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    Summary
    EudraCT Number:2018-004536-29
    Sponsor's Protocol Code Number:CHUBX2017/44
    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:2019-05-03
    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 number2018-004536-29
    A.3Full title of the trial
    Efficacy and tolerance of the association of MTX and phototherapy versus phototherapy in adults with progressive vitiligo : a randomized double blind prospective study (METVI)
    Efficacité et tolérance de la combinaison méthotrexate plus photothérapie et de la photothérapie seule chez les patients atteints d’un vitiligo progressif: étude de phase 2 (METVI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Association of Metothrexate and Phototherapy in progressive vitiligo.
    Association du Métothrexate et de la Photothérapie dans le vitiligo progressif.
    A.3.2Name or abbreviated title of the trial where available
    METVI
    METVI
    A.4.1Sponsor's protocol code numberCHUBX2017/44
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04237103
    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 SponsorCHU de Bordeaux
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFrench Ministery of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Bordeaux
    B.5.2Functional name of contact pointProject manager
    B.5.3 Address:
    B.5.3.1Street Address12 rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33400
    B.5.3.4CountryFrance
    B.5.4Telephone number33557821158
    B.5.5Fax number33556794926
    B.5.6E-mailfrederic.perry@chu-bordeaux.fr
    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 IMETH 10mg
    D.2.1.1.2Name of the Marketing Authorisation holderNordic Pharma
    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, hard
    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 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.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 IMETH 2.5mg
    D.2.1.1.2Name of the Marketing Authorisation holderNordic Pharma
    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, hard
    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 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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Progressive vitiligo
    Vitiligo progressif
    E.1.1.1Medical condition in easily understood language
    Vitiligo with new lesions or extension of old lesions during the last 6 months
    Vitiligo avec de nouvelles lésions ou l’extension d’anciennes lésions durant les 6 derniers mois
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10047642
    E.1.2Term Vitiligo
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Variation in percentage of repigmented surface area 8 months after inclusion, by using the VASI score.
    Evaluer du pourcentage de surface repigmentée à 8 mois grâce au score VASI dans le groupe expérimental recevant MTX + photothérapie UVB TL01
    E.2.2Secondary objectives of the trial
    • Variation in percentage of repigmented surface area 4 months after inclusion, by using the VASI score
    • Following criteria will be evaluated 4 and 8 months after inclusion
    - Analysis of clinical and biological tolerance of MTX and phototherapy
    - Variation of the score Vitiligo European Task Force (VETF) at month 8 :
    - Variation in percentage of the Vitiligo Extent Score (VES) at month 8.
    - Variation in percentage of the F-VASI at month 8
    - Variation of the score of the Dermatology Life Quality Index (DLQI) measured
    - Variation of the score of the Skindex 29.
    - Variation of the score of the Vitiligo Impact Scale (VIP).
    - Variation of blood and skin inflammatory markers.
    - Evaluer la sécurité clinique et biologique de l’association MTX (PO à 15mg/semaine) + UVB TL01.
    - Estimer le pourcentage de surface repigmentée dans le groupe de calibration (Placebo + UVB TL01) grâce au score VASI à M8.
    - Estimer le pourcentage de surface repigmentée en utilisant les scores VETF et VES.
    - Estimer la variation du pourcentage du score du F-VASI à M8
    - Evaluer l’amélioration du score de qualité de vie et du fardeau de la maladie mesurée à l’aide du Dermatology Life Quality Index (DLQI), des questionnaires Vitiligo Impact Patient scale (VIPs) et SkinDex29.
    - Evaluer la réduction des marqueurs inflammatoires (sanguins et cutanés).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject male or female age over 18 years old
    - Diagnosis of non-segmental (symmetrical) vitiligo with body surface area ≥10%
    - Active non-segmental vitiligo defined by
    Non-segmental vitiligo with new patches or extension of old lesions during the last 6 months AND
    Presence of hypochromic aspect under Wood’s lamp examination and/or perifollicular hypopigmentation under Wood’s lamp examination.
    - Signed informed consent document
    - Male patients agreeing to use a reliable method of birth control during the study i. e. preservative and for at least 6 months following the last dose of investigational product, the patient's partner treated by methotrexate must be notified of the teratogenic risk of methotrexate and should be under effective contraception throughout the study and for at least 6 months following the last dose of investigational product.
    - Women of childbearing potential who are negatively tested for pregnancy and agree to use a reliable method of birth control (every month) or remain abstinent during the study and for at least 6 months following the last dose of investigational product. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring
    - Patient registered to the French Social Security
    - Patients âgés de 18 ans à 75 ans
    - Patients atteints d’un vitiligo progressif défini par :
    ● vitiligo non segmentaire avec de nouvelles lésions ou l’extension d’anciennes lésions durant les 6 derniers mois ET
    ● Présence de lésions « trichromes » ou hypochromiques en lumière de WOOD
    - Patients présentant une surface cutanée atteinte >10%
    - Consentement écrit, libre, éclairé et signé par le patient et l’investigateur (avant tout examen nécessité par l’étude)
    - Sujet affilié ou bénéficiaire d’un régime de sécurité sociale.
    - Méthode de contraception efficace pour les hommes, c’est-à-dire utilisation du préservatif, pendant toute la durée de la prise du MTX ou du placebo et pendant les 6 mois après sa dernière prise. La partenaire du patient prenant du MTX doit être avertie des risques tératogènes du méthotrexate et doit être sous contraception efficace tout au long de l’étude et pendant 6 mois après la dernière prise de traitement.
    - Après un test de grossesse (β-HCG) négatif à l’inclusion, méthode de contraception efficace pour les femmes en âge de procréer (contraceptifs oraux ou en patch, dispositif intra-utérin, anneau vaginal) pendant toute la durée de la prise du médicament à l’étude et pendant 6 mois après la dernière prise.
    E.4Principal exclusion criteria
    - Segmental or mixed vitiligo
    - Patients who have known active liver disease (with the exception of a simple liver steatosis, transaminases and/or alkaline phosphatases > 2 ULM ) or history of liver disease in the past 2 years, whatever the related diagnosis but which could interfere with MTX safety and according to the summary of the SmPC.
    - Intake of restricted medications (cf section VIII.5.) or other drugs considered likely to interfere with the safe conduct of the study, as assessed by the investigator and according to the Summary of the Product Characteristics (SmPC), including any drug intakes that could interfere with methotrexate metabolism or that could enhance liver and /or hematologic toxicity and according to the SmPC
    - Patient with evidence or positive test for HIV, Hepatitis C virus, Hepatitis B virus (patients who are negative for hepatitis B surface antigen but positive for anti-hepatitis B anti body (HBsAb+ and HBcAb+) and negative for serum HBV DNA may participate in the study
    - High alcohol intake defined as more than 60 g of daily intake (approx daily intake of 0.5 l of wine or equivalent),
    - Patients who have a known allergy or hypersensitivity to MTX
    - Patients who have a known serious adverse event to MTX prior to the trial leading to MTX discontinuation in the past
    - Presence of significant hematologic or renal disorder or abnormal laboratory values at screening that, in the opinion of the investigator is associated with an unacceptable risk to the patient to participate in the study
    - Clinical laboratory test results at screening that are outside a normal reference rating for the population and are considered clinically significant, or/and have any of the following specific abnormalities:
    -Total white blood cell count <3G/L
    -Neutrophil count < 1.5 G/l
    -Lymphocytes count < 0.5G/l
    -Platelet count < 100 G/l
    -Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>3 times the upper limit of normal (ULM)
    -Hemoglobin <8.5g/dL (85.0 g/L)
    -Creatinine clearance <40ml/min (Cockcroft formula)
    - For women: pregnant or breast feeding
    - Patients who have an active or serious infection or history of infections (bacterial, viral, fungal or mycobacteria), requiring hospitalization or intra venous anti-infectives infusion within 4 weeks prior to the baseline,
    - Patients who have primary or secondary active immunodeficiency
    - Patients who had live vaccine administration within 4 weeks prior to baseline
    - Patients who had already been treated by at least 250 sessions of phototherapy
    - Patients who have any current or active cancer (with the exception of patient with successfully treated with in situ cervix carcinoma)

    - Patients who had history of malignancy within 5 years prior to the trial that could contraindicate the use of an immunosuppressant
    - Patients who will not be available for protocol which require study visits or procedures
    - Patients who is not affiliated to the French Social Security system
    - Patients unable to give informed consent and/or comply with all required study procedures
    - Vitiligo segmentaire ou mixte
    - Utilisation de traitement pour le vitiligo (topiques : dermocorticoïde-inhibiteur de la calcineurine-photothérapie) durant les 4 dernières semaines
    - Utilisation de traitement immuno-modulateur durant les 4 dernières semaines.
    - Patient(e) connu(e) pour avoir une maladie hépatique active (à l’exception d’une simple stéatose hépatique, et/ou de transaminases et/ou de phosphatases alcalines < 2 la valeur normale supérieure) ou connu pour avoir eu une histoire de maladie hépatique dans les 2 ans avant l’inclusion quel que soit le diagnostic susceptible d’interférer avec le MTX
    - Patient(e) traité(e) par un/des médicament(s) susceptible(s) d’interférer avec le métabolisme du MTX ou susceptible(s) de majorer la toxicité hématologique et ou hépatique du MTX et selon les RCP du médicament à l’étude
    - Patient(e) avec une sérologie ou des données biologiques témoignant d’une infection active et réplicative pour le HIV, les virus de l’hépatite C, de l’hépatite B (mais les patients avec sérologie négative pour les ag de surface de l’hépatite B mais positive pour les anticorps anti Hépatite B - HBsAc+ et HBcAc+ et avec une virémie négative HBV DNA peuvent participer à l’étude).
    - Patient(e) présentant une consommation excessive d’alcool, correspondant à une consommation minimale de 60g par jour (approximativement 0,5 litre de vin ou équivalent)
    - Patient(e) présentant une allergie ou hypersensibilité connue au méthotrexate
    - Patient(e) ayant déjà présenté des effets secondaires graves au cours d’un traitement précédent par MTX, ayant pu motiver son arrêt et contre indiquant une nouvelle prise
    - Patient(e) présentant des anomalies hématologiques, des anomalies biologiques rénales ou de toutes autres anomalies biologiques à la visite de sélection, qui dans l’opinion de l’investigateur, seraient associées à un risque inacceptable pour le patient s’il participait à l’étude ou pourraient interférer avec l’interprétation des données.
    - Patient(e) présentant des anomalies biologiques au screening au-delà des valeurs considérées comme normales et considérées comme cliniquement significatives et /ou une anomalie des biologiques suivantes :
    o Globules blancs < 3G/L
    o Neutrophiles < 1,5 G/l
    o Lymphocytes < 0,5 G/l
    o Plaquettes < 100 G/l
    o Aspartate aminotransférase (AST) ou alanine aminotransférase (ALT)> 3 fois les valeurs normales
    o Hémoglobine < 8,5 g/dL (85.0 g/L)
    o Clairance créatinine < 40 ml/min (formule de Cockcroft)
    - Femme enceinte ou allaitante
    - Femme en âge de procréer ou homme n’utilisant pas de méthode contraceptive efficace (HAS)
    - Patient(e) présentant une infection bactérienne, virale, fongique, mycobactérienne évolutive ou toute autre infection évolutive ou tout autre épisode important d'infection ayant nécessité une hospitalisation ou une antibiothérapie par voie IV au cours des quatre semaines précédant l'inclusion dans l'étude
    - Patient(e) présentant une immunodéficience connue primaire ou secondaire active
    - Patient(e) ayant bénéficié de l'administration d’un vaccin vivant dans les 4 semaines précédant l’inclusion
    - Patient(e) ayant bénéficié de plus de 250 séances de photothérapie
    - Patient(e) présentant une néoplasie évolutive quelle que soit sa nature (hormis carcinome in situ du col utérin)
    - Patient(e) présentant un antécédent récent de cancer pouvant contre indiquer l’utilisation d’un immunosuppresseur (a priori, et sauf exception, durant les 5 dernières années avant l’inclusion dans l’étude)
    - Patient(e) sous tutelle ou curatelle
    - Patient(e) non affilié(e) à un régime de protection sociale
    E.5 End points
    E.5.1Primary end point(s)
    The main assessment criterion is the VASI score reduction in the experimental group receiving MTX + UVB TL01 assessed 8 months after the start of treatment. With the integration in the study of a group of randomized calibration receiving Placebo + UVB TL01, the assessment of the main assessment criterion will be without knowledge of the treatment received. In the VASI score body is divided in 5 regions (hands, limbs, trunk, limbs and feet). The surface reached on each region is evaluated by the unit "Palm of hand". The importance of residual pigmentation within a target lesion is expressed as a percentage: 0%, 10%, 25%, 50%, 75%, 100%. The VASI score is then evaluated by a mathematical formula including the surface reached for each region with the percentage of residual pigmentation.
    Le critère de jugement principal est la réduction du score VASI dans le groupe expérimental recevant MTX + UVB TL01 évalué 8 mois après le début du traitement. Grâce à l’intégration dans l’étude d’un groupe de calibration randomisé recevant Placebo + UVB TL01, l’évaluation du critère de jugement principal se fera en insu du traitement reçu.
    Dans le score VASI le corps est divisé en 5 régions (mains, membres supérieurs, tronc, membres inférieurs et pieds). La surface atteinte sur chaque région est évaluée par l’unité paume de main. L’importance de la pigmentation résiduelle au sein d’une lésion cible est exprimée en pourcentage : 0%, 10%, 25%, 50%, 75%, 100%. Le score VASI est ensuite évalué par une formule mathématique incluant la surface atteinte pour chaque région avec le pourcentage de pigmentation résiduelle.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 8
    Mois 8
    E.5.2Secondary end point(s)
    The secondary evaluation criteria are also evaluated without knowledge of the treatment received. The reduction of the VASI score will also be evaluated to M4. The following criteria will be evaluated to M4 and M8:-measures clinical and biological safety of MTX and phototherapy. -changes in the score VETF: VETF score: three areas are assessed: 1 / the skin surface: the body is divided into 5 regions (face and neck, trunk, upper limbs, lower limbs, feet and hands) and the surface is estimated by the rule 9, 2 / severity depigmentation is evaluated by criteria ranging from 0 to 4 (0: normal pigmentation, 1: incomplete pigmentation, 2: complete depigmentation, 3: presence of white hairs < 30%, 4: complete depigmentation of the hair), 3 / the progression assessed by 3 criteria (0): similar limitations, + 1 progression, regression-1). -variation of the students score: this score is built from images representing different parts of the body (face and neck, tron...
    Les critères d’évaluation secondaires sont également évalués en insu du traitement reçu.
    La réduction du score VASI sera aussi évaluée à M4.
    Les critères suivants seront évalués à M4 et M8 :
    -mesures cliniques et biologiques de la sécurité du MTX et de la photothérapie.
    -variation du score VETF : dans le score VETF : trois domaines sont évalués :
    1/ la surface cutanée : le corps est divisé en 5 régions (face et cou, tronc, membres supérieurs, membres inférieurs, pieds et mains) et la surface est estimée par la règle des 9,
    2/ la sévérité de la dépigmentation est évaluée par des critères allant de 0 à 4 (0 : pigmentation normale, 1 : pigmentation incomplète, 2 : dépigmentation complète, 3 : présence de poils blancs <30%, 4 : dépigmentation complète des poils),
    3/ la progression évaluée par 3 critères (0 : limites similaires, +1 progression, -1 régression).
    -variation du score VES : ce score est construit à partir d’images représentant différentes parties du corps (visage et cou, tronc, membres supérieurs et inférieurs, pieds et mains) et différentes évolutions classiques du vitiligo. L’utilisateur clique sur chaque image représentant les zones atteintes par le patient. Ce score est calculé automatiquement à partir d’un site internet dédié.
    -variation du score DLQI (Dermatology Quality of Life Index), des scores VIPs et SkinDex29.
    -variation des paramètres inflammatoires sanguins et cutanés : ELISA sur sérum à l’inclusion, M2, M4 et M8. Immunohistochimie/immunofluorescence et étude transcriptomique sur biopsies cutanées à l’inclusion et à M4.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 8
    Mois 8
    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 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 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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state45
    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 Decision2022-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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