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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   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).

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    Summary
    EudraCT Number:2022-002441-18
    Sponsor's Protocol Code Number:D6582C00001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-30
    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 ConcernedSpain - AEMPS
    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)
    Ensayo de fase IIa aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, multicéntrico para evaluar la eficacia y seguridad de AZD4831, durante 12-24 semanas, en la enfermedad pulmonar obstructiva crónica (EPOC) de moderada a grave.
    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
    De 12 a 24 semanas de AZD4831 en comparación con el placebo para el tratamiento de la enfermedad pulmonar obstructiva crónica de moderada a grave
    A.3.2Name or abbreviated title of the trial where available
    CRESCENDO
    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.1.3.4CountrySweden
    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.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte, Edificio Álamo
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034900200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.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 nameAZD4831 film-coated tablet 5 mg
    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.3.8INN - Proposed INNNot available
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 placeboFilm-coated 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)
    Enfermedad Pulmonar Obstructiva Crónica (EPOC)
    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 EPOC es una afección pulmonar grave que provoca que las vías aéreas se estrechen al obstruirse e inflamarse, dificultando la respiración
    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.
    Evaluar el efecto de AZD4831 en comparación con el placebo en el tiempo hasta el primer acontecimiento de 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.
    - Evaluar la farmacocinética de AZD4831 en participantes con EPOC de moderada a grave.
    - Evaluar el efecto de AZD4831 en comparación con placebo en lo que respecta al tiempo hasta la primera exacerbación moderada o grave de la EPOC
    -Evaluar los efectos de AZD4831 en comparación con el placebo sobre el FEV1 después del BD en participantes con EPOC de moderada a grave
    -Evaluar el efecto de AZD4831 en comparación con el placebo sobre los síntomas respiratorios en participantes con EPOC de moderada a grave
    - Evaluar el efecto de AZD4831 en comparación con el placebo sobre el impacto de la enfermedad en participantes con EPOC de moderada 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
    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).
    Subestudio de monitorización de la tos
    Fecha y Versión: No aplicable (parte del protocolo principal)
    Objetivo 1: Evaluar los efectos de AZD4831 en comparación con placebo sobre el cambio en la frecuencia de la tos medido durante un periodo de 24 horas entre la basal y la semana 12.
    Objectivo 2: Investigar si la frecuencia media de la tos está asociada a la función pulmonar (p. ej., flujo espiratorio máximo [PEF] o FEV1), las puntuaciones de los síntomas de tos/EPOC (p. ej., disnea, escala de tos y esputo [BCSS], prueba de evaluación de la EPOC [CAT] y escala visual analógica de la tos [EVA]) y los biomarcadores de esputo/sangre (p. ej., concentración de MPO, marcadores de activación de neutrófilos)
    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. Diagnóstico primario confirmado de EPOC de moderada a grave por FEV1/FVC <0,7 y FEV1 después del BD ≥25 % previsto)
    2. Fumadores o ex-fumadores con antecedentes de tabaquismo ≥10 paquetes-año
    3. Con alto riesgo de exacerbación definido por alguna de lo siguiente:
    (a) Antecedentes confirmados de ≥1 EAEPOC moderada o grave que requiere corticoesteroides sistémicos y/o antibióticos durante al menos 3 días de duración (o 1 inyección de formulación de liberación prolongada) u hospitalización por EAEPOC en los 24 meses anteriores a la selección
    (b) Tiene tos productiva frecuente definida como una respuesta positiva a las dos siguientes preguntas:
    • Durante los últimos 3 meses, he tosido al menos varios días a la semana.
    • Durante los últimos 3 meses, he expectorado al menos varios días a la semana, o
    (c) FEV después del BD <50 % previsto.
    4. Clínicamente estables y que no hayan sufrido ninguna exacerbación de la EPOC durante 1 mes antes de la VE1 (selección) y antes del día 1.
    5. Participantes que cumplan al menos el 70 % de los siguientes requisitos: diario electrónico matutino, diario electrónico nocturno y mediciones de PEF durante los 14 días anteriores a la VE3 según el diario electrónico.
    6. Participantes que tengan una pauta posológica estable confirmada de tratamiento triple o doble durante ≥3 meses antes de la inclusión. El tratamiento triple puede consistir en una combinación adecuada de ICS + LABA + LAMA. El tratamiento doble consiste en ICS + LABA o LABA + LAMA cuando el médico responsable del tratamiento considere que el participante no es adecuado para recibir ICS (p ej., recuento de eosinófilos en sangre ≤100 células/ml en 2 ocasiones distintas, o si hay riesgo previo o percibido por AAs significativos del tratamiento a partir de ICS, como episodios anteriores de neumonía o candidiasis oral 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. Prueba de flujo lateral diagnóstica positiva para el SARS-CoV-2 en VE1 o VE3. Los participantes serán elegibles para la repetición de la selección ≥2 semanas después de una prueba de flujo lateral de SARS-CoV-2 positiva una vez que los síntomas de la COVID-19 se hayan resuelto, a criterio del investigador
    2. Diagnóstico actual de asma o diagnóstico anterior de asma que haya persistido después de los 25 años
    3. Neoplasia maligna activa que requiere tratamiento (con la excepción de los carcinomas basocelulares o de células escamosas de la piel y del cáncer de próstata estable)
    4. Indicios de tuberculosis activa no tratada:
    Los participantes que actualmente reciben tratamiento para la tuberculosis activa se podrán tener en cuenta después de completar un tratamiento adecuado
    5. Cambio en el estado de tabaquismo en las 12 semanas anteriores a la inclusión o intención de cambiar el estado de tabaquismo entre la inclusión y el final del seguimiento
    6. Diagnóstico actual de hipertiroidismo, hipotiroidismo no controlado (incluidos, entre otros, TSH ≥10 mIU/ml) o cualquier enfermedad tiroidea clínicamente significativa
    7. Participante que va a comenzar o terminar el programa de rehabilitación intensiva de EPOC en cualquier momento durante el periodo del ensayo. Se puede incluir a los participantes inmediatamente después de que acabe su programa de rehabilitación de EPOC
    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.
    Tiempo hasta el primer evento COPDCompEx. Los eventos de COPDCompEx incluyen cambios en los síntomas de la EPOC, pruebas de función pulmonar, exacerbaciones de la EPOC, abandonos del estudio debido a la falta de eficacia y uso de medicación de rescate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable as this is an event driven endpoint.
    No aplicable, ya que es en función de los acontecimientos.
    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 neutrophil- related circulating biomarkers; Putative biomarkers of lung tissue destruction and COPD disease progression; Systemic biomarkers of cardiovascular comorbidities including fibrinogen, hsCRP, IL-6, and NT-proBNP.
    - Average change from baseline to Week 12 in MPO activity normalised to MPO concentration in sputum.
    - Perfiles de concentración-tiempo de AZD4831 en plasma durante los periodos de intervención y seguimiento, y parámetros farmacocinéticos
    - Tiempo hasta el primer acontecimiento de exacerbación de la EPOC
    - Cambio desde la basal en el FEV1 después del BD al cabo de 12 semanas
    - Cambio desde la basal en la E‑RS: EPOC, la puntuación BCSS y la EVA de la tos en las semanas 12 y 24
    - Cambio desde la basal en el total de CAT medida en el centro en la semana 12
    - Evaluaciones de seguridad y tolerabilidad mediante AA, AAG, AAEI (reacciones cutáneas, incluida la erupción maculopapular, e infecciones, incluida la neumonía), mediciones de las constantes vitales, evaluaciones analíticas (bioquímica clínica, hematología y análisis de orina) y ECG
    - Parámetros de esputo que incluyen color, recuento diferencial de células y marcadores de activación e inflamación de neutrófilos; Biomarcadores circulantes relacionados con MPO y neutrófilos; Biomarcadores putativos de destrucción de tejido pulmonar y progresión de la enfermedad de EPOC; Biomarcadores sistémicos de comorbilidades cardiovasculares, incluidos fibrinógeno, hsCRP, IL-6 y NT-proBNP
    - Cambio promedio desde el inicio hasta la semana 12 en la actividad de MPO normalizada a la concentración de MPO en el esputo
    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)
    - Para evaluar la farmacocinética de AZD4831 en participantes con EPOC moderada a grave (tiempo no aplicable)
    - Para evaluar el efecto de AZD4831 en comparación con placebo en lo que respecta al tiempo hasta la primera exacerbación moderada o grave de la EPOC (tiempo no aplicable)
    - Para evaluar los efectos de AZD4831 en comparación con el placebo sobre el FEV1 después del BD en participantes con EPOC de moderada a grave (semana 12)
    - Para evaluar el efecto de AZD4831 en comparación con el placebo sobre los síntomas respiratorios en participantes con EPOC de moderada a grave (semana 12)
    - Para evaluar el efecto de AZD4831 en comparación con el placebo sobre el impacto de la enfermedad en participantes con EPOC de moderada a grave (semana 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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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 No
    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
    South Africa
    United States
    Poland
    Bulgaria
    Netherlands
    Spain
    Germany
    Italy
    Denmark
    Turkey
    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.
    Se considera que un participante ha completado el estudio si ha completó todas las fases del estudio incluyendo VE8.
    El final del estudio se define como la fecha de la última visita del último participante en el estudio o último procedimiento programado que se muestra en el protocolo para el último participante en el estudio a nivel mundial.
    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 months3
    E.8.9.1In the Member State concerned days24
    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.
    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 Decision2022-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
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