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    Summary
    EudraCT Number:2020-001926-71
    Sponsor's Protocol Code Number:LDX0319
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-09-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-001926-71
    A.3Full title of the trial
    A phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the effect and safety of 400 mg twice a day oral ladarixin in patients with recent onset type 1 diabetes and a low residual β-cell function at baseline.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy and the safety of ladaraxin in adult and adolescent patients with recent onset type 1 diabetes
    A.3.2Name or abbreviated title of the trial where available
    GLADIATOR
    A.4.1Sponsor's protocol code numberLDX0319
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/124/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDompe farmaceutici s.p.a.
    B.1.3.4CountryItaly
    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 supportDompe farmaceutici s.p.a.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDompe farmaceutici s.p.a.
    B.5.2Functional name of contact pointStudy Medical Expert
    B.5.3 Address:
    B.5.3.1Street AddressVia Santa Lucia 6
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number00393472676311
    B.5.6E-mailenrico.minnella@dompe.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLadarixin
    D.3.2Product code DF 2156A
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLadarixin
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeDF 2156A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recent onset Type 1 Diabetes
    E.1.1.1Medical condition in easily understood language
    Type 1 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 21.1
    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
    The objective of this clinical trial is to assess whether ladarixin treatment has an effect to preserve Beta-cell function and delay the progression of T1D in adolescent and adult patients. The safety of ladarixin in the specific clinical setting will be also evaluated.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A PK sub-study is part of the trial, this has been the case since the trial start, but was not captured in the initial EudraCT form.

    Pharmacokinetic endpoints will be:
    - Plasma levels of 2156Y (acidic form of ladarixin) and relevant
    metabolites (DF2108Y, S-isomer; DF2227Y, R-isomer) in a subset of adolescents (14-17 years, inclusive) selected for full PK analysis [Time frame: day 1 and 14, then 24, 48 and 72 hours after the last IMP dose (morning dose) of the 1st treatment cycle].

    - Plasma levels of 2156Y (acidic form of ladarixin) and relevant
    metabolites (DF2108Y, S-isomer; DF2227Y, R-isomer) in the whole population [Time frame: within 96 hours after the last IMP dose in at least 2 treatment cycles].
    E.3Principal inclusion criteria
    Consented male and female patients aged 14-45 years, inclusive, with
    recent onset T1D (randomization scheduled to allow the administration
    of the study medication to start within 180 days from 1st insulin
    administration). Patients must be positive for at least one diabetesrelated auto-antibody (anti-GAD; IAA, if obtained within 10 days of the
    onset of insulin therapy; IA-2 antibody; ZnT8); must require, or have
    required insulin delivered via one or more separate subcutaneous
    injections or Continuous Subcutaneous Insulin Infusion (CSII); must
    have a fasting C-peptide below 0.205 nmol/L, but must retain a Beta-cell
    function as per peak stimulated (MMTT) C-peptide level >0.2 nmol/L.
    E.4Principal exclusion criteria
    Patients will be excluded if they have a type 2 diabetes or any other
    unstable chronic disease for which dose adjustment of specific
    medication is anticipated during the trial; moderate to severe renal
    impairment calculated by estimated Glomerular Filtration Rate (eGFR)
    <60 mL/min/1.73 m2 as determined using Chronic Kidney Disease
    Epidemiology Collaboration (CKD-EPI) creatinine equation; hepatic
    dysfunction (increased ALT/AST >3 x upper limit of normal and
    increased total bilirubin >3 mg/dL [>51.3 μmol/L]); hypoalbuminemia (serum albumin <3 g/dL); a QTcF > 470 msec.; a history of significant
    cardiovascular disease/abnormality; occurrence of an episode of
    ketoacidosis or hypoglycemic coma in the past 2 weeks; a known
    hypersensitivity to non-steroidal anti-inflammatory drugs. Patients on
    treatment with drugs metabolized by CYP2C9 with a narrow therapeutic
    index [i.e. phenytoin, warfarin, sulphanylurea hypoglycemics and high
    dose of amitriptyline (>50 mg/day)]; patients with past (within 2 weeks
    prior to randomization) or current use of antidiabetic agents as
    metformin, sulfonylureas, glinides, thiazolidinediones, exenatide,
    liraglutide, DPP-IV inhibitors, SGLT-2 inhibitors or amylin, or any
    medications known to influence glucose tolerance (e.g. beta-blockers,
    angiotensin-converting enzyme inhibitors, interferons, quinidine
    antimalarial drugs, lithium, niacin, etc.) will also be excluded. Patients
    will be excluded as well in case of past (within 1 month prior to
    randomization) or current administration of any immunosuppressive
    medications (including oral or systemic corticosteroids) and use of any
    investigational agents, including any agents that impact the immune
    response or the cytokine system. Additional exclusion criteria will be:
    significant systemic infection during the 4 weeks before the 1st dose of
    study drug (e.g., infection requiring hospitalization, major surgery, or
    i.v. antibiotics to resolve; other infections, e.g. bronchitis, sinusitis,
    localized cellulitis, candidiasis, or urinary tract infections, must be
    assessed on a case-by-case basis by the investigator regarding whether
    they are serious enough to warrant exclusion); History of positive status
    for hepatitis A (IgM), hepatitis B (not due to immunization), hepatitis C
    and HIV. Also, pregnant or breastfeeding women or patients unwilling to
    use effective contraceptive measures (females and males) will be
    excluded.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline in 2-hour AUC of C-peptide response to the MMTT [Primary endpoint. Time frame: Month 6].


    E.5.1.1Timepoint(s) of evaluation of this end point
    At month 6; Month 6 = Week 26 +/- 2 weeks
    E.5.2Secondary end point(s)
    - Change from baseline in 2-hour AUC of C-peptide response to the MMTT [Time frame: month 12, 18 and 24].
    - Change in HbA1c from baseline [Time frame: Month 6, 12 and 24]
    - Time in range (TIR) by Continuous Glucose Monitoring (CGM) [Time frame: Month 6, 12, 18, 24]
    - Proportion of patients with HbA1c <7% who did not experience severe hypoglycemic events during treatment [Time frame: Month 6, 12, 18 and 24].
    - Average (previous 3 days) daily insulin requirement (IU/kg/day) [Time frame: Month 6, 12, 18 and 24].
    - Proportion of patients with HbA1c <7% and daily insulin requirement <0.5 (IU/kg/day)
    - Additional Glucose Variability Indices derived from CGM (glucose AUC outside the target range of 70 – 180 mg/dL, 2-hour postprandial glucose (PPG), Mean Amplitude Glycemic Excursions (MAGE), continuous overall net glycemic action (CONGA)-n, Mean Of the Daily Differences (MODD), and mean daily blood glucose, SD (Standard Deviation). [Time frame: Month 6, 12, 18 and 24].
    - Number of self-reported episodes of severe hypoglycemia [Time frame: Month 6, 12, 18 and 24].
    - Percentage of patients not requiring insulin therapy {Time frame: Month 6, 12, 18 and 24]
    - Estimated Glucose Disposal Rate (eGDR) [Time frame: Month 6, 12, 18 and 24].



    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 6 = Week 26+2; Month 12 = Week 52+2; Month 18 = Week 78+2; Month 24 = Week 104+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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Georgia
    Israel
    Serbia
    United States
    Belgium
    Germany
    Italy
    Slovenia
    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
    For the purpose of this trial, the End of Study is defined as the date of the last visit of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months3
    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: 28
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 28
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 112
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 140
    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)
    After completion of the week 104 (month 24) follow-up visit, patients will receive post-study care as prescribed by their health care provider. No post-study treatment will be provided by Dompé.
    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 Decision2020-12-08
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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