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    EudraCT Number:2022-002441-18
    Sponsor's Protocol Code Number:D6582C00001
    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:2022-11-17
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2022-002441-18
    A.3Full title of the trial
    A Phase IIa Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of AZD4831, for 12-24 Weeks, in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD). (CRESCENDO)
    Studio di fase IIa, randomizzato, in doppio cieco, controllato verso placebo, a bracci paralleli, multicentrico per valutare l’efficacia e la sicurezza di AZD4831, per 12-24 settimane, nella broncopneumopatia cronica ostruttiva (BPCO) da moderata a grave. (CRESCENDO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    12 to 24 weeks of AZD4831 versus placebo for treatment of moderate to severe chronic obstructive pulmonary disease.
    Trattamento da 12 a 24 settimane della broncopneumopatia cronica ostruttiva da moderata a grave con AZD4831 verso placebo.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD6582C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05492877
    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 SponsorASTRAZENECA AB
    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 supportAstraZeneca AB
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number18772409479
    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 nameAZD4831 compressa da 5 mg rivestita con film
    D.3.2Product code [AZD4831]
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.1CAS number 1933460-19-5
    D.3.9.2Current sponsor codeAZD4831
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 placeboCoated tablet
    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
    Chronic Obstructive Pulmonary Disease (COPD).
    Broncopneumopatia Cronica Ostruttiva (BPCO).
    E.1.1.1Medical condition in easily understood language
    COPD is a serious lung conditions that cause the airways to narrow and become obstructive and inflamed, which in turn makes breathing difficult.
    La BPCO è una grave condizione polmonare che causa il restringimento delle vie aeree, che diventando ostruttive e infiammate rendono difficile la respirazione.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of AZD4831 as compared to placebo on the time to first COPDCompEx event.
    Valutare l'efficacia di AZD4831 rispetto al placebo sul tempo al primo evento COPDCompEx.
    E.2.2Secondary objectives of the trial
    - To assess the PK of AZD4831 in participants with moderate to severe COPD.
    - To evaluate the effect of AZD4831 as compared to placebo on the time to first moderate or severe COPD exacerbation.
    - To assess the effects of AZD4831 as compared to placebo on post-BD FEV1 in participants with moderate to severe COPD.
    - To assess the effect of AZD4831 compared with placebo on respiratory symptoms in participants with moderate to severe COPD.
    - To assess the effect of AZD4831 compared with placebo on disease impact participants with moderate to severe COPD.
    - Valutare la farmacocinetica di AZD4831 nei partecipanti con BPCO da moderata a grave.
    - Valutare l'effetto di AZD4831 rispetto al placebo sul tempo alla prima esacerbazione della BPCO moderata o grave.
    - Valutare gli effetti di AZD4831 rispetto al placebo sul FEV1 post-BD nei partecipanti con BPCO da moderata a grave.
    - Valutare l'effetto di AZD4831 rispetto al placebo sui sintomi respiratori nei partecipanti con BPCO da moderata a grave.
    - Valutare l'effetto di AZD4831 rispetto al placebo sui partecipanti all'impatto della malattia con BPCO da moderata a grave.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Title: Cough Monitoring Substudy
    Date and Version: Not applicable (part of the main protocol)
    Objective 1: To assess the effects of AZD4831 compared to placebo on change in cough frequency measured over a 24-hour period between baseline and Week 12.
    Objective 2: To investigate whether cough frequency is associated with lung function (eg. PEF, FEV1), cough/COPD symptom scores (eg. BCSS, CAT and Cough VAS) and sputum/blood biomarkers (eg. MPO concentration, neutrophil activation markers).

    It is specified that this substudy won't be implemented in Italy.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Titolo: Sottostudio sul monitoraggio della tosse
    Data e Versione: Non applicabile in quanto parte del protocollo di studio principale
    Obiettivo 1: Valutare l'effetto di AZD4831 rispetto al placebo sul cambiamento della frequenza della tosse misurata per un periodo di 24 ore fra il baseline e la settimana 12
    Obiettivo 2: Valutare se la frequenza della tosse sia associata alla funzionalità polmonare (es. PEF, FEV1), ai punteggi di tosse/BPCO sintomatica (es. BCSS, CAT e Cough VAS) e sputum/biomarcatori del sangue (es. concentrazione di MPO, marcatori di neutrofili attivati).

    Si intende precisare che tale sottostudio non verrà svolto in Italia.
    E.3Principal inclusion criteria
    1. Confirmed primary diagnosis of moderate to severe COPD as per FEV1/FVC < 0.7, and post-BD FEV1 = 25% predicted).
    2. Current or ex-smokers with a tobacco history of = 10 pack-years.
    3. High risk of exacerbations as defined by any one of the following: (a) A documented history of = 1 moderate or severe AECOPD requiring systemic corticosteroids and/or antibiotics for at least 3 days' duration (or 1 injection of Depot formulation), or hospitalisation for reason of AECOPD in the 24 months prior to screening or (b) Frequent productive cough, defined as a positive response to both of the following questions: • Over the past 3 months, I have coughed at least several days a week • Over the past 3 months, I have brought up phlegm (sputum) at least several days a week, or (c) Post-BD FEV1 < 50% predicted.
    4. Clinically stable and free from an exacerbation of COPD for 1 month prior to SV1 (screening) and prior to Day 1.
    5. Participants who are at least 70% compliant with each of the following: morning e-Diary, evening e-Diary, and PEF measurements during the 14 days preceding SV3 based on the e-Diary.
    6. Participants who have a documented stable regimen of triple therapy or dual therapy for = 3 months prior to enrolment. Triple therapy may consist of an appropriate combination of ICS + LABA + LAMA. Dual therapy consists of either inhaled ICS/LABA or LABA + LAMA where the treating physician deems the participant unsuitable for ICS (eg, blood eosinophil count = 100 cells/mL on 2 separate occasions, or on the basis of previous or perceived risk of significant AEs from ICS-based therapy, such as previous episodes of pneumonia or significant oral candidiasis).
    1. Diagnosi primaria confermata di BPCO da moderata a grave secondo FEV1/FVC < 0,7 e FEV1 post-BD = 25% del predetto.
    2. Fumatori attuali o ex fumatori con una storia di tabacco = 10 pacchetti di sigarette all'anno.
    3. Alto rischio di esacerbazioni come definito da uno qualsiasi dei seguenti elementi: (a) una storia documentata di = 1 AECOPD moderato o grave che ha richiesto corticosteroidi sistemici e/o antibiotici per una durata di almeno 3 giorni (o 1 iniezione di formulazione Depot) , o ricovero in ospedale per AECOPD nei 24 mesi precedenti lo screening o (b) tosse produttiva frequente, definita come risposta positiva a entrambe le seguenti domande: • Negli ultimi 3 mesi ho tossito almeno diversi giorni alla settimana • Negli ultimi 3 mesi, ho sollevato catarro (espettorato) almeno diversi giorni alla settimana, o (c) FEV1 post-BD < 50% del previsto.
    4. Clinicamente stabile e privo di esacerbazione della BPCO per 1 mese prima dell'SV1 (screening) e prima del giorno 1.
    5. Partecipanti che sono conformi almeno al 70% a ciascuno dei seguenti: e-Diary mattutino, e-Diary serale e misurazioni PEF durante i 14 giorni precedenti SV3 in base all'e-Diary.
    6. Partecipanti che hanno un regime stabile documentato di tripla terapia o doppia terapia per = 3 mesi prima dell'iscrizione. La tripla terapia può consistere in un'appropriata combinazione di ICS + LABA + LAMA. La doppia terapia consiste in ICS/LABA per via inalatoria o LABA + LAMA qualora il medico curante ritenga il partecipante non idoneo per ICS (p. es., conta degli eosinofili nel sangue = 100 cellule/mL in 2 occasioni separate, o sulla base del rischio eventi avversi da terapia basata su ICS, come precedenti episodi di polmonite o candidosi orale significativa).
    E.4Principal exclusion criteria
    1. Positive diagnostic lateral flow test for SARS-CoV-2 at SV1 or SV3. Participants will be eligible for rescreening = 2 weeks after a positive SARS-CoV-2 lateral flow test once COVID-19 symptoms have resolved, at the investigator's discretion.
    2. Current diagnosis of asthma or past diagnosis of asthma which persisted beyond the age of 25 years.
    3. Active malignancy requiring treatment (with the exception of basal cell or squamous cell carcinomas of the skin and stable prostate cancer).
    4. Evidence of untreated active TB: Participants currently receiving treatment for active TB may be considered after completion of an appropriate course of therapy.
    5. Change in smoking status in 12 weeks prior to enrolment or intention to change smoking status between enrolment and end of follow-up.
    6. Current diagnosis of hyperthyroidism, uncontrolled hypothyroidism (including but not limited to TSH = 10 mIU/mL), or any clinically significant thyroid disease.
    7. Participant who is going to start or finish intensive COPD rehabilitation program at anytime during study period. Participants can be recruited immediately following the completion of their COPD rehabilitation program.
    1. Test diagnostico positivo del flusso laterale per SARS-CoV-2 a SV1 o SV3. I partecipanti potranno essere sottoposti a un nuovo screening = 2 settimane dopo un test di flusso laterale positivo per SARS-CoV-2 una volta che i sintomi di COVID-19 si saranno risolti, a discrezione dello sperimentatore.
    2. Diagnosi attuale di asma o diagnosi pregressa di asma che persiste oltre l'età di 25 anni.
    3. Neoplasie maligne in fase attiva che richiedono un trattamento (ad eccezione dei carcinomi basocellulari o squamocellulari della pelle e del carcinoma prostatico stabile).
    4. Evidenza di TB attiva non trattata: i partecipanti che stanno attualmente ricevendo un trattamento per TB attiva possono essere presi in considerazione dopo il completamento di un ciclo di terapia appropriato.
    5. Modifica dello stato di fumatore nelle 12 settimane precedenti l'iscrizione o intenzione di modificare lo stato di fumatore tra l'iscrizione e la fine del follow-up.
    6. Diagnosi attuale di ipertiroidismo, ipotiroidismo non controllato (incluso ma non limitato a TSH = 10 mUI/mL) o qualsiasi malattia tiroidea clinicamente significativa.
    7. Partecipante che inizierà o finirà un programma di riabilitazione intensiva per la BPCO in qualsiasi momento durante il periodo di studio. I partecipanti possono essere reclutati immediatamente dopo il completamento del loro programma di riabilitazione della BPCO.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first COPDCompEx event. COPDCompEx events include changes in COPD symptoms, lung function testing, COPD exacerbations, study dropout due to lack of efficacy, and use of reliever medication.
    Tempo al primo evento COPDCompEx. Gli eventi COPDCompEx includono cambiamenti nei sintomi della BPCO, test di funzionalità polmonare, esacerbazioni della BPCO, abbandono dello studio per mancanza di efficacia e uso di farmaci al bisogno.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable as this is an event driven endpoint.
    Non applicabile in quanto si tratta di un endpoint guidato da eventi.
    E.5.2Secondary end point(s)
    Plasma AZD4831 concentration-time profiles during the intervention and follow-up periods, and PK numbers.
    - Time to first COPD exacerbation event.
    - Change from baseline in post-BD FEV1 after 12 weeks.
    - Change from baseline in E-RS:COPD, BCSS score, and cough VAS at Week 12 and Week 24.
    - Change from baseline in Total CAT measured in clinic at Week 12.
    - Safety and tolerability evaluations using AEs, SAEs, AESIs (skin reactions, including maculopapular rash, and infections, including pneumonia), vital sign measures, clinical laboratory assessments (clinical chemistry, haematology, and urinalysis), and ECG.
    - Sputum parameters including colour, differential cell counts, and markers of neutrophil activation and inflammation; MPO- and neutrophilrelated circulating biomarkers; Putative biomarkers of lung tissue destruction and COPD disease progression; Systemic biomarkers of cardiovascular comorbidities including fibrinogen, hsCRP, IL-6, and NTproBNP.
    - Average change from baseline to Week 12 in MPO activity normalised to MPO concentration in sputum.
    Profili di concentrazione-tempo nel plasma AZD4831 durante i periodi di intervento e follow-up e numeri di farmacocinetica.
    - Tempo al primo evento di esacerbazione della BPCO.
    - Modifica dal basale del FEV1 post-BD dopo 12 settimane.
    - Variazione rispetto al basale in E-RS:BPCO, punteggio BCSS e VAS della tosse alla settimana 12 e alla settimana 24.
    - Variazione rispetto al basale del CAT totale misurato in clinica alla settimana 12.
    - Valutazioni di sicurezza e tollerabilità mediante AE, SAE, AESI (reazioni cutanee, incluso rash maculopapulare e infezioni, inclusa la polmonite), misure dei segni vitali, valutazioni cliniche di laboratorio (chimica clinica, ematologia e analisi delle urine) ed ECG.
    - Parametri dell'espettorato tra cui colore, conta cellulare differenziale e marcatori di attivazione e infiammazione dei neutrofili; biomarcatori circolanti correlati a MPO e neutrofili; Presunti biomarcatori della distruzione del tessuto polmonare e della progressione della malattia della BPCO; Biomarcatori sistemici di comorbidità cardiovascolari tra cui fibrinogeno, hsCRP, IL-6 e NTproBNP.
    - Variazione media dal basale alla settimana 12 dell'attività MPO normalizzata alla concentrazione di MPO nell'espettorato.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - To assess the PK of AZD4831 in participants with moderate to severe COPD (timepoint not applicable).
    - To evaluate the effect of AZD4831 as compared to placebo on the time to first moderate or severe COPD exacerbation (timepoint not applicable).
    - To assess the effects of AZD4831 as compared to placebo on post-BD FEV1 in participants with moderate to severe COPD (week 12).
    - To assess the effect of AZD4831 compared with placebo on respiratory symptoms in participants with moderate to severe COPD (week 12).
    - To assess the effect of AZD4831 compared with placebo on disease impact participants with moderate to severe COPD (week 12).
    - Per valutare la farmacocinetica di AZD4831 nei partecipanti con BPCO da moderata a grave (timepoint non applicabile).
    - Per valutare l'effetto di AZD4831 rispetto al placebo sul tempo alla prima esacerbazione della BPCO moderata o grave (punto temporale non applicabile).
    - Per valutare gli effetti di AZD4831 rispetto al placebo sul FEV1 post-BD nei partecipanti con BPCO da moderata a grave (settimana 12).
    - Per valutare l'effetto di AZD4831 rispetto al placebo sui sintomi respiratori nei partecipanti con BPCO da moderata a grave (settimana 12).
    - Per valutare l'effetto di AZD4831 rispetto al placebo sui partecipanti all'impatto della malattia con BPCO da moderata a grave (settimana 12).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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. 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 EEA36
    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
    South Africa
    United States
    United Kingdom
    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
    A participant is considered to have completed the study if he/she has completed all phases of the study including SV8. The end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the
    protocol for the last participant in the study globally.
    Si considera che un partecipante abbia completato lo studio se ha completato tutte le fasi dello studio compreso SV8. La fine dello studio è definita come la data dell'ultima visita dell'ultimo partecipante allo studio o dell'ultima procedura programmata indicata nel protocollo per l'ultimo partecipante allo studio a livello globale.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days6
    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: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 123
    F.4.2.2In the whole clinical trial 288
    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)
    Return to Standard of Care (SoC).
    Ritorno allo Standard of Care (SoC).
    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 Decision2023-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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