Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-002478-20
    Sponsor's Protocol Code Number:PRECISESTUDY
    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:2021-10-22
    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 number2021-002478-20
    A.3Full title of the trial
    IDENTIFICATION OF SYNOVIAL BIOMARKERS OF RESPONSE TO IXEKIZUMAB IN REFRACTORY PSORIATIC
    ARTHRITIS: THE PRECISE STUDY.
    IDENTIFICATION OF SYNOVIAL BIOMARKERS OF RESPONSE TO IXEKIZUMAB IN REFRACTORY PSORIATIC
    ARTHRITIS: THE PRECISE STUDY.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IDENTIFICATION OF SYNOVIAL BIOMARKERS OF RESPONSE TO IXEKIZUMAB IN REFRACTORY PSORIATIC
    ARTHRITIS
    IDENTIFICAZIONE DI BIOMARCATORI SINOVIALI DI RISPOSTA AD IXEKIZUMAB NELL’ARTROPATIA PSORIASICA REFRATTARIA: LO STUDIO PRECISE.
    A.3.2Name or abbreviated title of the trial where available
    PRECISE
    PRECISE
    A.4.1Sponsor's protocol code numberPRECISESTUDY
    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 SponsorAZIENDA OSPEDALIERO UNIVERSITARIA DI FERRARA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportStudio no profit, investigator - initiated in parte finanziato da Ely Lilly, in parte da AOU Ferrara
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU Ferrrara
    B.5.2Functional name of contact pointAcQuaRI
    B.5.3 Address:
    B.5.3.1Street Addressvia Aldo Moro 8
    B.5.3.2Town/ cityCona Ferrara
    B.5.3.3Post code44124
    B.5.3.4CountryItaly
    B.5.4Telephone number0532236199
    B.5.6E-mailricerca@ospfe.it
    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 Yes
    D.2.1.1.1Trade name TALTZ
    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 nameTALTZ
    D.3.2Product code [IXEKIZUMAB]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNixekizumab
    D.3.9.1CAS number 1143503-69-8
    D.3.9.2Current sponsor codeLY-2439821
    D.3.9.3Other descriptive nameImmunoglobulin G4, anti-(human interleukin 17A) (human monoclonal LY2439821 gamma4-chain), disulfide with human monoclonal LY2439821 kappa-chain, dimer
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name TALTZ
    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 nameTALTZ
    D.3.2Product code [IXEKIZUMAB]
    D.3.4Pharmaceutical form Concentrate 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 INNIxekizumab
    D.3.9.1CAS number 1143503-69-8
    D.3.9.2Current sponsor codeLY-2439821
    D.3.9.3Other descriptive nameImmunoglobulin G4, anti-(human interleukin 17A) (human monoclonal LY2439821 gamma4-chain), disulfide with human monoclonal LY2439821 kappa-chain, dimer
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    PSORIATIC ARTHRITIS
    ARTROPATIA PSORIASICA
    E.1.1.1Medical condition in easily understood language
    PSORIATIC ARTHRITIS
    ARTRITE PSORIASICA
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The general aim of the PRECISE study (PRECIsion medicine at the SitE of inflammation) is to explore the synovial effect of IXE in PsA patients, assessing synovial biomarkers modifications after in vitro administration of IXE to different cells/tissues obtained from refractory to csDMARDs PsA patients, and comparing them with the clinical response to systemic IXE.
    The primary objective of the study is to evaluate if synovial biomarkers modifications in culture supernatants and cellular homogenates (after in vitro administration of IXE in assays of different cells/tissues obtained from refractory PsA patients) predict clinical response to systemic IXE at 12 weeks.
    Lo scopo generale dello studio PRECISE (PRECIsion medicine at the SitE of infiammation) è quello di esplorare l'effetto sinoviale di IXE in pazienti con PsA, valutando le modifiche dei biomarcatori sinoviali dopo somministrazione in vitro di IXE a diverse cellule / tessuti ottenuti da pazienti con PsA refrattari ai farmaci di fondo convenzionali, e confrontandoli con la risposta clinica sistemica a IXE.
    OBIETTIVO PRIMARIO
    L'obiettivo principale dello studio è valutare se le modifiche dei biomarcatori sinoviali nei surnatanti di colture e negli omogenati cellulari (dopo la somministrazione in vitro di IXE in saggi di diverse cellule / tessuti ottenuti da pazienti con PsA refrattaria) predicano la risposta clinica sistemica a IXE a 12 settimane.
    E.2.2Secondary objectives of the trial
    -To evaluate if relevant biomarkers modifications, after in vitro administration of IXE, relate to ultrasonography (US) response at 12 weeks;
    -To evaluate if baseline histopathological data (based on Krenn’s score (44,45), and number of CD20, CD3, CD68, CD117, CD31, evaluated using immunohistochemistry - IHC) relate to clinical response to systemic IXE at 12 weeks;
    -To evaluate if synovial biomarkers modifications, after in vitro administration of IXE, predict clinical response to systemic IXE at 24 weeks;
    -To deepen the synovial effect of IXE in synovial explant cultures and FLS/PBMCs co-cultures;
    -To establish if a concentration-dependent effect of IXE could be responsible of relevant results obtained;
    -To confirm safety of US-guided synovial biopsy procedures; to confirm reliability of US-guided synovial biopsies in collecting adequate synovial tissue to guarantee FLS cultures; to establish a reliable and reproducible method of co-culture system using PBMCs and FLS.
    Gli obiettivi secondari sono:
    - valutare se le modifiche dei biomarcatori, dopo la somministrazione in vitro di IXE, si correlano alla risposta ecografica a 12 settimane;
    - valutare se i dati istopatologici di base (basati sullo score di Krenn e il numero di CD20, CD3, CD68, CD117, CD31, valutati utilizzando immunoistochimica - IHC) sono correlati alla risposta clinica sistemica a IXE a 12 settimane;
    - valutare se le modifiche dei biomarcatori sinoviali, dopo somministrazione in vitro di IXE, predicono la risposta clinica sistemica a IXE a 24 settimane;
    - studiare l'effetto sinoviale di IXE nelle colture di espianti sinoviali e nelle co-colture FLS / PBMC;
    - stabilire se un effetto dipendente dalla concentrazione di IXE potrebbe essere responsabile dei risultati ottenuti;
    - confermare la sicurezza delle procedure di biopsia sinoviale ecoguidata;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Among patients routinely assessed, only patients with the following criteria will enter the study.
    3.3.1 INCLUSION CRITERIA:
    1. Confirmed diagnosis of PsA, according to an expert physician, and fulfilling the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria (55);
    2. Age greater than or equal to 18 years;
    3. Active disease (defined as 3 or more swollen joints AND 3 or more tender joints);
    4. Potential indication to (new) bDMARD therapy with IXE;
    5. Patients refractory to previous (at least 1) csDMARDs therapies (incomplete response, loss of efficacy or adverse events);
    6. One of the involved joints has to be appropriate for US-guided synovial biopsy;
    7. Patients must provide written informed consent.
    8. Oral prednisone at doses of =10 mg/day (stable for at least 4 weeks)
    9. No concomitant csDMARDs or concomitant background csDMARDs stable for at least 4 weeks.
    I pazienti verranno reclutati nel setting della ‘Refractory Clinic’ a Ferrara, un percorso clinico standardizzato in cui viene effettuata una stadiazione clinico-laboratoristico-radiologica ed istopatologica dell’artropatia infiammatoria cronica, prima di iniziare un nuovo trattamento con DMARDs al fallimento di un trattamento precedente, e presso l'Ambulatorio Reuma-Derma della Clinica Reumatologica di Udine. All’interno di tale programma clinico, le cellule dei pazienti verranno testate in vitro con IXE o con un veicolo di controllo (ad esempio, DMSO) secondo il protocollo di seguito sviluppato.
    I pazienti arruolati nello studio PRECISE devono soddisfare tutti i seguenti criteri di inclusione per essere eleggibili per questo studio:
    1. Diagnosi confermata di PsA, secondo un medico esperto, e conforme ai criteri di classificazione per l'artrite psoriasica (CASPAR);
    2. Età maggiore o uguale a 18 anni;
    3. Malattia attiva (definita come 3 o più articolazioni tumefatte e 3 o più articolazioni dolenti);
    4. Potenziale indicazione alla (nuova) terapia bDMARD con IXE;
    5. Pazienti refrattari a precedenti (almeno 1) terapie con DMARDs convenzionali (risposta incompleta, perdita di efficacia o eventi avversi);
    6. Una delle articolazioni coinvolte deve essere appropriata per la biopsia sinoviale ecoguidata;
    7. I pazienti devono fornire il consenso informato scritto.
    8. Prednisone orale a dosi =10 mg / die (stabile per almeno 4 settimane)
    9. Nessun DMARD convenzionale concomitante o DMARD di fondo concomitante stabile per almeno 4 settimane.
    E.4Principal exclusion criteria
    If a patient is positive for any of the following exclusion criteria, the patient will not be eligible for the study:
    1. Contraindication to start a new bDMARD treatment course;
    2. Previous treatment with bDMARDs (any) or tsDMARDs (any);
    3. Contraindication to US-guided synovial biopsy (e.g. uncontrolled haemostatic disorders, allergies to local anaesthetics);
    4. Patients with dementia or an altered mental status, which would preclude the understanding and rendering of informed consent.
    5. Known allergy or hypersensitivity to any biologic therapy.
    6. Administration of live attenuated vaccine(s) (LAVs) within 6 weeks of enrolment. Or intended use of LAV during the treatment period.
    7. Any history of malignancy in the last 5 years except for completely resected squamous or basal cell carcinoma of the skin.
    8. For women of childbearing potential: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3- months after discontinuation.
    9. Known immunodeficiency or patients immunocompromised to an extent that participation in the study would pose and unacceptable risk to the patient.
    10. Clinically relevant (chronic or acute) infections, including untreated (latent) tuberculosis,hepatitis B or C or HIV infections;
    11. Subjects with other autoimmune disease, e.g. Crohn's disease, Ulcerative colitis and Graves disease, except celiac disease and hypothyroidism which do not need to be excluded.
    3.3.2 CRITERI DI ESCLUSIONE
    1. Controindicazione ad iniziare un nuovo corso di trattamento con farmaco biologico;
    2. Precedente trattamento con DMARDs biologici o target sintetici;
    3. Controindicazione alla biopsia sinoviale ecoguidata (ad es. disturbi emostatici non controllati, allergie agli anestetici locali);
    4. Pazienti con demenza o uno stato mentale alterato, che precluderebbe la comprensione e la resa del consenso informato.
    5. Nota allergia o ipersensibilità a qualsiasi terapia biologica.
    6. Somministrazione di vaccini vivi attenuati entro 6 settimane dall'arruolamento.
    7. Qualsiasi storia di tumore maligno negli ultimi 5 anni ad eccezione del carcinoma a cellule squamose o basocellulari della pelle completamente resecato.
    8. Per le donne in età fertile: test di gravidanza positivo, attualmente allattamento al seno o riluttanza a utilizzare misure contraccettive efficaci per la durata dello studio e 3 mesi dopo l'interruzione.
    9. Immunodeficienza nota o pazienti immunocompromessi in una misura tale che la partecipazione allo studio rappresenterebbe un rischio inaccettabile per il paziente.
    10. infezioni clinicamente rilevanti (croniche o acute), compresa la tubercolosi (latente) non trattata, l'epatite B o C o le infezioni da HIV;
    11. Soggetti con altre malattie autoimmuni, ad es. Morbo di Crohn, colite ulcerosa e morbo di Graves, tranne la celiachia e l'ipotiroidismo che non devono essere esclusi.
    E.5 End points
    E.5.1Primary end point(s)
    The primary clinical endpoint of this study is response to treatment at T12, which will be primarily measured as ACR20 response (57).
    The primary laboratory endpoints are the sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV) and accuracy of the test in predicting the response to the treatment [Time point: T12].
    L'endpoint clinico primario di questo studio è la risposta al trattamento a T12, che sarà misurata principalmente come risposta ACR20.
    Gli endpoint primari di laboratorio sono la sensibilità, la specificità, i valori predittivi positivi (PPV), i valori predittivi negativi (NPV) e l'accuratezza del test nel predire la risposta al trattamento [Time point: T12].
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 WEEKS
    12 SETTIMANE
    E.5.2Secondary end point(s)
    - Patient-level ultrasonographic response according to multi-joint PsASon22 US score (55), measured as 20% variation in the inflammatory subscore [Time point: T12];
    - Joint level ultrasonographic response according to single-joint PsASon22 US score (55) [Time point: T12];
    - Other key clinical endpoints (ACR50, ACR70, DAPSA, MDA, HAQ-DI score; PGA, pain, PhGA, number of swollen/tender joints, BSA) [Time points: T12, T24];
    - Response to treatment according to ACR20 response (57) [Time point: T24];
    - Synovial biopsy-related adverse events [Time point: T0];
    - Drug-related adverse events and treatment emergent adverse events [Time point: T12, T24].
    Gli endpoint secondari sono:
    - Risposta ecografica in base al punteggio PsASon22 US, misurata come variazione del 20% nel subscore infiammatorio [Time point: T12];
    - Risposta ecografica a livello articolare secondo il punteggio PsASon22 monoarticolare [Time point: T12];
    - Altri endpoint clinici chiave (ACR50, ACR70, DAPSA, MDA, punteggio HAQ-DI; PGA, dolore, PhGA, numero di articolazioni gonfie / dolenti, BSA) [Punti temporali: T12, T24];
    - Risposta al trattamento secondo la risposta ACR20 [Time point: T24];
    - Eventi avversi correlati alla biopsia sinoviale [Time point: T0];
    - Eventi avversi correlati al farmaco ed eventi avversi emergenti dal trattamento [Time point: T12, T24].
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 WEEKS, 24 WEEKS
    12 SETTIMANE, 24 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 Yes
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    studio multicentrico a braccio singolo, in aperto, non randomizzato, non controllato.
    multicentre, proof-of-mechanism, single-arm, open label, non-randomized, uncontrolled clinical trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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
    when laboratory analysis are concluded
    a conclusione delle indagini di laboratorio
    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 months36
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months36
    E.8.9.2In all countries concerned by the trial days10
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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 proceed with the treatment if the drug is well tolerated because the treatment is on label for the disease
    proseguiranno la terapia se il farmaco sarà ben tollerato in quanto il trattamento è in indicazione per la patologia
    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 Decision2022-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-15
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 02 01:38:41 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA