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    Summary
    EudraCT Number:2020-002966-15
    Sponsor's Protocol Code Number:LDX0419
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-22
    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 number2020-002966-15
    A.3Full title of the trial
    A phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with new-onset type 1 diabetes and preserved Beta-cell function at baseline.
    Studio di fase 2 multicentrico, randomizzato, controllato, in doppio cieco verso placebo, volto a valutare l'efficacia e la sicurezza di ladarixin, somministrato per via orale alla dose 400 mg due volte al giorno, in pazienti con diabete di tipo 1 all'esordio e con una funzionalità ß-cellulare preservata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the the efficacy and the safety of ladaraxin in patients with new-onset type 1 diabetes
    Studio volto a valutare l'efficacia e la sicurezza di ladarixin in pazienti con diabete di tipo 1 all'esordio
    A.3.2Name or abbreviated title of the trial where available
    N/A
    N/A
    A.4.1Sponsor's protocol code numberLDX0419
    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 SponsorDOMPé 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 supportDompè 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 organisationDompè farmaceutici S.P.A.
    B.5.2Functional name of contact pointMarta Marelli
    B.5.3 Address:
    B.5.3.1Street AddressVia Santa Lucia 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number3428402328
    B.5.6E-mailmarta.marelli@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 [DF2156A]
    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.3.9.2Current 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 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 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
    New-onset Type 1 Diabetes
    Diabete di tipo 1 all'esordio
    E.1.1.1Medical condition in easily understood language
    Type 1 Diabetes
    Diabete di tipo 1
    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 evaluate whether a 12 month treatment with ladarixin is effective to improve glycemic control in newly diagnosed T1D adult patients with preserved ß-cell function.
    Obiettivo di questo studio clinico è valutare se il trattamento con ladarixin per 12 mesi è efficace nel migliorare il controllo glicemico in pazienti adulti con diabete di tipo 1 all'esordio con funzionalità beta-cellulare preservata.
    E.2.2Secondary objectives of the trial
    The safety of ladarixin in the specific clinical setting will be evaluated
    Sarà valutata la sicurezza di ladarixin in tale contesto clinico specifico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Consented male and female patients aged 18-45 years, inclusive, with new-onset T1D (randomization scheduled to allow the administration of the study medication to start within 100 days from 1st insulin administration). Patients must be positive for at least one diabetes-related 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 multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII); must have a fasting C-peptide =0.205 nmol/L on two occasions
    Saranno inclusi nello studio pazienti di età compresa tra 18 e 45 anni inclusi, di entrambi i sessi, con diagnosi di T1D all’esordio (randomizzazione programmata in modo da consentire l’inizio della somministrazione del farmaco in studio entro 100 giorni dalla prima somministrazione di insulina) che abbiano dato il proprio consenso informato. I pazienti devono essere positivi ad almeno uno degli autoanticorpi associati al diabete (anti-GAD; IAA se ottenuto entro 10 giorni dall'inizio della terapia insulinica; IA-2; ZnT8), devono assumere o aver assunto insulina somministrata tramite iniezioni multiple giornaliere (MDI) o tramite dispositivi di infusione sottocutanea continua di insulina (CSII); devono avere valori a digiuno di C-peptide > 0.205 nmol/L in due occasioni.
    E.4Principal exclusion criteria
    Patients will be excluded if they have any other chronic disease (including type 2 diabetes), apart from patients with autoimmune hypothyroidism requiring thyroid hormone replacement only; 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. ß-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, inhaled or systemically injected steroids) 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 first 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); hepatitis A (IgM), hepatitis B (not due to immunization), hepatitis C and HIV positive serologic status. Also, pregnant or breastfeeding women or patients unwilling to use effective contraceptive measures (females and males) will be excluded
    Saranno esclusi i pazienti con qualsiasi altra patologia cronica (incluso il diabete di tipo 2), ad eccezione dei pazienti con ipotiroidismo autoimmune che richiedono solo terapia sostitutiva con ormoni tiroidei; con insufficienza renale moderata o severa valutata come velocità di filtrazione glomerulare stimata (eGFR) <60 mL/min/1.73 m2 calcolata mediante l'equazione sviluppata dalla Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI); con disfunzione epatica (ALT/AST superiori di tre volte il limite superiore di normalità e bilirubina totale > 3 mg/dL [>51.3 µmol/L]); con ipoalbuminemia (albumina serica < 3 g/dL); con QTcF > 470 msec; con una storia di patologie/anomalie cardiovascolari clinicamente significative, pazienti che hanno manifestato un episodio di chetoacidosi o coma ipoglicemico nelle 2 settimane precedenti, pazienti con nota ipersensibilità a farmaci antiinfiammatori non steroidei.
    Saranno anche esclusi i pazienti in terapia con farmaci metabolizzati dal citocromo CYP 2C9 con un basso indice terapeutico (per es. fenitoina, warfarina, sulfaniluree ipoglicemizzanti e alti dosaggi di amitriptilina (> 50 mg/die); pazienti che assumono, o hanno assunto nelle 2 settimane precedenti la randomizzazione, farmaci antidiabetici come metformina, sulfaniluree, glinidi, tiazolidinedioni, exenatide, liraglutide, inibitori della dipeptidil-peptidasi IV (DPP-IV,) inibitori del cotrasportatore 2 sodio/glucosio (SGLT-2) o amilina, o qualsiasi altro farmaco noto per influenzare la tolleranza al glucosio (per es. ¿-bloccanti, inibitori dell'enzima convertitore dell'angiotensina, interferoni, antimalarici a base di quinidina, litio, niacina, etc.). Inoltre, saranno esclusi i pazienti che assumono, o hanno assunto nel mese precedente la randomizzazione, qualsiasi farmaco immunosoppressivo (inclusi i corticosteroidi somministrati per via orale, inalatoria o iniettiva) o altre molecole in sperimentazione, incluse quelle che influenzano la risposta immunitaria e il sistema delle citochine.
    Ulteriori criteri di esclusione sono: infezione sistemica clinicamente significativa durante le 4 settimane precedenti la prima dose di farmaco sperimentale (es. infezione che richiede ospedalizzazione, interventi chirurgici o somministrazione di antibiotici per via intravenosa per la risoluzione dell’infezione; lo Sperimentatore dovrà inoltre valutare caso per caso altre infezioni, quali per esempio bronchiti, sinusiti, cellulite localizzata, candidosi, infezioni del tratto urinario, per determinare se la loro gravità sia tale da giustificare l’esclusione del soggetto dallo studio); positività a epatite A (IgM), epatite B (non da immunizzazione), epatite C o a HIV.
    Saranno anche escluse le donne in stato di gravidanza o durante l’allattamento e donne e uomini che non desiderano utilizzare un metodo efficace di contraccezione.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with HbA1c <7% and daily insulin requirement <0.50 IU/Kg/day
    Proporzione di pazienti con valori di HbA1 <7% con un fabbisogno giornaliero di insulina <0.50 IU/Kg/die
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12
    Mese 12
    E.5.2Secondary end point(s)
    Proportion of patients with HbA1c < 7% and daily insulin requirement <0.50 IU/Kg/day; Proportion of patients with a reduction in HbA1c% > 0.5% from baseline and daily insulin requirement <0.50 IU/Kg; 2-hour AUC of C-peptide response to the MMTT; Time in range (TIR) by Continuous Glucose Monitoring (CGM); HbA1c levels; Proportion of patients with HbA1c < 7% who did not experience severe hypoglycemic events during treatment; 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).; Number of self-reported episodes of severe hypoglycemia; Average (previous 3 days) daily insulin requirements (IU/kg/day); Estimated Glucose Disposal Rate (eGDR)
    Proporzione di pazienti con valori di HbA1c <7% con un fabbisogno giornaliero di insulina <0.50 IU/Kg/die; -Proporzione di pazienti con una riduzione dei valori di HbA1c > 0.5% rispetto al basale e con un fabbisogno giornaliero di insulina <0.50 IU/Kg/die; Area sotto la curva (AUC) dei livelli di C-peptide nelle 2 ore di risposta al MMTT (test di tolleranza del pasto misto-Mixed Meal Tolerance Test); Time in Range–(TIR), misurato attraverso un dispositivo di monitoraggio glicemico continuo CGM); Valori di HbA1c; Proporzione di pazienti con valori di HbA1c inferiori a 7% che non hanno riportato eventi ipoglicemici severi durante il trattamento; Ulteriori Indici di variabilità glicemica derivati dalle misurazioni tramite dispositivo CGM (AUC dei livelli di glucosio fuori dall’ intervallo di 70 –180 mg/dL, glicemia post-prandiale (PPG) nelle 2 ore dopo il pasto), ampiezza media dell’escursioni glicemiche(Mean Amplitude Glycemic Excursions- MAGE), continuous overall net glycemic action (CONGA)-n- parametro usato come indicatore della variabilità glicemica intra-giornaliera misuranta mediante CGM)-n, variabilità glicemica da giorno a giorno (Mean Of the Daily Differences- MODD), media glicemica giornaliera, SD (Deviazione Standard).; Numero degli episodi di ipoglicemia severa riportati dal paziente; Fabbisogno medio di insulina nei 3 giorni precedenti (IU/kg/die); Estimated Glucose Disposal Rate - eGDR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 6 and 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18; Month 6, 12, 18
    Mese 6 e 18; Mese 6, 12, 18; Mese 6, 18; Mese 6, 12,18; Mese 6, 12, 18; Mese 6, 12, 18; Mese 6, 12, 18; Mese 6, 12, 18; Mese 6, 12, 18; Mese 6, 12, 18]
    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 No
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Belgium
    Germany
    Italy
    United States
    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.
    Ai fini di questa sperimentazione, la conclusione della sperimentazione è la data dell'ultima visita dell'ultimo soggetto
    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 months6
    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 months6
    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: 75
    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 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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 75
    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 78 (month 18) 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.
    Dopo il completamento della visita di follow-up alla settimana 78 (mese 18), i pazienti riceveranno cure post studio come prescritto dal loro medico curante. Nessun trattamento pos-studio verra' fornito da 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 Decision2020-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-28
    P. End of Trial
    P.End of Trial StatusOngoing
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