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    Summary
    EudraCT Number:2022-001257-22
    Sponsor's Protocol Code Number:20210112
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-16
    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 number2022-001257-22
    A.3Full title of the trial
    Two Arm Bridging Study to Evaluate the Efficacy of Romiplostim in the Treatment of Non Asian Adult Severe Aplastic Anemia (SAA) Subjects who are Either Previously Untreated With Immunosuppressive Therapy (IST) or Refractory to IST
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Romiplostim in Treatment of Severe Aplastic Anemia in Non-Asian Adults Previously Untreated With or Refractory to Immunosuppressive Therapy
    A.4.1Sponsor's protocol code number20210112
    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 SponsorAmgen, Inc.
    B.1.3.4CountryUnited States
    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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen SAS
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street Address18-20 Quai du Point du Jour
    B.5.3.2Town/ cityBoulogne Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number0969 363 363
    B.5.6E-mailfr-medinfo@amgen.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 Yes
    D.2.1.1.1Trade name Nplate
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name NEORAL 100 mg, capsule molle
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS PHARMA S.A.S.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ATGAM 50 mg/mL, solution à diluer pour perfusion
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER HOLDING FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSolution for infusion (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOne ml contains horse anti-human T lymphocyte immunoglobulin (eATG) 50 mg
    D.3.9.3Other descriptive nameANIMAL TISSUE EXTRACTS
    D.3.9.4EV Substance CodeSUB72984
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name THYMOGLOBULINE 5 mg/ml, poudre pour solution pour perfusion
    D.2.1.1.2Name of the Marketing Authorisation holderGENZYME EUROPE B.V.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSolution for infusion (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN1 ml reconstituted solution contains 5 mg rabbit, anti-human thymocyte immunoglobulin.
    D.3.9.3Other descriptive nameANIMAL TISSUE EXTRACTS
    D.3.9.4EV Substance CodeSUB72984
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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
    Aplastic anemia (AA)
    E.1.1.1Medical condition in easily understood language
    Aplastic anemia (AA) is a condition that occurs when your body stops producing enough new blood cells
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002967
    E.1.2Term Aplastic anaemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10002968
    E.1.2Term Aplastic anaemia, unspecified
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10083893
    E.1.2Term Acquired aplastic anaemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032510
    E.1.2Term Other specified aplastic anaemias
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002969
    E.1.2Term Aplastic anemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002037
    E.1.2Term Anaemia aplastic
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002274
    E.1.2Term Anemia aplastic
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Arm 1: evaluate the efficacy of romiplostim and immunosuppressive therapy (IST) in adult non Asian severe aplastic anemia (SAA) subjects who are previously untreated with IST (1L)
    • Arm 2: evaluate the efficacy of romiplostim treatment in adult non Asian SAA subjects who are refractory to IST (2L+)
    E.2.2Secondary objectives of the trial
    • Arm 1: Describe efficacy for adult non-Asian SAA subjects who are previously untreated with IST (1L) to achieve a complete response (CR) or partial response (PR) following treatment with romiplostim and IST
    • Describe efficacy for non-Asian adult SAA subjects treated on the 2 study arms (1L/2L+) for decreasing the frequency of platelet and/or red blood cell (RBC) transfusions, or becoming platelet and/or RBC transfusion independent
    • Assess overall safety of romiplostim treatment for non-Asian subjects treated on the 2 study arms (1L/2L+)
    • Evaluate the bleeding status from baseline to week 14 in adult non-Asian SAA subjects in the 2 study arms (1L/2L+)
    • Evaluate the pharmacokinetics (PK) of romiplostim when it is administered subcutaneously (SC) in adult non-Asian SAA subjects in the 2 study arms (1L/2L+)
    • Evaluate the immunogenicity of romiplostim when it is administered SC in adult non-Asian SAA subjects in the 2 study arms (1L/2L+)

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has provided informed consent prior to initiation of any study specific activities/procedures or subject’s legally authorized representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator may compromise the ability of the subject to give written informed consent.
    2. Age more than or equal to 18 years at time of enrollment
    3. Diagnosis of severe AA or very severe AA confirmed by blood, bone marrow, and cytogenetic studies
    4. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 at screening
    5. Arm 1 only: considered to require new treatment with antithymocyte globulin and CsA
    6. Arm 2 only: refractory to at least 1 course of IST including horse or rabbit antithymocyte globulin; or ineligible for antithymocyte globulin treatment and refractory to CsA
    7. Arm 2 only: thrombocytopenia defined as a platelet count of less than equal to 30 x 10⁹/L
    E.4Principal exclusion criteria
    Disease-Related:
    1. Diagnosed as having congenital AA (Fanconi anemia, congenital dyskeratosis, etc,)
    Other Medical Conditions:
    2. History of other malignancy within the past 5 years, with the exceptions detailed in protocol
    3. Aplastic anemia with hemolytic paroxysmal nocturnal hemoglobinuria (hemolytic predominant is defined as lactate dehydrogenase [LDH] > 1.5 x the upper limit of site normal)
    4. Diagnosed as having acute myeloblastic leukemia (AML) or chronic myelomonocytic leukemia
    5. Concurrent thrombocytopenia of other etiologies (eg, MDS, ITP, cirrhosis)
    6. Current or past history of arterial or venous thrombus within 1 year prior to consent
    7. Concurrent active infection not adequately responding to appropriate therapy
    8. Current or past history of hypersensitivity to recombinant Escherichia coli-derived proteins
    9. Having grade 2 or higher bone marrow reticulin
    10. Positive for anti-human immunodeficiency virus (HIV) antibody at screening
    11. Receiving prophylactic or therapeutic treatment for hepatitis type B at screening
    examination (excluding prophylactic treatment for initiation of antithymocyte globulin treatment), or meeting any of the following items and having active hepatitis type B infection at screening:
    • Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).
    • Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.
    If any of the hepatitis B virus tests has an indeterminate result, confirmatory testing will be performed by an alternative method that is locally accepted.
    12. Positive hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
    Prior/Concomitant Therapy:
    13. Arm 1 only: Previously treated with antithymocyte globulin, CsA, or Alemtuzumab
    14. Previously treated with PEGylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), recombinant human TPO, romiplostim and other TPO-receptor agonist (eltrombopag, etc,)
    15. Planned HSCT during the study
    16. Systemic treatment with any of the following medication for the treatment of AA within 4 weeks before day 1, however, excluding their use as premedication:
    • anabolic steroids
    • corticosteroids
    Prior/Concurrent Clinical Study Experience:
    17. Currently receiving treatment in another investigational device or drug study, or less than 16 weeks (or 5-fold of the half-life [whichever is longer]) since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
    Diagnostic Assessments:
    18. Having blast cells > 2% in bone marrow at screening;
    19. Any of the following laboratory abnormalities at screening:
    • Total bilirubin (TBL): ≥ 1.5 times the upper limit of site normal
    • ALT: ≥ 3.0 times the upper limit of site normal
    • Aspartate aminotransferase (AST): ≥ 3.0 times the upper limit of site normal
    • Creatinine: > 2.0 mg/dL
    • Other abnormal laboratory values that are considered by the investigator to affect the completion of the study or evaluations
    20. History of chromosome aberrations discovered in bone marrow cells within 12 weeks prior to day 1. If the sponsor’s medical expert judged not to be problematic participation in this study, the patient can be enrolled.
    Other Exclusions:
    21 Subjects with Asian ethnicity defined as persons having origins in any of the original peoples of the Far East and Southeast Asia.
    22 Female subjects of childbearing potential unwilling to use protocol specified method of contraception , during treatment and until 3 months after investigational product(s) treatment.
    23 Female subjects who are breastfeeding or who plan to breastfeed while on study through 3 months after investigational product(s) treatment.
    24 Female subjects planning to become pregnant while on study through 3 months after investigational product(s) treatment.
    25 Female subjects of childbearing potential with a positive pregnancy test assessed at Screening by a highly sensitive serum pregnancy test.
    26 Subject has known sensitivity to any of the products or components to be administered during dosing.
    27 Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and investigator’s knowledge.
    28 History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion


    E.5 End points
    E.5.1Primary end point(s)
    week 14
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 14
    E.5.2Secondary end point(s)
    week 14
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 14
    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 No
    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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Information not present in EudraCT
    E.8.2.3.1Comparator description
    Cyclosporine A and Horse or Rabbit ATG
    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 concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Brazil
    United States
    France
    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
    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 months5
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days26
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If a potential subject is an illiterate, visually impaired, vulnerable population and does not have a legally acceptable representative, the investigator must provide an impartial witness to read the informed consent form. More info in France CSS
    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 6
    F.4.2.2In the whole clinical trial 16
    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)
    Upon permanent discontinuation from the study treatment for any reason, a site follow-up visit will be performed approximately 28 ( 3) days after the end of the last dose of investigational product and/or protocol-required therapies.
    A subject is considered to have completed the study if he/she has completed the study, including the last visit shown in the Schedule of Activities.
    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 Decision2023-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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