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   43801   clinical trials with a EudraCT protocol, of which   7272   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:2021-004398-30
    Sponsor's Protocol Code Number:ABX464-108
    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:2021-10-01
    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 number2021-004398-30
    A.3Full title of the trial
    A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis
    Studio di follow-up di fase II, in aperto, volto a valutare il profilo di sicurezza ed efficacia a lungo termine di ABX464 somministrato a 25 mg una volta al giorno in soggetti con colite ulcerosa attiva da moderata a grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis.
    Effetti di ABX464 durante il trattamento a lungo termine in pazienti con colite ulcerosa da moderata a grave.
    A.3.2Name or abbreviated title of the trial where available
    Long-term safety and efficacy follow-up of ABX464 in Ulcerative Colitis
    Follow-up di sicurezza ed efficacia a lungo termine di ABX464 nella colite ulcerosa
    A.4.1Sponsor's protocol code numberABX464-108
    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 SponsorAbivax
    B.1.3.4CountryFrance
    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 supportAbivax
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbivax
    B.5.2Functional name of contact pointVice President Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressRue de la Baume 5
    B.5.3.2Town/ cityParigi
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number0033153830961
    B.5.6E-mailPaul.Gineste@abivax.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 nameABX464
    D.3.2Product code [ABX464]
    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 INNABX464
    D.3.9.2Current sponsor codeABX464
    D.3.9.4EV Substance CodeSUB184487
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    Moderate to Severe Ulcerative Colitis
    Colite ulcerosa da moderata a grave
    E.1.1.1Medical condition in easily understood language
    In Ulcerative Colitis the lining of the colon becomes inflamed and develops tiny open sores that produce pus and mucous. This causes abdominal discomfort and frequent emptying of the colon (diarrhoea)
    Nella colite ulcerosa il rivestimento del colon si infiamma e sviluppa piccole ferite aperte che producono pus e muco. Questo causa fastidio addominale e frequente svuotamento del colon (diarrea)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the long-term safety of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.
    L'obiettivo principale dello studio è valutare la sicurezza a lungo termine di ABX464 somministrato a 25 mg una volta al giorno in soggetti con colite ulcerosa attiva da moderata a grave.
    E.2.2Secondary objectives of the trial
    1. To evaluate the long-term effect of ABX464 on clinical remission;
    2. To evaluate the long-term effect of ABX464 on endoscopic remission;
    3. To evaluate the long-term effect of ABX464 on clinical response;
    4. To evaluate the long-term effect of ABX464 on endoscopic improvement;
    5. To evaluate the long-term effect of ABX464 on inflammatory markers (C-Reactive Protein (CRP), Calprotectin;
    6. To evaluate the safety profile of ABX464;
    7. To evaluate the effect of ABX464 on miR-124 expression in total bloodat every timepoint defined in the schedule of assessment.

    Echocardiography objective:
    8. To evaluate the effect of ABX464 on cardiac function as assessed through echocardiograms.
    1. Valutare l'effetto a lungo termine di ABX464 sulla remissione clinica;
    2. Valutare l'effetto a lungo termine di ABX464 sulla remissione endoscopica;
    3. Valutare l'effetto a lungo termine di ABX464 sulla risposta clinica;
    4. Valutare l'effetto a lungo termine di ABX464 sul miglioramento endoscopico;
    5. Valutare l'effetto a lungo termine di ABX464 sui marcatori infiammatori (Proteina C-Reattiva (PCR), Calprotectina;
    6. Valutare il profilo di sicurezza di ABX464;
    7. Valutare l'effetto di ABX464 sull'espressione di miR-124 nel sangue totale ad ogni time point definito nel programma di valutazione;

    Obiettivo ecocardiografico:
    8. Valutare l'effetto di ABX464 sulla funzione cardiaca valutata mediante ecocardiogrammi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who previously completed the ABX464-102 or ABX464-104
    clinical studies;
    2. Subjects should be in endoscopic improvement with a rectal bleedingsub-score = 0 point at the end of treatment period in the previous study
    (ABX464-102 or ABX464-104). Endoscopic improvement is defined as: a Mayo endoscopic sub score of =1 ;
    3. Subjects able and willing to comply with study visits and procedures;
    4. Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures;
    5. Women of childbearing potential and men receiving the study treatment and their partners must agree to continue a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation,intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line
    with the preferred and usual lifestyle of the subject. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male subjects must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male subjects should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male subjects must not donate sperm as long as contraception is required. For the purpose of this protocol, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and untilbecoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and
    bilateral oophorectomy. A postmenopausal state is defined as no mensesfor 12 months without an alternative medical cause. A high follicle
    stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal
    contraception or hormonal replacement therapy. Finally, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
    1. Soggetti che hanno precedentemente completato gli studi clinici ABX464-102 o ABX464-104;
    2. I soggetti devono essere in miglioramento endoscopico con un sottopunteggio del sanguinamento rettale = 0 punti al termine del periodo di trattamento nello studio precedente (ABX464-102 o ABX464-104). Il miglioramento endoscopico è definito come sottopunteggio Mayo endoscopico di = 1;
    3. Soggetti capaci e disponibili a rispettare le visite e le procedure dello studio;
    4. I soggetti devono comprendere, firmare e datare il modulo di consenso informato volontario per iscritto in occasione della visita prima dell'esecuzione di eventuali procedure specifiche del protocollo;
    5. Le donne in età fertile e gli uomini che ricevono il trattamento dello studio e le loro partner devono acconsentire a continuare ad utilizzare un metodo
    contraccettivo altamente efficace durante lo studio e per i 6 mesi (180 giorni) dopo la fine o l'interruzione anticipata dello studio. Le donne devono
    essere chirurgicamente sterili oppure, se sono in età fertile, devono utilizzare un metodo contraccettivo altamente efficace. Le donne in età fertile (Women Of Childbearing Potential, WOCBP) accederanno allo studio dopo la conferma del ciclo mestruale e un test di gravidanza negativo. I metodi contraccettivi altamente efficaci includono astinenza effettiva, dispositivo intrauterino (DIU) o contraccezione ormonale finalizzata all'inibizione dell'ovulazione, sistema di rilascio ormonale intrauterino, legatura bilaterale delle tube, partner vasectomizzato. L'astinenza effettiva è definita come pratica in linea con lo stile di vita
    preferito e abituale del soggetto. In ogni caso di ritardo del ciclo mestruale (oltre un mese tra le mestruazioni) è richiesta la conferma dell'assenza di
    gravidanza. Questa raccomandazione si applica anche alle donne WOCBP con ciclo mestruale saltuario o irregolare. I soggetti di sesso femminile e maschile non devono pianificare una gravidanza durante la sperimentazione e nei 6 mesi successivi al completamento della loro partecipazione alla sperimentazione. Inoltre, i soggetti di sesso maschile devono utilizzare un preservativo durante la sperimentazione e nei 6 mesi (180 giorni) successivi al completamento della loro partecipazione allo studio. I soggetti di sesso maschile non devono donare sperma fintantoché sarà richiesta la contraccezione. Ai fini del presente protocollo, una donna è considerata in età fertile (WOCBP) successivamente al menarca e fino all'ingresso in post-menopausa, a meno che non sia permanentemente sterile. I metodi di sterilizzazione permanente includono isterectomia, salpingectomia bilaterale e ooforectomia bilaterale. Uno stato post-menopausale è definito come assenza del ciclo mestruale da 12 mesi senza una causa medica alternativa. Un livello elevato di ormone follicolo-stimolante (Follicle Stimulating Hormone, FSH) nel range della postmenopausa può essere utilizzato per confermare uno stato post-menopausale nelle donne che non utilizzano la contraccezione ormonale o una terapia ormonale sostitutiva. Infine, un uomo è considerato in età fertile a partire dalla pubertà, a meno che non sia stato reso definitivamente sterile mediante orchiectomia bilaterale.
    E.4Principal exclusion criteria
    1. Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study;
    2. Subjects with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study;
    3. Subjects who are participating or plan to participate in other investigational studies (other than induction study) during the study.
    1. Soggetti che hanno sviluppato una qualsiasi malattia/condizione importante o evidenza di una condizione clinica instabile (ad eccezione della CU) che, a giudizio dello sperimentatore, possa aumentare sostanzialmente il rischio per il partecipante qualora partecipi allo studio;
    2. Soggetti con qualsiasi altra condizione medica o psichiatrica acuta o cronica grave o anomalia di laboratorio o dell'elettrocardiogramma (ECG) che possaaumentare il rischio associato alla partecipazione allo studio o alla somministrazione del prodotto in sperimentazione o che possa interferire con l'interpretazione dei risultati dello studio e che, a giudizio dello sperimentatore, renderebbe il soggetto non idoneo all'ingresso in questo studio;
    3. Soggetti che partecipano o intendono partecipare ad altri studi sperimentali (diversi dallo studio di induzione) durante lo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Number of adverse events in ABX464 treated subjects.
    Numero di eventi avversi nei soggetti trattati con ABX464.
    E.5.1.1Timepoint(s) of evaluation of this end point
    LSLV
    LSLV
    E.5.2Secondary end point(s)
    1. Percentage of subjects reaching clinical remission at yearly visits.
    2. Percentage of subjects reaching endoscopic remission at yearly visits.
    3. Percentage of subjects reaching clinical response at yearly visits.
    4. Percentage of subjects reaching endoscopic improvement at yearly visits.
    5. The change from Baseline in fecal calprotectin and CRP levels.
    6a.Number and rate of all adverse events (AE) and causally-related adverse events, all SAE and causally-related SAEs, all AE of specific interest (AESI) and causally-related AESIs, classified by severity;
    6b. Incidence of adverse events leading to investigational medicinal product discontinuation;
    6c. The number of clinically-significant laboratory abnormalities.
    7. Change relative to baseline in miRNA-124 expression in total blood at every defined timepoints.

    Echocardiography endpoints:
    8a. Absolute (%) change from baseline echocardiogram of left ventricle ejection fraction (LVEF) as measured by 2- or 3-dimensional echocardiography;
    8b. Number of subjects with a clinically relevant reduction (change from baseline echocardiogram) of LVEF, defined as > 10% reduction (absolute
    percentage points) to a value < 50%;
    8c. Absolute (%) change in global longitudinal strain (GLS) from baseline echocardiogram;
    8d. Number of subjects with a relative percentage reduction in GLS by > 15% from the previous value;
    8e. Number of subjects with a reduction of LVEF > 10% (absolute percentage points) to a value = 50% with an accompanying fall in GLS >15%;
    8f. Number of subjects with reduction in LVEF by > 10% (absolute percentage points) to a value = 50%;
    8g. Changes from baseline echocardiography of other echocardiographic parameters as described in the Statistical Analysis Plan (SAP), including
    2- and 3-dimensional volumes, right ventricle size and systolic function and valve function.; 1. Percentuale di soggetti che raggiungono la remissione clinica alle visite annuali.
    2. Percentuale di soggetti che raggiungono la remissione endoscopica alle visite annuali.
    3. Percentuale di soggetti che raggiungono la risposta clinica alle visite annuali.
    4. Percentuale di soggetti che raggiungono il miglioramento endoscopico alle visite annuali.
    5. Variazione rispetto al basale nei livelli di calprotectina fecale e PCR.
    6a. Numero e tasso di tutti gli eventi avversi (Adverse Event, AE) ed eventi avversi causalmente correlati, di tutti gli eventi avversi gravi (Serious
    Adverse Event, SAE) ed eventi avversi gravi causalmente correlati, di tutti gli eventi avversi di interesse specifico (Adverse Event of Specific
    Interest, AESI) ed eventi avversi di interesse specifico causalmente correlati, classificati per gravità;
    6b. Incidenza di eventi avversi che comportano l'interruzione del medicinale in fase di sperimentazione;
    6c. Il numero di anomalie di laboratorio clinicamente significative.
    7. Variazione rispetto al basale nell'espressione di miRNA-124 nel sangue totale ad ogni time point definito.

    Endpoint ecocardiografici:
    8a. Variazione assoluta (%) dall'ecocardiogramma basale della frazione di eiezione ventricolare sinistra (FEVS) misurata mediante ecocardiografia bidimensionale o tridimensionale;
    8b. Numero di soggetti con una riduzione clinicamente rilevante (variazione dall'ecocardiogramma basale) della FEVS, definita come
    riduzione da un valore > 10% (punti percentuali assoluti) a un valore < 50%;
    8c. Variazione assoluta (%) della deformazione longitudinale globale (Global Longitudinal Strain, GLS) rispetto all'ecocardiogramma basale;
    8d. Numero di soggetti con relativa riduzione percentuale della GLS di un valore > 15% rispetto al valore precedente;
    8e. Numero di soggetti con una riduzione della FEVS da un valore > 10% (punti percentuali assoluti) ad un valore = 50% con un'associata
    riduzione della GLS > 15%;
    8f. Numero di soggetti con riduzione della FEVS da un valore > 10% (punti percentuali assoluti) ad un valore = 50%;
    8g. Variazioni rispetto all'ecocardiografia basale di altri parametri ecocardiografici come descritto nel Piano di analisi statistica (Statistical
    Analysis Plan, SAP), inclusi i volumi bidimensionali e tridimensionali, le dimensioni del ventricolo destro, la funzione sistolica e la funzione valvolare.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.-4. Yearly visits
    5. EOS
    6a.-6c. LSLV
    7. Yearly visits
    8a. EOS
    8b. LSLV
    8c. EOS
    8d.-8f. LSLV
    8g. EOS
    1.-4. Visite annuali
    5. EOS
    6a.-6c. LSLV
    7. Visite annuali
    8a. EOS
    8b. LSLV
    8c. EOS
    8d.-8f. LSLV
    8g. EOS
    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 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 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
    in aperto
    open
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Canada
    Serbia
    Ukraine
    Austria
    Belgium
    France
    Germany
    Hungary
    Italy
    Poland
    Slovakia
    Slovenia
    Spain
    Czechia
    E.8.7Trial has a data monitoring committee Yes
    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 years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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: 185
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 165
    F.4.2.2In the whole clinical trial 203
    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)
    None
    Nessuno
    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 Decision2021-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-21
    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA