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    Summary
    EudraCT Number:2022-002003-37
    Sponsor's Protocol Code Number:CHUBX2022/03
    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:2023-01-27
    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 number2022-002003-37
    A.3Full title of the trial
    Efficacy and tolerance of the association of ANIFROLUMAB (300mg) IV every four weeks and phototherapy versus phototherapy in adults with progressive vitiligo: a randomized double blind prospective, non comparative Proof of Concept phase II study
    Efficacité et tolérance de l’association de l’anifrolumab (300 mg intraveineux) et de la photothérapie par rapport à la photothérapie seule chez les adultes atteints de vitiligo progressif : une étude randomisée, en double aveugle, prospective, non comparative de phase II.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of the combination of anifrolumab (300 mg IV) and phototherapy versus phototherapy in adults with progressive vitiligo
    Efficacité et tolérance de l’association de l’anifrolumab (300 mg IV) et de la photothérapie par rapport à la photothérapie chez les adultes atteints de vitiligo progressif
    A.3.2Name or abbreviated title of the trial where available
    VITANI
    VITANI
    A.4.1Sponsor's protocol code numberCHUBX2022/03
    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 SponsorCentre Hospitalier Universitaire 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 supportAstra Zeneca France
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Universitaire 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 number+33557821158
    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 Saphnelo
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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.3.1Product nameAnifrolumab
    D.3.2Product code MEDI-546
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrauterine use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnifrolumab
    D.3.9.1CAS number 1326232-46-5
    D.3.9.4EV Substance CodeSUB128931
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    non-segmental (symmetrical) vitiligo with a body surface area involved >5% excluding hands and feet
    vitiligo non segmentaire (symétrique) avec une surface corporelle concernée >5% à l'exclusion des mains et des pieds
    E.1.1.1Medical condition in easily understood language
    non-segmental (symmetrical) vitiligo with a body surface area involved >5% excluding hands and feet
    vitiligo non segmentaire (symétrique) avec une surface corporelle concernée >5% à l'exclusion des mains et des pieds
    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
    evaluate the efficacy of the combination of ANIFROLUMAB intravenous (IV) every four weeks + UVB TL01 (twice a week) by the evaluation of the percentage of skin repigmentation after 36 weeks of treatment using the VASI score in the experimental group receiving ANIFROLUMAB + UVB TL01.
    Evaluer l’effet de la combinaison ANIFROLUMAB (par voie intraveineuse) 300 mg toutes les 4 semaines + UVB TL01 (deux fois par semaine) en évaluant le pourcentage de repigmentation de la peau après 36 semaines de traitement à l'aide du score VASI chez les patients atteints de vitiligo recevant ANIFROLUMAB + UVBTL01.
    E.2.2Secondary objectives of the trial
    Evaluate the efficacy of the combination of ANIFROLUMAB IV every four weeks + UVB TL01 (twice a week) by the evaluation of the percentage of skin repigmentation after 12 weeks of treatment using the VASI score in the experimental group receiving ANIFROLUMAB + UVB TL01.
    Following objectives will be evaluated 12, 20 and 36 weeks after inclusion.
    • To evaluate the safety and tolerability of the combination of ANIFROLUMAB IV

    Following objectives will be evaluated 48 weeks after inclusion: 12 weeks after stopping the experimental procedure
    Evaluer l'efficacité de l'association ANIFROLUMAB IV toutes les quatre semaines + UVB TL01 (deux fois par semaine) par l'évaluation du pourcentage de repigmentation cutanée après 12 semaines de traitement à l'aide du score VASI dans le groupe expérimental recevant ANIFROLUMAB + UVB TL01.
    Les objectifs suivants seront évalués 12, 20 et 36 semaines après l'inclusion.
    - Évaluer l'innocuité et la tolérabilité de l'association d'ANIFROLUMAB IV.

    Les objectifs suivants seront évalués 48 semaines après l'inclusion : 12 semaines après l'arrêt de la procédure expérimentale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject: male or female aged ≥ 18 years and ≤ 65 years
    - Subject with body weight  40kg
    - Diagnosis of non-segmental (symmetrical) vitiligo with a body surface area involved >5% excluding hands and feet
    - Active non-segmental vitiligo is 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.
    - Able to read, understand, and give documented (electronic or paper signature) informed consent
    - Registered in the French Social Security
    - Agree to discontinue the use of the following excluded medications/treatments for at least 4 weeks prior to randomization (Visit 2) and throughout the study: systemic steroids, phototherapy, methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine.
    - Agree to discontinue the use of the following excluded medications for at least 2 weeks prior to randomization (Visit 2) and throughout the study:
    • TCS or topical immune modulators (e.g., tacrolimus or pimecrolimus)
    • Topical phosphodiesterase type 4 (PDE-4) inhibitor (crisaborole)
    • Topical JAK inhibitor (e.g., tofacitinib or ruxolitinib) and/or any other investigational topical treatments.

    - Patient characteristics
    - Are male or nonpregnant, nonbreastfeeding female patients, except:
    a. Male patients must agree to use 2 forms of birth control (1 must be highly effective, see below) while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study and for at least 4 weeks following the last dose of investigational product.

    b. Female patients of childbearing potential must agree to use 2 forms of birth control, when engaging in sexual intercourse with a male partner while enrolled in the study and for at least 12 weeks following the last dose of investigational product.
    The following birth control methods are considered acceptable (the patient should choose 2 to be used with their male partner, and 1 must be highly effective):
    • Highly effective birth control methods: oral, injectable, or implanted hormonal contraceptives (combined estrogen/progesterone or progesterone only, associated with inhibition of ovulation); intrauterine device (containing copper) or intrauterine system (e.g., progestin-releasing coil); or vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate).
    • Effective birth control methods: condom with a spermicidal foam, gel, film, cream, or suppository; occlusive cap (diaphragm or cervical/vault caps) with a spermicidal foam, gel, film, cream, or suppository; or oral hormonal contraceptives.

    c. Females of nonchildbearing potential are not required to use birth control and they are defined as:
    • Women ≥60 years of age or women who are congenitally sterile, or
    • Women ≥40 and <60 years of age who have had a cessation of menses for ≥12 months and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (≥40 mIU/mL or ≥40 IU/L), or women who are surgically sterile (i.e., have had a hysterectomy or bilateral oophorectomy or tubal ligation).
    - Patients fully vaccinated against COVID-19. A patient is considered fully vaccinated ≥2 weeks after receipt of the second dose in a 2-dose series (Pfizer-BioNTech and Moderna) or ≥ 2 weeks after receipt of the single dose of the Janssen vaccine.
    - Signed informed consent form (ICF)
    - Homme ou femme âgé de ≥ 18 ans et ≤ 65 ans
    -Patients avec un poids  40kg
    - Diagnostic de vitiligo non segmentaire (symétrique) avec une surface corporelle impliquée >5% à l'exclusion des mains et des pieds
    - Le vitiligo actif non segmentaire est défini par :
    • Vitiligo non segmentaire avec nouvelles lésions ou extension d'anciennes lésions au cours des 6 derniers mois ET
    • Présence d'un aspect hypochrome sous l'examen de la lampe de Wood et/ou de lésions en confettisen lumière de Wood.
    - Capacité à lire, comprendre et donner un consentement éclairé documenté (signature électronique ou sur papier)
    - Affilié ou bénéficiaire d’un régime de sécurité sociale
    - Accepter d’arrêter l'utilisation des médicaments/traitements exclus suivants pendant au moins les 4 semaines précédant la randomisation (visite 2) et pendant toute la durée de l'étude: corticothérapie générale, photothérapie, méthotrexate, cyclosporine, mycophénolate mofétil, azathioprine.
    - Accepter d’arrêter l'utilisation des médicaments exclus suivants pendant au moins les 2 semaines précédant la randomisation (visite 2) et pendant toute la durée de l'étude :
    - TCS ou modulateurs immunitaires topiques (par exemple, tacrolimus ou pimecrolimus)
    - Inhibiteur topique de la phosphodiestérase de type 4 (PDE-4) (crisaborole)
    - Inhibiteur topique de la voie JAK (par exemple, tofacitinib ou ruxolitinib) et/ou tout autre traitement topique expérimental.

    Caractéristiques du patient
    - Hommes ou femmes non enceintes et n'allaitant pas:
    a. Les patients masculins doivent accepter d'utiliser 2 formes de contraception (1 doit être hautement efficace, voir ci-dessous) lors de leurs rapports sexuels avec des partenaires féminines en capacité de procréer pendant qu'ils participent à l'étude et pendant au moins 4 semaines après la dernière administration du produit de la recherche.
    b. Les patientes en capacité de procréer doivent accepter d'utiliser deux méthodes de contraception lorsqu'elles ont des rapports sexuels avec un partenaire masculin pendant qu'elles participent à l'étude et pendant au moins quatre semaines après la dernière administration du produit de la recherche.
    Les méthodes de contraception suivantes sont considérées comme acceptables (le patient doit en choisir 2 dont une hautement efficace) :
    - Méthodes de contraception hautement efficaces : contraceptifs hormonaux oraux, injectables ou implantés (combinaison oestrogène/progestérone ou progestérone seule, associée à une inhibition de l'ovulation) ; dispositif ou système intra-utérin (par exemple, stérilet libérant de la progestérone ou au cuivre) ; ou vasectomie chez l’homme (avec documentation appropriée post-vasectomie de l'absence de spermatozoïdes dans l'éjaculat).
    - Méthodes efficaces de contraception : préservatif avec mousse, gel, film, crème spermicide ou suppositoire ; capuchon occlusif (diaphragme ou cape cervicale) avec mousse, gel, film, crème spermicide ou suppositoire ; ou contraceptifs hormonaux par voie orale.

    c. Les femmes qui ne sont pas en capacité de procréer ne sont pas tenues d'utiliser un moyen de contraception et sont définies comme suit
    - les femmes ≥60 âgées ou les femmes qui ont une stérilité congénitale, ou
    - les femmes ≥40 et <60 ans qui ont eu un arrêt des menstruations depuis ≥12 mois et un test à l'hormone folliculo-stimulante (FSH) confirmant l’incapacité de procréer (≥40 mUI/mL ou ≥40 IU/L), ou les femmes qui sont stériles après chirurgie (hystérectomie ou ovariectomie bilatérale ou ligature des trompes).
    - Patients entièrement vaccinés contre le COVID-19. Un patient est considéré comme entièrement vacciné ≥2 semaines après la réception de la deuxième dose d'une série de 2 doses (Pfizer-BioNTech et Moderna) ou ≥2 semaines après la réception de la dose unique du vaccin Janssen.
    - Formulaire de consentement éclairé signé
    E.4Principal exclusion criteria
    General exclusion criteria
    - Segmental or mixed vitiligo
    - Patients that are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus) that would interfere with evaluations of the effect of study medication on vitiligo
    - Patients who are currently experiencing a skin infection that requires treatment, or who are currently being treated with topical or systemic antibiotics.
    - Patients that have any serious concomitant illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring. (e.g., unstable chronic asthma).

    - Patients with history of basal cell or squamous epithelial skin cancer or melanoma

    - Presence of significant uncontrolled neuropsychiatric disorder, are clinically judged by the investigator to be at risk for suicide.

    - Current alcohol, drug, or chemical abuse.
    Other non inclusion criteria
    - Have hypersensitivity to anifrolumab or to any of the excipients.

    - Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures.

    - Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

    - Have participated within the last 30 days in a clinical study involving an investigational product. If the previous investigational product has a long half-life (2 weeks or longer), at least 3 months or 5 half-lives (whichever is longer) should be allowed between the end of the previous treatment and the inclusion.

    - Have previously been randomized in this study or any other study investigating anifrolumab.
    - Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    Critères d'exclusion généraux
    - Vitiligo segmentaire ou mixte
    - Les patients présentant actuellement ou ayant des antécédents d'autres affections cutanées concomitantes (par exemple, psoriasis ou lupus érythémateux) qui interféreraient avec les évaluations de l'effet du médicament à l'étude sur le vitiligo.
    - Les patients qui présentent actuellement une infection cutanée nécessitant un traitement, ou qui sont actuellement traités par des antibiotiques topiques ou systémiques.
    - Les patients qui présentent une maladie concomitante grave susceptible de nécessiter l'utilisation de corticostéroïdes systémiques ou d'interférer avec la participation à l'étude ou de nécessiter une surveillance active fréquente. (par exemple, asthme chronique instable).

    - Patients ayant des antécédents de cancer de la peau basocellulaire ou squameux épithélial ou de mélanome.

    - Présence d'un trouble neuropsychiatrique significatif non contrôlé, sont cliniquement jugés par l'investigateur comme présentant un risque de suicide.

    - Abus actuel d'alcool, de drogues ou de produits chimiques.
    Autres critères de non-inclusion
    - Avoir une hypersensibilité à l'anifrolumab ou à l'un des excipients.

    - Ne peuvent ou ne veulent pas se rendre disponibles pour la durée de l'étude et/ou ne veulent pas suivre les restrictions/procédures de l'étude.

    - Sont actuellement inscrits à un autre essai clinique impliquant un produit expérimental ou à tout autre type de recherche médicale jugée non compatible avec cette étude sur le plan scientifique ou médical.

    - Ont participé au cours des 30 derniers jours à une étude clinique impliquant un produit expérimental. Si le produit expérimental précédent a une longue demi-vie (2 semaines ou plus), il faut prévoir au moins 3 mois ou 5 demi-vies (la plus longue des deux) entre la fin du traitement précédent et l'inclusion.

    - Ont déjà été randomisés dans cette étude ou dans toute autre étude portant sur l'anifrolumab.
    - Sont des membres du personnel du site investigateur directement affiliés à cette étude et/ou leur famille immédiate. La famille immédiate est définie comme un conjoint, un parent, un enfant, un frère ou une sœur, qu'ils soient biologiques ou légalement adoptés.
    E.5 End points
    E.5.1Primary end point(s)
    Mean variation in percentage of the Vitiligo Area Scoring Index (VASI) score between baseline and week 36
    Variation moyenne en pourcentage du score Vitiligo Area Scoring Index (VASI) entre l’inclusion et la semaine 36.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 36
    Semaine 36
    E.5.2Secondary end point(s)
    - The safety and tolerability of ANIFROLUMAB and phototherapy will be assessed based on clinical and biological exams.
    - Evolution of vitiligo disease
    - Evolution of the activity of vitiligo will be assessed by measuring the variation in percentage of the Vitiligo Signs of Activity Score (VSAS) between baseline , week 12, 24, 36 and 48
    - Evolution of quality of life will be assessed
    - Blood inflammatory markers will be measured at inclusion, week 12, 24, 36 weeks using multiplex ELISA on patients’ serum
    - Skin inflammatory markers will be measured at inclusion, 12 and 36 weeks using immunofluorescence on skin biopsies, and transcriptomic analysis on skin biopsies.
    - La sécurité et la tolérance d'ANIFROLUMAB et de la photothérapie seront évaluées sur la base d'examens cliniques et biologiques.
    - L'évolution de la maladie vitiligo
    - L'évolution de l'activité du vitiligo sera évaluée en mesurant la variation en pourcentage du score des signes d'activité du vitiligo (VSAS) entre la ligne de base et les semaines 12, 24, 36 et 48.
    - L'évolution de la qualité de vie sera évaluée
    - Les marqueurs inflammatoires sanguins seront mesurés à l'inclusion, aux semaines 12, 24 et 36 en utilisant le test ELISA multiplex sur le sérum des patients.
    - Les marqueurs inflammatoires cutanés seront mesurés à l'inclusion, à 12 et 36 semaines par immunofluorescence sur des biopsies cutanées, et par analyse transcriptomique sur des biopsies cutanées.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12, 24, 36 and 48
    Semaines 12, 24, 36 et 48
    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 concerned4
    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 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 years
    E.8.9.1In the Member State concerned months30
    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: 48
    F.1.3Elderly (>=65 years) No
    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 state48
    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)
    No change to what is usually done
    Aucune modification à ce que se fait d'habitude
    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 Decision2023-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-22
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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