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    Summary
    EudraCT Number:2016-002076-28
    Sponsor's Protocol Code Number:P151202
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-19
    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 number2016-002076-28
    A.3Full title of the trial
    Phase II Study of Pembrolizumab (MK-3475) as First Line Single Drug Therapy in Patients with unresectable Squamous Cell Carcinoma of the Skin
    Etude de phase II de l'administration de Pembrolizumab (MK-3475) en monothérapie et en première ligne chez des patients présentant un carcinome épidermoïde cutané non opérable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of efficacity and safety of pembrolizumab
    A.3.2Name or abbreviated title of the trial where available
    CARSKIN
    A.4.1Sponsor's protocol code numberP151202
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 supportMERCK Sharp and Dohme
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCD Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailfrance.guyot@aphp.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 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 namePembrolizumab
    D.3.2Product code MK-3475 (Anti-PD-1)
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpembrolizumab
    D.3.9.1CAS number 1374856-91-4
    D.3.9.3Other descriptive nameAnti-PD1 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Yes
    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.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
    Patients with unresectable Squamous Cell Carcinoma of the Skin will be included.
    Les patients présentant un carcinome épidermoïde de la peau non opérable seront inclus
    E.1.1.1Medical condition in easily understood language
    unresectable squamous cell carcinoma of the skin
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10041834
    E.1.2Term Squamous cell carcinoma of skin
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To prospectively assess the response rate (RR) at 15 weeks by Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in patients with locally advanced or metastatic squamous cell carcinoma of the skin treated by pembrolizumab with central radiology review
    Evaluer prospectivement le Taux de réponse (RR) à 15 semaines par les critères d'évaluation de la réponse dans les tumeurs solides (RECIST v.1.1) chez les patients présentant un carcinome épidermoïde de la peau localement avancé ou métastatique traitée par pembrolizumab avec une relecture radiologique centralisée
    E.2.2Secondary objectives of the trial
    To assess safety profile of pembrolizumab
    To assess whether patients with PD-L1-positive tumors have a better Response Rate (RR) than the whole sample at 15 weeks using RECIST v.1.1
    To assess in the whole sample and in PD-L1 positive patients:
    - Disease Control Rate at 15 weeks using RECIST 1.1 and modified RECIST 1.1
    - RR at 15 weeks using modified RECIST 1.1
    - RR at 24 weeks using RECIST 1.1 and modified RECIST 1.1
    - Best RR using RECIST 1.1 and modified RECIST 1.1
    - Overall Survival
    - Progression Free Survival, Duration of response, Duration of control, Time to disease progression by RECIST 1.1 and modified RECIST 1.1
    Caractériser le profil de sécurité du pembrolizumab
    Déterminer si les patients avec des tumeurs PD-L1 positives ont un meilleur taux de réponse que l'échantillon global à 15 semaines selon les critères RECIST v.1.1
    Déterminer dans l'échantillon global et chez les patients exprimant PD-L1 :
    - Taux de contrôle de la maladie à 15 semaines selon les critères RECIST 1.1 et les critères RECIST 1.1 modifiés
    - Taux de réponse à 15 semaines selon les critères RECIST 1.1 modifiés
    - Taux de réponse à 24 semaines dans l'échantillon global selon les critères RECIST 1.1 et RECIST 1.1 modifiés
    - Meilleur taux de réponse selon les critères RECIST 1.1 et RECIST 1.1 modifiés
    - Survie globale
    - Survie sans progression, Durée de réponse, Durée de contrôle, Délai avant progression de la maladie selon les critères RECIST 1.1 et RECIST 1.1 modifiés
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    " Be willing and able to provide written informed consent/assent for the trial.
    " Be 18 years of age on day of signing informed consent.
    " Be either affiliated to, or a beneficiary of, a social security category
    " Have metastatic disease, or locally advanced disease not amenable to surgery with documented progression
    " Be willing and able to undergo pre-treatment baseline biopsy of the tumor
    " PD-L1+ or PD-L1- tumors
    " Have measurable disease based on RECIST 1.1
    " Have a performance status of 0 or 1 on the ECOG Performance Scale.
    " Demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation.
    " Have recovered from major surgery or radiation therapy
    " Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
    " Female subjects of childbearing potential should be willing to use 1 method of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 7.5.1). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
    Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
    - Consentement éclairé signé pour l'étude.
    - Agé de 18 ans le jour de la signature du consentement.
    - Patient affilié à ou bénéficiaire de la Sécurité Sociale.
    - Carcinome épidermoïde cutané localement évolué inopérable ou métastatique dont la progression est documentée.
    - Consentement à une biopsie tumorale pendant la phase de pré-inclusion permettant l'analyse de l'expression de PD-L1.
    - Statut PD-L1+ ou PD-L1 - de la tumeur.
    - Maladie mesurable selon les critères RECIST 1.1.
    - ECOG (Eastern Cooperative Oncology Group) : 0 ou 1
    - Les sujets doivent avoir des fonctions hématopoïétique, rénale, hépatique et de coagulation correctes, dans les 10 jours qui précèdent l'initiation du traitement :
    - A récupéré suite à une opération importante ou une radiothérapie.
    - Les femmes en âge de procréer doivent présenter un test de grossesse urinaire ou sanguin négatif dans les 72 heures précédant l'administration de la 1ère dose du traitement à l'étude. Si le test urinaire est positif ou ne peut être confirmé comme négatif, un test de grossesse sanguin doit être réalisé.
    - Les femmes en âge de procréer doivent utiliser une méthode efficace de contraception pendant le traitement par pembrolizumab et pendant au moins 4 mois après la dernière administration du pembrolizumab (Référence Paragraphe 7.5.1). Les femmes en âge de procréer sont des femmes non stérilisées chirurgicalement ou qui n'ont pas eu une absence de règles pendant > 1 an.
    - Les hommes doivent utiliser une méthode de contraception adéquate du 1er jour de traitement à l'étude et jusqu'à 120 j après la dernière dose de traitement.
    E.4Principal exclusion criteria
    " Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks or 5 half-lives (minimum 14 days), whichever is shorter, prior to the first dose of treatment.
    " Has received prior therapy with either chemotherapy or targeted therapy for the present tumor
    " Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
    " Has received radiation therapy within 4 weeks prior to study Day 1
    " Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    " Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
    " Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
    " Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
    " Has known history of, or any evidence of active, non-infectious pneumonitis.
    " Has an active infection requiring systemic therapy
    " Has received a live vaccine within 30 days of planned start of study therapy.
    " Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Fluenz tetra®) are live attenuated vaccines, and are not allowed.
    " Hypersensitivity to pembrolizumab or any of its excipients.
    " Has a known additional malignancy. Exceptions include i) basal cell carcinoma of the skin or other squamous cell carcinoma of the skin or in situ cervical cancer, ii) history of another non blood malignancy that has undergone potentially curative therapy without recurrence for more than 2 years.
    " Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with brain metastases may participate provided they are stable (without evidence of progression by imaging for at least eight weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
    " Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
    " Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    " Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
    - Participation simultanée à une autre étude avec un traitement expérimental ou avoir pris un traitement expérimental ou utilisé un dispositif médical dans les 4 semaines ou 5 demi-vies (minimum 14 jours), selon le délai le plus court, avant la 1ère dose de traitement à l'étude.
    - Traitement antérieur de la tumeur actuelle par chimiothérapie ou thérapie ciblée.
    - Traitement antérieur par anti-PD-1, anti-PD-L1 ou anti-PD-L2.
    - Radiothérapie dans les 4 semaines précédant la 1ère administration du traitement à l'étude
    - Maladie auto-immune qui a nécessité un traitement systémique dans les 2 dernières années (c'est-à-dire avec l'utilisation de produits modificateurs de la maladie, corticostéroïdes ou médicaments immunosuppresseurs). La thérapie de substitution (par exemple: thyroxine, insuline ou corticothérapie de substitution physiologique pour insuffisance surrénalienne ou hypophysaire, etc) n'est pas considérée comme une forme de traitement systémique.
    - A une immunodépression ou reçoit un traitement systémique par stéroïdes ou toute autre forme de traitement immunosuppresseur dans les 7 j précédant la 1ère dose du traitement à l'étude.
    - antécédent de séropositivité pour le VIH (Ac VIH 1/2)
    - Hépatite B active (ex. positivité de l'Ag HBs) ou hépatite C active (ex. détection d'ARN-VHC).
    - Antécédent ou signe actif de pneumopathie non-infectieuse.
    - Infection active nécessitant un traitement systémique
    - Vaccination par un vaccin vivant dans les 30 j précédant le début du traitement à l'étude.
    Remarque: les vaccins par injection contre la grippe sont généralement des vaccins inactivés et sont autorisés; cependant les vaccins nasaux contre la grippe sont vivants atténués (exemple: Fluenz tetra®) et ne sont pas autorisés.
    - Hypersensibilité au pembrolizumab ou l'un de ses excipients.
    - Antécédent de tumeur maligne. Les exceptions sont : i) les carcinomes basocellulaires, carcinomes épidermoïdes cutanés ou carcinomes du col in situ ii) histoire de cancer non hématologique qui a été traité à visée curative et qui n'a pas récidivé depuis au moins 2 ans.
    - Métastases du système nerveux central (SNC) et/ou méningite carcinomateuse. Les sujets avec des métastases cérébrales peuvent participer si elles sont stables (sans progression évidente par imagerie pendant au moins 8 semaines avant la 1ère dose du traitement de l'étude et tous les symptômes neurologiques sont revenus à leur valeur initiale), pas de nouvelle métastase cérébrale ou d'augmentation de taille des métastases cérébrales, et pas d'utilisation de stéroïdes pendant au moins 7 j avant l'initiation du traitement de l'étude. Cette exception n'inclut pas les méningites carcinomateuses qui sont exclues quelle que soit l'évolution.
    - Antécédent ou preuve actuelle de toute condition, traitement, anomalie dans un examen de laboratoire qui pourrait fausser les résultats de l'essai, interférer avec la participation du sujet pendant la durée totale de l'essai ou ne serait pas du meilleur intérêt du patient de participer, selon l'investigateur.
    - Troubles psychiatriques connus ou toxicomanie qui pourraient compromettre la capacité du patient à suivre le protocole.
    - Femme enceinte ou allaitante ou patient homme/femme souhaitant concevoir pendant toute la durée de l'étude à partir des examens de screening et jusqu'à 120 j après l'arrêt du traitement à l'étude.


    E.5 End points
    E.5.1Primary end point(s)
    Primary assessment criterion

    The primary assessment criterion will be the response rate at 15 weeks defined as the proportion of patients presenting either a complete or a partial response at 15 weeks with central radiology review by CT / MRI according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.1).

    Secondary assessment criterion

    Adverse events (AEs) will be graded and recorded throughout the study and during the follow-up period according to CTCAE, V4.0

    Disease Control Rate defined as the proportion of patients presenting either complete response [CR], partial response [PR], or stable disease) after 15 weeks of treatment with pembrolizumab with central radiology review by CT or MRI according to RECIST v.1.1 and modified RECIST v.1.1.

    Response rate at 15 weeks defined as the proportion of patients in the whole sample and in the PD-L1 positive group presenting either a complete or a partial response at 15 weeks with central radiology review by CT or MRI using modified RECIST 1.1.

    Best response rate using RECIST and modified RECIST 1.1. is the best response rate observed during the whole study

    Overall survival defined as the number of days from the first infusion of pembrolizumab until week 96 or death from any cause, and is measured in the intent-to-treat population.

    Progression Free Survival defined as the number of days from the first dose of pembrolizumab to the earliest day of either progression by RECIST 1.1 and modified RECIST 1.1 or starting another anticancer treatment, or death from any cause.

    Response duration is measured as the number of days from the time of initial response until documented tumor progression by RECIST 1.1 and modified RECIST 1.1.

    Duration of control among patients whose disease was controlled at week 15 is calculated as the number of days from the start of treatment to the earliest day of progressive disease without other anticancer treatment using RECIST 1.1 and modified RECIST 1.1.

    Time to disease progression defined as the number of days from the first dose of pembrolizumab until objective tumor progression or death if it occurs before progression by RECIST 1.1 and modified RECIST 1.1.

    Critère d'évaluation principal

    Le critère d'évaluation principal sera le taux de réponse à 15 semaines défini comme la proportion de patients présentant soit une réponse complète soit une réponse partielle à 15 semaines évalué par CT / IRM selon les critères d'évaluation de réponse dans les tumeurs solides (RECIST v1.1) et relecture centralisée.

    Critères d'évaluation secondaires

    Les événements indésirables (EI) seront évalués et enregistrés tout au long de l'étude et pendant la période de suivi selon le CTCAE v4.0

    Le Taux de contrôle de la maladie est défini comme la proportion de patients présentant soit une réponse complète [CR], réponse partielle [PR], ou une maladie stable après 15 semaines de traitement avec le pembrolizumab avec une relecture centralisée par CT ou IRM selon RECIST v.1.1 et RECIST v.1.1 modifiés.

    Le Taux de réponse à 15 semaines est défini comme la proportion de patients dans l'ensemble de l'échantillon et dans le groupe positif PD-L1 présentant soit une réponse complète, soit une réponse partielle à 15 semaines avec relecture centralisée par CT ou IRM en utilisant RECIST 1.1 modifié.

    Le Meilleur taux de réponse en utilisant RECIST 1.1 et RECIST 1.1modifiés, est le meilleur taux de réponse observé pendant toute l'étude

    La survie globale est définie comme le nombre de jours à partir de la première perfusion de pembrolizumab jusqu'à la semaine 96 ou du décès de toute cause, et est mesurée dans la population en intention de traiter.

    La Survie sans progression est définie comme le nombre de jours à partir de la première dose de pembrolizumab jusqu'au premier jour de la progression de la maladie en RECIST 1.1 et RECIST 1.1 modifié ou à partir d'un autre traitement anticancéreux, ou la mort de toute cause.

    la durée de réponse est mesurée par le nombre de jours à partir de la réponse initiale jusqu'à la progression de la tumeur documentée par RECIST 1.1 et RECIST 1.1 modifiés .

    La Durée du contrôle chez les patients dont la maladie a été contrôlée à la semaine 15 est calculée comme le nombre de jours depuis le début du traitement jusqu'au premier jour de la progression de la maladie sans autre traitement anticancéreux en utilisant RECIST 1.1 et RECIST 1.1 modifié.

    Le temps de progression de la maladie est défini comme le nombre de jours à partir de la première dose de pembrolizumab jusqu'à progression tumorale objective ou le décès si elle se produit avant la progression par RECIST 1.1 et RECIST 1.1 modifié .
    E.5.1.1Timepoint(s) of evaluation of this end point
    15 weeks
    15 semaines
    E.5.2Secondary end point(s)
    Toxicity profile (CTCAE v.4.0)
    Response Rate at 15 weeks in the PD-L1 positive patients (RECIST v.1.1)
    In the whole sample and in PD-L1 positive patients
    - Disease Control Rate at 15 weeks using RECIST and modified RECIST v.1.1
    - Response Rate at 15 weeks using modified RECIST 1.1
    - Response Rate at 24 weeks using RECIST and modified RECIST v.1.1
    - Best Response Rate using RECIST and modified RECIST v.1.1
    - Overall Survival (OS) and 1 and 2 years
    - Progression Free Survival by RECIST 1.1 and modified RECIST 1.1
    - Duration of response (DOR) by RECIST 1.1 and modified RECIST 1.1
    - Duration of control by RECIST 1.1 and modified RECIST 1.1
    - Time to disease progression by RECIST 1.1 and modified RECIST 1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    24 mois
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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 Yes
    E.7.1.3.1Other trial type description
    phase II
    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 concerned31
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state39
    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 Decision2016-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-15
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