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    The EU Clinical Trials Register currently displays   37950   clinical trials with a EudraCT protocol, of which   6228   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2014-002522-12
    Sponsor's Protocol Code Number:P121001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-12-10
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-002522-12
    A.3Full title of the trial
    European phase-II clinical trial evaluating efficacy of low dose rhIL-2 in patients with recently diagnosed type 1 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study conducted on humans in Europe to test the importance of a small molecule normally produced by the body, called Interleukin 2 (IL-2) to treat a specific type of diabetes (called type 1 diabetes)
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberP121001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/536/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAssistance Publique - Hôpitaux de Paris (AP-HP)
    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 supportFP7-Health-2012-innovation-1, European Commission
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAP-HP
    B.5.2Functional name of contact pointClinical Research and Development
    B.5.3 Address:
    B.5.3.1Street Addressavenue Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.4Telephone number003340275009
    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.3.4Pharmaceutical form Lyophilisate 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 INNAldesleukin
    D.3.9.1CAS number 8000048-25-1
    D.3.9.3Other descriptive nameINTERLEUKIN-2
    D.3.9.4EV Substance CodeSUB14225MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number to 1.50 - 3.00 mg/ml
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboLyophilisate for solution 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
    type -I diabetes
    E.1.1.1Medical condition in easily understood language
    type-I diabetes
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate efficacy of ILT-101 for the preservation of residual pancreatic β cells function
    2. To select the optimal regimen of administration of ILT-101
    E.2.2Secondary objectives of the trial
    To assess:
    1. Tregs expansion after an induction period and during maintenance therapy,
    2. Safety of low-dose rhIL-2 during the treatment period (1 year) and 1 year after its discontinuation
    3. Relation between Tregs expansion and preservation of residual pancreatic β cells function
    4. Clinical and biological responses according to (i) pubertal stage group, (i) time from diagnosis to treatment initiation, (iii) biomarkers of responses

    5. Throrough evaluation of the effects of low dose rhIL-2 on disease-specific immune responses
    6. identification of immune biomarkers for predicting/monitoring safety and efficacy of low dose rhIL- 2 treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age 6-35 years old
    -Male or female both using effective methods of contraception during treatment if sexually active.
    -Specifically; Females (if sexually active) with childbearing potential must use contraceptive methods that are considered as highly-effective
    (pearl index < 1). The following methods are acceptable: Oral , injectable, or implanted hormonal contraceptives (with the exception of oral minipills ie low-dose gestagens which are not acceptable (lynestrenol and norestisteron), Intrauterine device, Intrauterine system(for example, progestin-releasing toit)
    -beta HCG negative at inclusion;
    -With type-1 diabetes:
    Newly diagnosed (ADA criteria) at most two months between insulin initiation and anticipated start of experimental treatment Positive for one or more of the autoantibodies typically associated with T1D
    With a detectable peak C-peptide concentration during a standardised MMTT (≥0.2pmol/ml)
    patients with a stable blood glucose level and seric glycaemia between 60 mg/dL and 250 mg/dL verified at MMTT visit
    - Absence of clinically significant abnormal laboratory values (out of range and associated with clinical symptoms or signs) in haematology,
    biochemistry, thyroid, liver and kidney function;
    - Normal cardiac function: no documented history of heart disease and absence of family history of sudden death, normal ECG especially QTc duration within normal value (<480ms)
    - Free, informed and written consent
    E.4Principal exclusion criteria
    - Children under the age of 6 years old cannot be included
    - Patient who, before inclusion, have been treated with other antidiabetic medication than Insulin for more than 3 months consecutively
    - Chronic adrenal insufficiency known or fasting ACTH ≥2.5 ULN normal at inclusion after control;
    - Anti TPO present at inclusion and abnormal TSH and T4
    - Anti-transglutaminase positive at inclusion
    - Hypersensitivity to the active substance or to any of the excipients
    - Any major health problem including: any severe or evolutive autoimmune/ auto-inflammatory disease (other than type 1 diabetes) present
    at inclusion, any significant respiratory disease (such as moderate or severe COPD or asthma) only if requiring the chronic use of corticosteroids (whatever route of administration) and serious digestive
    - Patient with existing malignancy or history of malignancy
    - Major psychosocial instability with expected lack of compliance with insulin treatment, psychiatric pathology of patient or parents, or major problems of family dynamics;
    - Signs of active infection;
    - Any patient with obesity defined as BMI ≥ 35
    - Existence of a serious malfunction of a vital organ;
    - History of organ allograft;
    - Use of treatments not allowed in the Study
    - Vaccination with alive attenuated virus within 4 weeks of the first injection of the induction period and during the whole maintenance period
    - Pregnant female (confirmed by laboratory testing) or lactating
    - Participation in another clinical trial in the previous 3 months;
    - Lack of affiliation to a social security scheme (as a beneficiary or assignee)
    E.5 End points
    E.5.1Primary end point(s)
    AUC (T0-T120) of serum C-peptide, determined after a mixed meal tolerance test at month
    12, compared to baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after baseline
    E.5.2Secondary end point(s)
    · Serum concentrations of C-peptide after a 10 to 12-h fast, month 3, month 6, month 9,
    month 12, compared to baseline; and then month 15 and 24 during discontinuation
    · AUC (T0-T120) of serum C-peptide after a mixed meal tolerance test after treatment
    discontinuation at month 15 (adults only) and at month 24 (V60)
    · Diabetic monitoring will include assessment of daily insulin use at each visit
    · HbA1c and IDAA1c score at month 3, month 6, month 9, month 12, compared to
    baseline; and then month 15 and 24 during discontinuation period
    · Number of hypoglycaemic episodes (< 0.5 g/L on capillary sample) over 15 days before
    each visit compared to baseline; and after treatment discontinuation
    · Number of clinically significant symptomatic episodes of hypoglycaemia between each
    · Change in Tregs (expressed as percentage of CD4 and absolute numbers) at day 5
    compared to baseline.
    · Change in trough level of Tregs (%CD4+ and absolute numbers) at month 1, month 3,
    month 6, month 9, month 12, compared to baseline; and then month 15 and 24 after
    treatment discontinuation
    · Change in Tregs Foxp3 gene methylation at day 5, month 1, month 3, month 6, month 9,
    month 12 compared to baseline and then month 15 and month 24 after treatment
    · Cytokines and chemokines assays at day 5, month 1, month 3, month 6, month 9, month
    12 compared to baseline and then month 15 and month 24 after treatment
    · Transcriptome analysis at day 5, month 1, month 3, month 6, month 9, month 12
    compared to baseline and then month 15 and month 24 after treatment discontinuation
    · Genotyping: only at baseline
    · Treg phenotype and functionality in adults and adolescents only including pStat5 analysis
    day 5, month 1, month 3, month 6, month 9, month 12 compared to baseline and then
    month 15 and month 24 after treatment discontinuation
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to 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 Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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. 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 No
    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
    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 Yes
    F.1.1Number of subjects for this age range: 92
    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) Yes
    F. of subjects for this age range: 46
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 46
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 46
    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 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 Yes
    F. of subjects incapable of giving consent
    children age from 6
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 138
    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)
    patients will revert to standard treatment of care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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