urinary protein ≥ 2g/24h with normal albuminemia)
    > Severe central nervous system manifestations
    > Heart failure of grade 3 or greater by the NYHA classification
    > Liver failure with transaminases more than 5 times the upper limit of normal
    - Any clinical evidence of active chronic infection, HIV infection (positive serum antibodies against HIV1/2), active or chronic hepatitis B infection (positive for HBs-Ag in serum), active or chronic
    hepatitis C infection (positive for serum antibodies against HCV).
    - Patient with clinical significant pleuritis with pleural effusion and/or pericarditis
    - Patient diagnosed with type 1 diabetes and/or Crohn’s disease
    - Use of Benlysta (belimumab) in the past 4 weeks
    - Use of or Rituximab in the past 24 weeks (6 months) prior to inclusion
    - Use of cyclosporine, interferon alpha and antimitotic agents in the past 4 weeks
    - Use of any prohibited drug prior to the study participation as described in section 9.3 and 9.4
    - Vaccination with live attenuated virus in the last month
    - Necessity for application of radiographic iodinated contrast media during and 2 weeks after the completion of the treatment
    - A white blood cell count <2000/ mm 3, platelets <50 000/ mm 3 or Anemia with Hb≤0.8 g/dl
    - Elevated TSH and T4
    - Existing cancer or a history of cancer treated within the past five years, except cervical carcinoma in situ or basal cell carcinoma
    - Veins in a poor state unsuitable for venepuncture
    - Major surgery in the previous two months or anticipated during the course of the Study period
    - In women, pregnancy or lactation
    - Psychiatric pathology or any other chronic illness or addiction that might interfere with the ability to provide informed consent or to comply with the requirements of the Protocol
    - A patient under legal protection
    - Having received any investigational product (small molecule or biologic) or commercially available biologic agent within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater
    -- Nota controindicazione al trattamento con IL-2;
    • Ipersensibilità alla sostanza attiva o a uno qualsiasi dei suoi eccipienti
    • Infezione in corso (che richiede un trattamento antibiotico o febbre >38°C) al momento dell'inclusione
    • Saturazione dell'ossigeno nel sangue ≤ 90% in posizione supina
    • Storia di allotrapianto di un organo
    - Insufficienza grave di un organo;
    • Insufficienza renale (velocità di filtrazione glomerulare < 60ml/min) o (proteina urinaria ≥ 2g/24h con albuminemia normale
    • Manifestazioni gravi del sistema nervoso centrale
    • Insufficienza cardiaca di grado 3 o superiore secondo la classificazione NYHA
    • Insufficienza epatica con transaminasi oltre 5 volte superiori al limite superiore di normalità
    - - Qualsiasi evidenza clinica di infezione cronica attiva , infezione da HIV (positività sierica ahli anticorpi anti- HIV1/2), infezione da Epatite B attiva o cronica (positività sierica ad HBs-Ag), infezione da Epatite C attiva o cronica (positività sierica agli anticoprpi anti-HCV).
    - Pazienti con pleurite clinicamente significativa con versamento pleurico e/o pericardite
    - Pazienti con diagnosi di Diabete di tipo I e/o malattia di Crohn
    .
    - Uso di Benlysta (belimumab) o Rituximab nelle ultime 4 settimane
    - - Uso di Rituximab nelle ultime 24 settimane (6 mesi) prima dell’inclusione

    - Uso di ciclosporina, interferone alfa o agenti antimitotici nelle ultime 4 settimane
    - L'uso di qualsiasi sostanza proibita prima della partecipazione allo studio come descritto nella sezione 9.3 e 9.4
    - Vaccinazione con virus vivo attenuato nell'ultimo mese;
    - Necessità di effettuare radiografie con mezzo di contrasto iodinato durante e dopo 2 settimane il completamento del trattamento

    - Conta di globuli bianchi <2.000/mm3, o piastrine <50.000/mm3, anemia con Hb≤0.8 g/dl
    - TSH e T4 elevati
    - Malignità presente o passata, trattata negli ultimi cinque anni e in remissione, ad eccezione del carcinoma cervicale in situ o del carcinoma cellulare basale
    - Vene in cattive condizioni, non idonee per l'iniezione in vena
    - Interventi di Chirurgia maggiore negli ultimi due mesi o pianificata durante il corso dello studio
    - Per le pazienti, stato di gravidanza o allattamento
    - Patologia psichiatrica o qualsiasi altra malattia cronica o dipendenza che potrebbe interferire con la capacità di fornire il consenso informato o di rispettare i requisiti del protocollo
    - Paziente sotto tutela legale
    - Ricezione di qualsiasi farmaco sperimentale (a piccole molecole o biologico) o agente biologico disponibile in commercio entro 4 settimane o 5 emivite prima della firma del modulo di consenso (ICF), qualunque sia maggiore
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with SLE responder index of 4 (SRI-4) at week 12
    SRI-4 response being definied as (1) a ≥ 4-point reduction in SELENA-SLEDAI score as compared to baseline, and (2) no new BILAG A score or ≤ 1new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0,3 points
    Percentuale di pazienti con indice SLE responder di 4 (SRI-4) alla settimana 12
    la risposta SRI-4 essendo definita come (1) una riduzione di ≥ 4 punti rispetto al basale nel punteggio SELENA-SLEDAI, e (2) nessun nuovo punteggio BILAG A o nuovo punteggio BILAG B ≤ 1, e (3) nessun deterioramento dal basale nella valutazione globale del medico di ≥ 0,3 punti.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after the baseline
    12 settimane dopo il basale
    E.5.2Secondary end point(s)
    - corticosteroids tapering
    -biological response
    -safety
    -Maintenance of clinical response from week 12 to 24
    -Early clinical response
    -other clinical assessments
    -Biological response
    - Mantenimento della risposta clinica
    - La diminuzione dei corticosteroidi
    -risposta biologica
    -sicurezza
    - Mantenimento della risposta clinica dalla settimana 12 alla settimana 24
    - risposta clinica precoce
    - altre valutazioni cliniche
    - risposta biologica
    E.5.2.1Timepoint(s) of evaluation of this end point
    please see protocol
    Si prega di consultare il protocollo
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 100
    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)
    there is currently no plan for the after care
    Non vi è attualmente un piano per dopo la cura
    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 Decision2016-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-02
    P. End of Trial
    P.End of Trial StatusCompleted
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