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    Summary
    EudraCT Number:2021-002570-54
    Sponsor's Protocol Code Number:D8231C00001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-11-10
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-002570-54
    A.3Full title of the trial
    A Modular Phase II, Open-label, Multicentre Study to Assess AZD4573 Efficacy and Safety as Monotherapy or in Combination with Anti-cancer Agents in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma or classical Hodgkin Lymphoma
    Étude modulaire de phase II, en ouvert, multicentrique, évaluant l’efficacité et la sécurité de l’AZD4573 en monothérapie ou en association avec des agents anti-cancéreux chez des patients atteints d’un lymphome périphérique à cellules T ou d’un lymphome de Hodgkin classique en rechute ou réfractaire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AZD4573 as Monotherapy or in Combination with Anti-cancer Agents in Patients with r/r PTCL or r/r cHL
    AZD4573 en monothérapie ou en association avec des agents anti-cancéreux chez des patients atteints de LTP r/r ou de LHc r/r
    A.4.1Sponsor's protocol code numberD8231C00001
    A.5.4Other Identifiers
    Name:IND numberNumber:156169
    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
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concorde Pike,
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE, 19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1877240 9479
    B.5.6E-mailInformation.Center@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 nameAZD4573
    D.3.2Product code AZD4573
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZD4573
    D.3.9.1CAS number 2057509-72-3
    D.3.9.2Current sponsor codeAZD4573
    D.3.9.3Other descriptive nameAZ13810325
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    - Relapsed/refractory Peripheral T-cell Lymphoma
    - Relapsed/refractory Classical Hodgkins Lymphoma
    - Lymphome périphérique à cellules T en rechute ou réfractaire (LTP r/r)
    - lymphome de Hodgkin classique en rechute ou réfractaire (LHc r/r)
    E.1.1.1Medical condition in easily understood language
    Cancer (lymphoma)
    Cancer (lymphome)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Module 1 :

    To assess the efficacy of AZD4573 by evaluation of objective response rate.
    Module 1 :

    Évaluer l’efficacité de l’AZD4573 d’après l’évaluation du taux de réponse objective
    E.2.2Secondary objectives of the trial
    Module 1:

    - To assess efficacy of AZD4573 by evaluation of tumour response and OS.
    - To assess the safety and tolerability of AZD4573.
    - To assess the plasma PK of AZD4573.
    Module 1 :

    - Évaluer l’efficacité de l'AZD4573 d’après l’évaluation du taux de réponse tumorale et de SG.
    - Évaluer la sécurité et la tolérance de l’AZD4573.
    - Évaluer la PK plasmatique de l’AZD4573.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participant must be at least 18 years of age inclusive at the time of signing the informed consent.
    - Participants who are diagnosed with one of the following, as defined by the World Health Organisation:
    • Peripheral T-cell Lymphoma
    • Classical Hodgkin Lymphoma
    - Eastern Cooperative Oncology Group performance status of ≤ 2.
    - Must have received at least 1 prior line of therapy for the treatment of current disease and have documented relapsed or refractory active disease requiring treatment, defined as:
    • Recurrence of disease after response to prior line(s) of therapy, or
    • Progressive disease after completion of or on the treatment regimen preceding entry into the study, or
    • Disease which did not achieve an objective response (CR or PR).
    -Prior lines of therapy:
    PTCL: Participants must have failed at least 1 prior therapy for the treatment of PTCL.
    • Non NK-PTCL (Cohort 1): Prior therapy must have included an alkylating agent and/or anthracycline. In addition, ALCL participants must have received BV as part of prior therapy.
    • NKTCL (Cohort 2): Prior treatment must have included a platinum agent and/or asparaginase.
    - cHL (Cohort 3): Participants must have failed at least 2 prior therapies for the treatment of cHL (including BV and anti-PD1) except where unable to receive BV or anti-PD1 due to neuropathy or autoimmune disease.
    - Presence of at least 1 radiographically measurable, FDG-avid lymphoma disease lesion > 1.5 cm (according to the Lugano criteria [Cheson et al 2014]).
    - Uric acid level < ULN at screening. If hyperuricaemia is present at screening, SoC therapy should be administered (including IV fluid and rasburicase or allopurinol) to reduce the uric acid levels to < ULN before the start of study intervention.
    - Willing and able to participate in all required evaluations and procedures in this study protocol including receiving IV administration of study drug and being admitted, if required, for at least 24 hours during study drug administration.
    - Fresh tumour tissue or archival tumour tissue must be confirmed to be available at screening.
    - Adequate haematologic function at screening.
    - Adequate haematologic function at screening.
    - PTCL Only: All participants with PTCL must be willing and able to provide mandatory baseline bone marrow aspirate and/or biopsy no older than 3 months, and agree to undergo post-treatment bone marrow biopsy when required to confirm response.
    - Participant âgé d’au moins 18 ans inclus au moment de la signature du formulaire de consentement éclairé.
    - Participants présentant un des diagnostics suivants, selon la définition de l’Organisation mondiale de la santé :
    • Lymphomes T périphériques
    • Lymphome hodgkinien classique
    - Score de performances ECOG (Eastern Cooperative Oncology Group) ≤ 2.
    - Antécédent d’au moins 1 ligne antérieure de traitement pour le traitement de la maladie en cours et documentation d’une atteinte active en rechute ou réfractaire nécessitant un traitement, selon la définition suivante :
    • Rechute de la maladie après une réponse à une ou plusieurs ligne(s) de traitement antérieure(s), ou
    • Progression de la maladie pendant ou après la fin du traitement précédant l’entrée dans l’étude, ou
    • Non-obtention d’une réponse objective (RC ou RP).
    - Lignes antérieures de traitement :
    LTP : Échec d’au moins 1 traitement antérieur pour le traitement du LTP.
    • LTP non NK (Cohorte 1) : Le traitement précédent devra avoir inclus un agent alkylant et/ou une anthracycline. En outre, les participants atteints de LAGC devront avoir reçu un traitement par BV dans le cadre du traitement antérieur.
    • LTPNK (Cohorte 2): Le traitement antérieur doit avoir inclus un agent asparaginase et/ou à base de platine.
    - LHc (Cohorte 3) : Les participants devront avoir été en échec thérapeutique pour au moins 2 traitements antérieurs pour le traitement d’un LHc (y compris BV et anti-PD1) sauf s’ils ont été dans l’incapacité de recevoir un traitement par BV ou anti-PD1 en raison d’une neuropathie ou d’une maladie auto-immune.
    - Présence d’au moins 1 lésion lymphomateuse FDG-avide mesurable radiographiquement > 1,5 cm (conformément aux critères de Lugano [Cheson et al 2014]).
    - Taux d’acide urique < LSN à la sélection. En présence d’une hyperuricémie à la sélection, un traitement de référence doit être administré (incluant liquides IV et rasburicase ou allopurinol) pour réduire les taux d’acide urique à des valeurs < LSN avant le début du traitement à l’étude.
    - Volonté et capacité de participer à toutes les évaluations et activités exigées dans ce protocole d’étude, y compris recevoir le médicament à l’étude par voie IV et être hospitalisé(e), si cela est nécessaire, pendant un maximum de 24 heures pendant l’administration du médicament à l’étude.
    - Confirmation de la disponibilité d’un échantillon de tissu tumoral frais ou archivé, à la sélection.
    - LTP uniquement : Tous les participants atteints de LTP devront avoir la volonté et la capacité de fournir des échantillons de biopsie et/ou ponction-aspiration médullaire, obligatoires à l’inclusion, de moins de 3 mois, et accepter d’effectuer une biopsie médullaire après le traitement, lorsque cela est nécessaire pour confirmer la réponse
    E.4Principal exclusion criteria
    - PTCL only: Presence of bulky disease (defined as largest lymphoma lesion ≥ 10 cm) or a LDH value > 3 x ULN.
    - PTCL only: Diagnosis of any of the following:
    • Lymphoblastic/precursor T-cell lymphoma or leukaemia
    • T-cell prolymphocytic leukaemia
    • T-cell large granular lymphocytic leukaemia
    • Cutaneous T-cell lymphoma (eg, primary cutaneous type ALCL, mycosis fungoide/Sezary syndrome).
    - With the exception of alopecia and neuropathy, presence of any unresolved non haematological toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment.
    - Presence of, or history of, CNS lymphoma, leptomeningeal disease, or spinal cord compression.
    - History of prior non-haematological malignancy except for the following:
    • Malignancy treated with curative intent and with no evidence of active disease present for more than 1 year prior to screening and felt to be at low risk for recurrence by treating physician.
    • Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer.
    • Adequately treated carcinoma in situ without current evidence of disease.
    - As judged by the investigator, any evidence of:
    • Severe or uncontrolled systemic disease (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]).
    • Current unstable or uncompensated respiratory or cardiac conditions.
    • Uncontrolled hypertension.
    • Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
    • IV anti-infective treatment within 1 week before first dose of study drug.
    - Known history of infection with HIV.
    - Serologic status reflecting active hepatitis B or C infection:
    • Participants who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative PCR result before enrolment. Those who are hepatitis B surface antigen positive or hepatitis B PCR-positive will be excluded.
    • Participants who are hepatitis C antibody positive will need to have a negative PCR result before enrolment. Those who are hepatitis C PCR-positive will be excluded.
    - Any of the following cardiac criteria:
    • Resting QT interval corrected using Fridericia’s formula (QTcF) ≥ 470 msec obtained from a single ECG.
    • Any clinically important abnormalities in rhythm (except for participants with a pacemaker in place), conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block).
    • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.
    - Documented confirmation and ongoing treatment of adrenal gland insufficiency or pancreatitis.
    - Undergone any of the following procedures or experienced any of the following conditions within 6 months prior to first dose:
    • Coronary artery bypass graft
    • Angioplasty
    • Vascular stent
    • Myocardial infarction
    • Angina pectoris
    • CHF (New York Heart Association Class ≥ 2)
    • Ventricular arrhythmias requiring continuous therapy
    • Atrial fibrillation, which is judged as uncontrolled by the treating physician
    • Haemorrhagic or thrombotic stroke, including transient ischemic attacks or any other CNS bleeding.
    - LTP uniquement : Présence d’une atteinte volumineuse (définie comme mesurant ≥ 10 cm, pour la plus grosse lésion lymphomateuse) ou d’un taux de LDH > 3 x LSN.
    - LTP uniquement : Présence d’un des diagnostics suivants :
    • Lymphome lymphoblastique/à précurseurs T ou leucémie
    • Leucémie prolymphocytaire à cellules T
    • Leucémie à grands lymphocytes granuleux T
    • Lymphome T cutané (par exemple, LAGC primitif de type cutané, mycose fongoïde/syndrome de Sézary).
    - À l’exception de l’alopécie et de la neutropénie, présence d’une toxicité non hématologique non résolue liée à un traitement antérieur supérieure à un Grade 1 CTCAE au moment du début du traitement à l’étude.
    - Présence ou antécédents de lymphome au niveau du SNC, d’une atteinte leptoméningée ou d’une compression médullaire.
    - Antécédents d’autres cancers non hématologiques, sauf :
    • Cancer traité avec intention curative et sans signe de maladie active présente depuis plus d’1 an au moins avant la sélection et considéré comme à faible risque de récidive par le médecin traitant.
    • Lentigo malin traité de manière appropriée, sans signe en cours de la maladie ou cancer cutané non mélanomateux contrôlé de manière appropriée.
    • Carcinome in situ traité de façon appropriée, sans signe actuel de présence de la maladie.
    - Selon le jugement de l’investigateur, tout signe de :
    • Maladie systémique sévère ou non contrôlée (par exemple, insuffisance hépatique sévère, pneumopathie interstitielle [pneumopathie parenchymateuse bilatérale, diffuse]).
    • Pathologies cardiaques ou respiratoires en cours, instables ou non compensées.
    • Hypertension artérielle non contrôlée.
    • Infection fongique, bactérienne, virale, ou toute autre infection, systémique active non contrôlée (définie comme présentant des signes/symptômes en cours liés à l’infection et sans amélioration, malgré une antibiothérapie appropriée ou tout autre traitement).
    • Traitement anti-infectieux par voie IV dans la semaine précédant la première dose de médicament à l’étude.
    - Antécédents connus d’infection par le virus de l’immunodéficience humaine (VIH).
    - Statut sérologique reflétant une infection active par le virus de l’hépatite B ou C :
    • Les participants ayant des résultats positifs pour la présence d’anticorps anti-noyau central du virus de l’hépatite B (anti-HBc) et des résultats négatifs pour l’antigène de surface devront avoir un résultat négatif à l’analyse par amplification en chaîne par polymérase (PCR) avant le recrutement. Les participants positifs pour l’antigène de surface du virus de l’hépatite B (VHB) ou positifs à l’analyse PCR du VHB seront exclus.
    • Les participants positifs pour les anticorps anti-virus de l’hépatite C devront avoir un résultat de PCR négatif avant le recrutement. Les patients ayant un résultat d’analyse PCR positif pour le virus de l’hépatite C seront exclus.
    - Présence de tout critère cardiaque suivant :
    • Intervalle QT de repos corrigé d’après la formule de Fridericia (QTcF) ≥ 470 msec issu d’un seul ECG.
    • Toute anomalie cliniquement importante du rythme (sauf pour les participants ayant un stimulateur cardiaque), de la conduction ou de la morphologie de l’ECG de repos (par exemple : bloc de branche gauche complet, bloc cardiaque du troisième degré).
    • Tout facteur augmentant le risque d’allongement de l’intervalle QTc ou le risque d’événements arythmiques, comme une insuffisance cardiaque, un syndrome du QT long congénital, des antécédents familiaux de syndrome du QT long ou de mort subite inexpliquée avant l’âge de 40 ans.
    - Confirmation documentée d’une insuffisance surrénale ou d’une pancréatite, et traitement en cours.
    - Toute intervention parmi les suivantes ou n’importe laquelle des pathologies suivantes dans les 6 mois avant la première dose :
    • Pontage coronaire
    • Angioplastie
    • Stent vasculaire
    • Infarctus du myocarde
    • Angor
    • Insuffisance cardiaque congestive (classe ≥ 2 selon la New York Heart Association)
    • Arythmie ventriculaire nécessitant un traitement continu
    • Fibrillation auriculaire, jugée non contrôlée par le médecin traitant
    • Accident vasculaire cérébral (AVC) hémorragique ou thrombotique, y compris accidents ischémique transitoires ou tout autre saignement dans le SNC.
    E.5 End points
    E.5.1Primary end point(s)
    ORR, defined as the proportion of participants who have a tumour response (CR and PR) based on Lugano response criteria for malignant lymphoma.
    TRO défini comme étant la proportion de participants ayant une réponse tumorale (RC et RP) mesuré en termes de critères de Lugano pour le lymphome malin
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Screening (Day -30 to Day -1) until disease progression or survival until death (approximately 6 months)
    De la sélection (Jour -30 à Jour -1) jusqu'à la progression de la madie ou le décès (environ 6 mois)
    E.5.2Secondary end point(s)
    - Endpoints based on Lugano response criteria for malignant lymphoma: CR rate, DoR, PFS.

    - OS

    - Plasma concentrations and derived PK parameters for AZD4573
    - Critères d'évaluatio nmesurés en termes de critères de Lugano pour le lymphome malin : RC, DdR, SSP.

    - SG

    - PK plasmatique de l’AZD4573
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Screening (Day -30 to Day -1) until disease progression or survival until death (approximately 6 months)
    De la sélection (Jour -30 à Jour -1) jusqu'à la progression de la madie ou le décès (environ 6 mois)
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    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
    Modular
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Australia
    Hong Kong
    Korea, Republic of
    Singapore
    Taiwan
    United States
    France
    Italy
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Dernière visite du dernier patient
    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 months10
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years2
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    With consent of participant’s legally authorised representative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 90
    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
    Aucun
    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 Decision2021-12-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-16
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