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    Summary
    EudraCT Number:2020-004533-21
    Sponsor's Protocol Code Number:C1071003
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-02-19
    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 number2020-004533-21
    A.3Full title of the trial
    AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF PF-06863135 MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY
    ÉTUDE DE PHASE 2 EN OUVERT, MULTICENTRIQUE ET NON RANDOMISÉE PORTANT SUR LE PF-06863135 EN MONOTHÉRAPIE CHEZ DES PARTICIPANTS ATTEINTS D'UN MYÉLOME MULTIPLE QUI SONT RÉFRACTAIRES À AU MOINS UN INHIBITEUR DU PROTÉASOME, UN MÉDICAMENT IMMUNOMODULATEUR ET UN ANTICORPS ANTI-CD38
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of PF-06863135 Monotherapy in Participants With MM Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb
    Étude de phase 2 évaluant le PF-06863135 en monothérapie chez des participants atteints de MM réfractaire à au moins un IP, un IMID et un AcM anti-CD38
    A.4.1Sponsor's protocol code numberC1071003
    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 SponsorPfizer 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 supportPfizer, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer, Inc.
    B.5.2Functional name of contact pointClinicalTrials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1800 7181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 namePF-06863135
    D.3.2Product code PF-06863135
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06863135
    D.3.9.2Current sponsor codePF-06863135
    D.3.9.4EV Substance CodeSUB201694
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    MULTIPLE MYELOMA
    E.1.1.1Medical condition in easily understood language
    A hematological B-cell malignancy characterized by dysregulated proliferation of BM plasma cells.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of PF-06863135 in patients with no prior BCMA therapy (Cohort A) and prior BCMA therapy (cohort B).
    Déterminer l’efficacité du PF-06863135 chez des patients n’ayant jamais reçu de traitement anti-BCMA (cohorte A) et ayant reçu un traitement anti-BCMA (cohorte B).
    E.2.2Secondary objectives of the trial
    - To determine additional efficacy of PF-06863135 in Cohort A and Cohort B
    - To determine the safety and tolerability of PF-06863135
    - To evaluate the PK of PF-06863135
    - To evaluate the immunogenicity of PF-06863135
    - Déterminer l’efficacité supplémentaire du PF-06863135 dans la Cohorte A et la Cohorte B
    - Déterminer la sécurité d’emploi et la tolérance du PF-06863135
    - Évaluer la PK du PF-06863135
    - Évaluer l’immunogénicité du PF-06863135
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Age and Sex:
    1. Male or female participants age ≥18 years.

    Type of Participant and Disease Characteristics:
    2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
    3. Prior diagnosis of MM as defined according to IMWG criteria (Rajkumar et al, 2014).
    4. Measurable disease based on IMWG criteria as defined by at least 1 of the following:
    a. Serum M-protein >0.5 g/dL by SPEP
    b. Urinary M-protein excretion >200 mg/24 hours by UPEP
    c. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum
    immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65)
    5. Refractory to at least one IMiD.
    6. Refractory to at least one PI.
    7. Refractory to at least one anti-CD38 antibody.
    8. Relapsed/refractory to last anti-MM regimen.
    Note: Refractory is defined as having disease progression while on therapy or within
    60 days of last dose in any line, regardless of response.
    9. Cohort A: Has not received prior BCMA-directed therapy.
    Cohort B: Has received prior BCMA-directed ADC or BCMA-directed CAR T-cell
    therapy, either approved or investigational.
    10. ECOG performance status ≤2.
    11. LVEF ≥40% as determined by a MUGA scan or ECHO.
    12. Adequate hepatic function characterized by the following:
    a. Total bilirubin ≤2 x ULN (≤3 x ULN if documented Gilbert’s syndrome);
    b. AST ≤2.5 x ULN; and
    c. ALT ≤2.5 x ULN
    13. Adequate renal function defined by an estimated creatinine clearance ≥30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method).
    14. Adequate BM function characterized by the following:
    a. ANC ≥1.0 × 10^9/L;
    b. Platelets ≥25 × 10^9/L; and
    c. Hemoglobin ≥8 g/dL
    15. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1

    Informed Consent:
    16. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
    Les participants ne sont éligibles à l’inclusion dans l’étude que s’ils remplissent tous les critères suivants :
    Âge et sexe :
    1. Participants de sexe masculin ou féminin âgés de ≥ 18 ans.
    Type de patient et caractéristiques de la maladie :
    2. Participants qui acceptent et sont capables de se conformer aux visites programmées, au plan de traitement, aux analyses biologiques, aux aspects d’hygiène de vie et aux autres procédures de l’étude.
    3. Diagnostic antérieur de MM, défini selon les critères de l’IMWG (Rajkumar et al., 2014).
    4. Maladie mesurable selon les critères de l’IMWG, définie par au moins l’un des critères suivants :
    a. Taux de protéine M sérique > 0,5 g/dl par EPS
    b. Excrétion urinaire de la protéine M > 200 mg/24 heures par EPU
    c. Taux sérique des CLL d’immunoglobuline ≥ 10 mg/dl (≥ 100 mg/l) ET rapport CLL kappa/CLL lambda d’immunoglobulines sériques anormal (< 0,26 ou > 1,65)

    5. Réfractaire à au moins un IMID.
    6. Réfractaire à au moins un IP.
    7. Réfractaire à au moins un anticorps anti-CD38.
    8. En rechute/réfractaire au dernier schéma thérapeutique anti-MM.
    Remarque : le statut « réfractaire » est défini comme présentant une progression de la maladie sous traitement ou dans les 60 jours suivant l’administration la dernière dose de toute ligne de traitement, indépendamment de la réponse.
    9. Cohorte A : n’ayant pas reçu précédemment de traitement dirigé contre le BCMA. Cohorte B : ayant reçu précédemment un ADC dirigé contre le BCMA ou une thérapie par cellules CAR-T anti-BCMA, autorisé(e) ou expérimental(e).
    10. Indice de performance ECOG ≤ 2.
    11. FEVG ≥ 40 %, déterminée par un examen MUGA ou ECHO.
    12. Fonction hépatique adéquate possédant les caractéristiques suivantes :
    a. Taux de bilirubine totale ≤ 2 × LSN (≤ 3 × LSN en cas de syndrome de Gilbert documenté) ;
    b. Taux d’ASAT ≤ 2,5 × LSN ; et
    c. Taux d’ALAT ≤ 2,5 × LSN
    13. Fonction rénale adéquate, définie par une clairance de la créatinine estimée ≥ 30 ml/min (selon la formule de Cockcroft-Gault, par le recueil des urines de 24 heures pour la clairance de la créatinine, ou selon une méthode standard locale de l’établissement).
    14. Fonction médullaire adéquate possédant les caractéristiques suivantes :
    a. NAN ≥ 1,0 × 10^9/l ;
    b. Nombre de plaquettes ≥ 25 × 10^9/l ; et
    c. Taux d’hémoglobine ≥ 8 g/dl
    15. Effets aigus de tout traitement antérieur revenus au degré de sévérité initial ou à un grade CTCAE ≤ 1
    Consentement éclairé :
    16. Patient capable de donner un consentement éclairé signé, tel que décrit dans l’Annexe 1, incluant le respect des exigences et des restrictions mentionnées dans le document de consentement éclairé (DCE) et dans ce protocole.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical Conditions:
    1. Smoldering MM.
    2. Active Plasma cell leukemia.
    3. amyloidosis.
    4. Active GVHD.
    5. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:
    a. Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);
    b. Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
    c. Thromboembolic or cerebrovascular events (eg, transient ischemic attack,
    cerebrovascular accident, deep vein thrombosis or pulmonary embolism);
    d. Prolonged QT syndrome (or triplicate average QTcF >470 msec at screening).

    6. Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
    7. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
    8. Other surgical, medical or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.

    Prior/Concomitant Therapy:
    9. Previous treatment with an anti-BCMA bispecific antibody.

    Prior/Concurrent Clinical Study Experience:
    10. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).

    Other Exclusions:
    11. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
    Les participants seront exclus de l’étude s’ils remplissent l’un des critères suivants :
    Affections médicales :
    1. MM indolent.
    2. Leucémie à plasmocytes active.
    3. Amylose.
    4. MGVH active.
    5. Dysfonctionnement cardiovasculaire ou maladies cardiovasculaires cliniquement significatives, définies par la présence de l’un des facteurs suivants dans les 6 mois précédant l’inclusion :
    a. Infarctus du myocarde aigu ou syndromes coronariens aigus (angor instable, pontage aorto-coronarien, angioplastie coronaire ou pose d’une endoprothèse, épanchement péricardique symptomatique, par exemple) ;
    b. Arythmies cardiaques cliniquement significatives (fibrillation auriculaire non contrôlée ou tachycardie supraventriculaire paroxystique non contrôlée, par exemple) ;
    c. Événements thromboemboliques ou vasculaires cérébraux (accident ischémique transitoire, accident vasculaire cérébral, thrombose veineuse profonde ou embolie pulmonaire, par exemple) ;
    d. Syndrome du QT long (ou moyenne de 3 mesures du QTcF > 470 ms lors de la sélection).
    6. Infection active par le VHB, VHC, SARS-CoV-2, VIH, ou toute infection bactérienne, fongique ou virale, active, non contrôlée.
    7. Toute autre tumeur maligne active dans les 3 ans précédant l’inclusion, sauf s’il s’agit d’un cancer basocellulaire ou épidermoïde de la peau traité adéquatement, ou d’un carcinome in situ.
    8. Autres affections chirurgicales, médicales ou psychiatriques incluant des idées ou des comportements suicidaires récents (survenus au cours de l’année précédente) ou actuels, ou anomalies des analyses biologiques susceptibles d’accroître le risque associé à une participation à l’étude ou qui, de l’avis de l’investigateur, feraient du patient un candidat inapproprié pour cette étude.
    Traitement antérieur/concomitant :
    9. Traitement antérieur par un anticorps anti-BCMA bispécifique.
    Expérience d’études cliniques antérieures/concomitantes :
    10. Administration antérieure d’un médicament expérimental dans les 30 jours (ou dans un délai déterminé par les exigences locales) ou les 5 demi-vies précédant l’administration de la première dose de l’intervention à l’étude utilisée dans cette étude (selon l’éventualité la plus longue).
    Autres exclusions :
    11. Personnel du centre d’étude ou employés de Pfizer participant directement à la conduite de l’étude, personnel du centre supervisé par ailleurs par l’investigateur et les membres de leur famille.
    E.5 End points
    E.5.1Primary end point(s)
    ORR by BICR per IMWG
    TRO mesuré par l’ECIA selon l’IMWG
    E.5.1.1Timepoint(s) of evaluation of this end point
    In each of Cohort A and Cohort B, BOR will be assessed based on reported overall responses recorded at evaluation time points from the date of first dose until the first documentation of PD, death or start of new anticancer therapy, whichever occurs first.
    - OR will encompass confirmed sCR, CR, VGPR and PR.
    Dans chacune des cohortes A et B, la meilleure réponse globale (MRG) sera évaluée sur la base des réponses globales rapportées enregistrées aux points d’évaluation à partir de la date de l’administration de la première dose jusqu’à la première documentation de PM, au décès ou au début d’un nouveau traitement anticancéreux, selon la première éventualité.
    - La RG comprendra la RCs, la RC, la TBRP et la RP confirmées.
    E.5.2Secondary end point(s)
    To determine additional efficacy of PF-06863135 in Cohort A and Cohort B:
    - DOR by BICR and investigator per IMWG
    - CCRR by BICR and investigator per IMWG
    - ORR by investigator per IMWG
    - DOCCR by BICR and investigator per IMWG
    - PFS by BICR and investigator per IMWG
    - OS
    - TTR by BICR and investigator per IMWG
    - MRD negativity rate (central lab) per IMWG

    To determine the safety and tolerability ofPF-06863135
    - AEs and laboratory abnormalities as graded by NCI CTCAE v5.0.
    - Severity of CRS and ICANS assessed according to ASTCT criteria (Lee et al, 2019).

    To evaluate the PK of PF-06863135
    - Pre- and postdose concentrations of PF-06863135

    To evaluate the immunogenicity of PF-06863135
    - ADAs and NAbs against PF-06863135
    Déterminer l’efficacité supplémentaire du PF-06863135 dans la Cohorte A et la Cohorte B :
    - DR mesurée par un ECIA et l’investigateur selon l’IMWG
    - TRCC mesuré par un ECIA et l’investigateur selon l’IMWG
    - TRO mesuré par l’investigateur selon l’IMWG
    - DRCC mesurée par un ECIA et l’investigateur selon l’IMWG
    - SSP mesurée par un ECIA et l’investigateur selon l’IMWG
    - SG
    - DdR mesuré par un ECIA et l’investigateur selon l’IMWG
    - Taux de négativité de la MRM (laboratoire central) selon l’IMWG
    Déterminer la sécurité d’emploi et la tolérance du PF-06863135
    - EI et anomalies des analyses biologiques évalués selon les critères CTCAE v5.0 du NCI.
    - Sévérité du SRC et de l’ICANS évaluée conformément aux critères de l’ASTCT (Lee et al., 2019).
    Évaluer la PK du PF-06863135
    - Concentrations du PF-06863135 avant et après l’administration de la dose
    Évaluer l’immunogénicité du PF-06863135
    - AAM et AcN anti-PF-06863135
    E.5.2.1Timepoint(s) of evaluation of this end point
    Analyses of secondary efficacy endpoints will use the Safety Analysis Set. Please refer to section 9.4.3 of the protocol for a complete description of each secondary endpoint.
    Les analyses des critères d’évaluation secondaires de l’efficacité utiliseront la population d’analyse de la sécurité d’emploi. Veuillez vous reporter à la section 9.4.3 du protocole pour une description complète de chaque critère d’évaluation secondaire.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Canada
    Japan
    United States
    Belgium
    France
    Germany
    Poland
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days24
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 150
    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
    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 Decision2021-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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