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    Summary
    EudraCT Number:2021-002212-31
    Sponsor's Protocol Code Number:NEMUS
    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:2021-07-06
    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 number2021-002212-31
    A.3Full title of the trial
    NEurotrophins Mimetic compound for the treatment of diabetic foot UlcerS
    Composto mimetico delle neurotrofine per il trattamento delle ulcere del piede diabetico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NEurotrophins Mimetic compound for the treatment of diabetic foot UlcerS
    Composto mimetico delle neurotrofine per il trattamento delle ulcere del piede diabetico
    A.3.2Name or abbreviated title of the trial where available
    NEMUS
    NEMUS
    A.4.1Sponsor's protocol code numberNEMUS
    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 SponsorMIMETECH SRL
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMimeTech Srl
    B.5.2Functional name of contact point-
    B.5.3 Address:
    B.5.3.1Street AddressVia della Cernaia 21
    B.5.3.2Town/ cityFirenze
    B.5.3.3Post code50129
    B.5.3.4CountryItaly
    B.5.6E-mailfederico.cozzolino@mimetech.eu
    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 nameUdonitrectag
    D.3.2Product code [MT8 o MT2-L]
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUdonitrectag
    D.3.9.1CAS number 1458063-51-8
    D.3.9.2Current sponsor codeMT8
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic Foot Ulcer
    Ulcera del piede diabetico
    E.1.1.1Medical condition in easily understood language
    Diabetic Foot Ulcer
    Ulcera del piede diabetico
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10012664
    E.1.2Term Diabetic foot ulcer
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10012664
    E.1.2Term Diabetic foot ulcer
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10012664
    E.1.2Term Diabetic foot ulcer
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10012664
    E.1.2Term Diabetic foot ulcer
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10012664
    E.1.2Term Diabetic foot ulcer
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety, tolerability, and pharmacokinetic profile of udonitrectag (MT8) added to standard of care versus standard of care alone in the treatment of Diabetic Foot Ulcers.
    Valutare la sicurezza, la tollerabilità e il profilo farmacocinetico di due differenti dosi di udonitrectag (MT8) in aggiunta a terapia standard nel trattamento delle ulcere del piede diabetico rispetto alla sola terapia standard.
    E.2.2Secondary objectives of the trial
    To determine and to compare the ability of two doses of udonitrectag in promoting reduction of the ulcer area during 6-week treatment.
    Determinare e confrontare la capacità di due dosi di udonitrectag nel promuovere la riduzione dell'area dell'ulcera durante il trattamento di 6 settimane.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed and dated informed consent form;
    2. Stated willingness to comply with all study procedures and availability for the duration of the study;
    3. Male or female;
    4. Age = 18 years;
    5. Diagnosis of type 1 or 2 diabetes mellitus;
    6. A diabetic foot wound grade I or II, according to the TEXAS diabetic wound classification system (Table 5) and grading 1 in the PEDIS infection scale (Table 6);
    7. TpO2= 30 mmHg or ABI (Ankle Brachial Index) = 0.70;
    8. Ulcers not healing with standard good care in the last 2-weeks (ulcer area reduction less than 20% versus baseline);
    9. Presence of ulcer with an area from 2 to 15 cm2 measured by MolecuLight i:XTM Wound Imaging Device;
    10. Females of childbearing potential must have a negative urine pregnancy test prior to commencing the study;
    11. Glycated haemoglobin (HbA1c) levels =10% (or = 86 mmol/mol);
    12. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation;
    13. For males with partners reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
    1. Modulo di consenso informato firmato e datato.
    2. Dichiarata disponibilità a rispettare tutte le procedure dello studio e disponibilità per tutta la durata dello studio.
    3. Maschio o femmina
    4. Età =18 anni.
    5. Diagnosi di diabete mellito di tipo 1 o 2.
    6. Una ferita diabetica al piede di grado I o II, secondo il sistema di classificazione delle ferite diabetiche TEXAS e di grado I nella classificazione PEDIS.
    7. Indice TpO2 =30 mmHg o ABI =0.70.
    8. Ulcere che non guariscono con un buon trattamento standard nelle ultime 2 settimane (riduzione dell'area ulcerosa inferiore al 20% rispetto al basale).
    9. Presenza di ulcera con un'area da 2 a 15 cm2 misurata mediante MolecuLight i:XTM Wound Imaging Device.
    10. Le femmine in età fertile devono avere un test negativo di gravidanza nelle urine prima di iniziare lo studio.
    11. Livelli di emoglobina glicata =10% (or = 86 mmol/mol).
    12. Per le femmine in età riproduttiva: uso di una contraccezione altamente efficace per almeno 1 mese prima dello screening e accordo per l'uso di tale metodo durante la partecipazione allo studio.
    13. Per i maschi con partner in età riproduttiva: uso di preservativi o altri metodi per garantire una contraccezione efficace con il partner per tutta la durata dello studio.
    E.4Principal exclusion criteria
    1. Pregnancy or Lactation. Female patients who are pregnant or breast-feeding;
    2. Childbearing potential female patients who do not agree to use an acceptable method of contraception during the study, providing they are not pregnant or lactating;
    3. Presence of infected foot ulcer of grade >1 (according to the PEDIS diabetic foot ulcer classification system), diagnosed via a clinic examination;
    4. Participation in any other clinical trial or currently receiving any other investigational product(s) within 30 days prior to study treatment (Visit 1a o Visit 1b);
    5. Severe renal failure defined as eGFR< 30 ml/min;
    6. Clinical diagnosis of peripheral vascular disease (PVD) requiring a prompt revascularization;
    7. Any surgery planned in the study period, including scheduled amputation at the ulcer site;
    8. Diagnosis of severe medical conditions such as severe heart failure or severe hepatic disease, according to the Investigator’s judgment or presence of concurrent illness indicating a short life expectancy;
    9. Diagnosis of current cancer;
    10. Diagnosis of current of autoimmune disorders;
    11. Immunosuppressed subjects;
    12. History of any medical or psychiatric conditions that, according to the Investigator, may increase the risks associated with the study’s participation or investigational product(s) administration;
    13. Patients with diabetes under poor control (HbA1c of >10% or >86 mmol/mol);
    14. Patients with ulcers due to other etiologies (e.g., arterial insufficiency);
    15. Current use of high-dose steroids or immunosuppressants;
    16. Febrile illness within one month from Visit 1b;
    17. Current smoker;
    18. Blood pressure above 180/100 or heart rate>100 bpm or Respiratory frequency >30;
    19. Patients who show reductions or enlargement of the ulcer area >20% during the screening phase will not be enrolled for the study.
    1. Pazienti in gravidanza o in allattamento.
    2. Pazienti in età fertile che non accettano di utilizzare un metodo di contraccezione accettabile per la durata dello studio.
    3. Presenza di ulcera del piede infetta di grado >1 (secondo il sistema di classificazione dell'ulcera del piede diabetico PEDIS), diagnosticata tramite esame clinico.
    4. Partecipazione a qualsiasi altro studio clinico o essere in trattamento con qualsiasi altro prodotto o prodotti sperimentali nei 30 giorni prima di ricevere il trattamento sperimentale.
    5. Grave insufficienza renale definita come eGFR< 30 ml/min.
    6. Diagnosi clinica di malattia vascolare periferica che richiede una pronta rivascolarizzazione.
    7. Qualsiasi intervento chirurgico pianificato nel periodo di studio, compresa l'amputazione programmata nel sito dell'ulcera.
    8. Diagnosi di gravi condizioni mediche come grave insufficienza cardiaca o grave malattia epatica, secondo il giudizio dello sperimentatore, o la presenza di malattia concomitante che indica una breve aspettativa di vita.
    9. Diagnosi di cancro/neoplasia.
    10. Diagnosi di malattie autoimmuni.
    11. Soggetti immunosoppressi/immunodeficienti.
    12. Storia di qualsiasi condizione medica o psichiatrica che, secondo il giudizio dello sperimentatore, possa aumentare i rischi associati alla partecipazione allo studio o alla somministrazione di prodotti sperimentali.
    13. Pazienti con diabete con inadeguato controllo metabolico definito come HbA1c >10% o >86 mmol/mol.
    14. Pazienti con ulcere dovute ad altre eziologie (ad esempio, insufficienza arteriosa).
    15. Uso corrente di steroidi ad alte dosi o immunosoppressori.
    16. Malattia febbrile entro un mese dall’inizio dello studio.
    17. Attuale fumatore.
    18. Pressione sanguigna superiore a 180/100 mmHg o frequenza cardiaca>100 bpm o frequenza respiratoria >30.
    19. Pazienti che mostrano riduzione o ampliamento dell'area dell’ulcera >20% durante la fase di screening.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability:
    I. Nature, frequency, severity, and timing of adverse events including skin irritation, haematological, hepatic, and renal events;
    II. Clinical laboratory results during and following udonitrectag administration;
    III. Pharmacokinetics.
    Sicurezza e tollerabilità:
    I. Natura, frequenza, gravità e tempistica di eventi avversi tra cui irritazione cutanea, eventi ematologici, epatici e renali;
    II. Risultati clinici di laboratorio durante e dopo il trattamento con udonitrectag;
    III. Farmacocinetica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 settimane
    E.5.2Secondary end point(s)
    Efficacy: percentage of ulcer area reduction during 6-week treatment, defined as percentage change area ((Area0 - Areat)/Area0)*100.
    Efficacia: percentuale di riduzione dell'area ulcerosa durante il trattamento di 6 settimane, definita come area di variazione percentuale ((Area0 - Areat)/Area0)*100
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 settimane
    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 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) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Terapia standard
    Standard of care
    E.8.2.4Number of treatment arms in the trial3
    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 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.1.1.1In 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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    In case of non-healing of the ulcer under study after 6 weeks of treatment, the patient will be treated and monitored according to normal clinical practice.
    In caso di mancata guarigione dell'ulcera in studio dopo le 6 settimane di trattamento, il paziente verrà trattato e monitorato secondo normale pratica clinica.
    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 Decision2021-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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