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    Summary
    EudraCT Number:2017-000519-18
    Sponsor's Protocol Code Number:P160906J
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-09-25
    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 number2017-000519-18
    A.3Full title of the trial
    PIMOC : Personalized targeted therapies in inflammatory complex multi organ disease
    Personnalisation des traitements de Pathologies Inflammatoires Multi Organes Complexes : PIMOC
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PIMOC : Personalized targeted therapies in inflammatory complex multi organ disease
    Personnalisation des traitements de Pathologies Inflammatoires Multi Organes Complexes : PIMOC
    A.3.2Name or abbreviated title of the trial where available
    PIMOC
    PIMOC
    A.4.1Sponsor's protocol code numberP160906J
    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 supportDGOS
    B.4.2CountryFrance
    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 pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number330144841738
    B.5.5Fax number330144841701
    B.5.6E-mailjosephine.braun@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 Yes
    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 nameSECUKINUMAB
    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 INNSECUKINUMAB
    D.3.9.1CAS number 1229022-83-6
    D.3.9.3Other descriptive nameSECUKINUMAB
    D.3.9.4EV Substance CodeSUB33242
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150 mg/1 ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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 nameADALIMUMAB
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40mg/0.4 ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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 nameANAKINRA
    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 INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.4EV Substance CodeSUB05500MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100mg/0.67ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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 nameRITUXIMAB
    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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    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.2.1.2Country 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 nameTOCILIZUMAB
    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 INNTOCILIZUMAB
    D.3.9.1CAS number 375823-41-9
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number480
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 6
    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.2.1.2Country 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 nameUSTEKINUMAB
    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 INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.3Other descriptive nameUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45mg/0.5 ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 presenting inflammatory non classified disease targeting at least 2 organs involvement: skin, lymph nodes, hemopoietic system, joints, digestive tract. The disease has been resistant to at least two prior lines of treatment.
    Patient(e) présentant une maladie inflammatoire mal classée, impliquant au moins deux organes dont au moins la peau, et un des suivants : ganglions lymphatiques, système hématopoïétique, articulations, appareil digestif. La maladie a été résistante à au moins deux lignes de traitement.
    E.1.1.1Medical condition in easily understood language
    Patients presenting inflammatory non classified disease, resistant to prior treatment
    patients présentant une maladie inflammatoire non classée, sévère et résistante
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10062249
    E.1.2Term Skin inflammation
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to evaluate the efficacy of targeted treatments in patients displaying a non-classified, severe and resistant inflammatory disease. Targeted treatments for each patient will have been selected through an algorithm based on molecular analysis of specific altered inflammatory signaling pathway.
    L'objectif principal de cette étude est d'évaluer l'efficacité de traitements ciblés chez des patients présentant une maladie inflammatoire non classée, sévère et résistante. Le traitement ciblé pour chaque patient aura été sélectionné grâce à un algorithme basé sur l'analyse moléculaire de la voie de signalisation inflammatoire spécifique.
    E.2.2Secondary objectives of the trial
    (a) to analyze the safety at several time points of targeted treatment selected through molecular based algorithm, (b) to analyze the other clinical global and cutaneous efficacy parameters
    (c) to study whether the treatment selected has been able to inhibit the culprit pathway using mRNA analysis before and after treatment as well as serum markers before and after treatment
    (d) to assess whether full RNA sequencing can depict in lesional skin, overexpressed pathway(s) that the targeted RNA set has not detected
    (a) analyser la tolérance à plusieurs temps du traitement sélectionné
    (b) analyser les autres paramètres d’efficacité cliniques globaux et d'efficacité cutanée.
    (c) vérifier que le traitement sélectionné a permis d’inhiber la voie moléculaire considérée comme responsable.
    (d) évaluer si le séquençage complet de l'ARN (« ARN seq ») peut dépister dans la peau lésée et saine, une ou des voie (s) surexprimée (s) que l’analyse antérieure ciblées n'aurait pas détecté
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients (men or women) aged 18 years old and over
    -Patients presenting inflammatory non classified disease targeting at least 2 organs involvement: skin, lymph nodes, hemopoietic system, joints, digestive tract. Skin involvement is mandatory in order to be able to compare involved and non involved tissue
    -Signed informed consent

    The disease should be considered as non-classified despite classical and adapted investigations and evaluation through expert committee meeting.
    The disease alters significantly quality of life using SF36 assessment : score less than 30.
    The disease has been resistant to at least two prior lines of treatment.
    -Patient (homme ou femme) âgé de 18 ans ou plus
    -Patient(e) présentant une maladie inflammatoire mal classée, impliquant au moins deux organes dont au moins la peau, et un des suivants : ganglions lymphatiques, système hématopoïétique, articulations, appareil digestif
    -Patient(e) ayant donné son consentement éclairé et écrit pour participer à l'étude

    La maladie est considérée comme une pathologie inflammatoire multi organes complexe après des investigations habituelles et une évaluation par un Comité d’experts.
    La maladie altère de façon significative la qualité de vie en utilisant le questionnaire SF-36 (score < 30).
    La maladie a été résistante à au moins deux lignes de traitement.
    E.4Principal exclusion criteria
    -Patients presenting disease which is not featured by lesional and healthy skin areas, easy to biopsy
    -Patients refusing biopsies
    -Pregnancy
    -Women of child-bearing potential unable to receive highly efficient contraception such as combined oral contraceptives, intra-uterine disposals, hormonal implants or the use of male condoms recommended in case of unstable or irregular partner or as a replacement method for transient unacessebility to hormonal method
    -Breastfeeding
    -Patients presenting disease needing urgent therapeutic measures
    -Patients without health insurance or social security
    -Patients under legal protection
    -Participation in another interventional trial
    -Patients unable to respect the wash out delay of previously taken medications before inclusion time :
    *Hydroxychloroquine (wash out period = 30 days)
    *Chloroquine (wash out period = 7 days)
    *Colchicine (wash out period = 7 days)
    *Methotrexate (wash out period = 7 days)
    *Ciclosporine (wash out period = 14 days)
    *Azathioprine (wash out period = 14 days)
    *Mycophenolate mofetil (wash out period = 14 days)
    *Disulone (wash out period = 7 days)
    *Corticosteroids (=prednisone, prednisolone, dexamethasone, methylprednisolone) (wash out period = 7 days)
    -Patients with contra-indications to treatments: Severe or active infections including tuberculosis

    Importantly, in this study, the treatment will be selected by a committee depending on three criteria (cf Design of the trial: Interpretation of the data) including contra indications of the patients to the drugs. Therefore, contra indicated medications cannot be selected by the committee in view of protocol participation.
    -Patient(e) dont la maladie ne comporte pas une zone de peau lésée cutanée et une zone de peau saine faciles à biopsier
    -Patient(e) refusant les biopsies
    -Femme enceinte ou allaitante
    -Les femmes en âge de procréer n’utilisant pas un moyen de contraception efficace, tels que les contraceptifs oraux, les dispositifs intra-utérins et les implants hormonaux ou l’usage du préservatif masculin recommandé en cas d’absence de partenaire stable ou en méthode de remplacement à garder à disposition en cas d’inaccessibilité ponctuelle ou de défaut d’observance d’une méthode hormonale.
    -Patient(e) présentant une maladie nécessitant des soins médicaux d’urgence
    -Patient(e) ne disposant pas d’un régime de sécurité sociale
    -Patient(e) sous protection juridique
    -Patient(e) participant à un autre essai interventionnel
    -Patient(e) ne pouvant pas, au moment de son inclusion dans l’étude, respecter les délais de wash-out par rapport aux traitements pris précédemment:
    *Hydroxychloroquine (période de wash-out = 30 jours)
    *Chloroquine (période de wash-out = 7 jours)
    *Colchicine (période de wash-out = 7 jours)
    *Méthotrexate (période de wash-out = 7 jours)
    *Ciclosporine (période de wash-out = 14 jours)
    *Azathioprine (période de wash-out = 14 jours)
    * Mycophenolate mofetil (période de wash-out = 14 jours)
    *Disulone (période de wash-out = 7 jours)
    *Corticosteroïdes (=prednisone, prednisolone, dexaméthasone, méthylprednisolone) (période de wash-out = 7 jours)
    -Patient(e) présentant des contre-indications aux traitements:
    Infections sévères ou actives dont la tuberculose

    Important : dans cette étude, le traitement sera sélectionné par un comité notamment en prenant en compte les contre-indications des patients aux traitements évalués. Par conséquent, un patient ne pourra recevoir un traitement pour lequel il présente une contre-indication.
    E.5 End points
    E.5.1Primary end point(s)
    Response will be assessed at month 6 with a composite endpoint defined as improvement of at least 2 of the 3 following parameters:
    - 50% improvement of the systemic activity assessed by the clinician following a visual analog scale (0-10),
    - and/or 50% improvement of cutaneous activity assessed by the involved skin surface area,
    - and/or 50% decrease or nomalisation of biological markers of inflammation (either CRP, ESR or fibrin).
    An independent adjudication committee blinded to the treatment received will review primary endpoint for all patients based on clinical files and standardized photographs, to validate the response.
    La réponse sera évaluée au 6ième mois avec un critère composite défini comme l'amélioration d'au moins 2 des 3 paramètres suivants :
    - Amélioration de 50% de l'activité systémique évaluée par le clinicien selon une échelle visuelle analogique (0-10),
    - et / ou 50% d'amélioration de la surface cutanée concernée,
    - et / ou une diminution de 50% ou une normalisation des marqueurs biologiques de l'inflammation (CRP, VS ou fibrinogène).
    Un comité indépendant, en insu du traitement reçu, examinera le critère d'évaluation principal pour tous les patients afin de valider la réponse, à l’aide des dossiers cliniques et des clichés standardisés
    E.5.1.1Timepoint(s) of evaluation of this end point
    at month 6
    à 6 mois
    E.5.2Secondary end point(s)
    a) Adverse events (mainly infections, liver, kidney and blood cell count toxicities) of targeted treatment selected through molecular analysis during patient follow up using the CTCAE classification
    b) The following parameters will be assessed at various time-points and compared with baseline values:
    Physician Assessment of systemic activity (PGA) at M1, M3, M6 to M12
    Physician Assessment of cutaneous activity (PGA) at M1, M3, M6 to M12
    Biological markers of inflammation (CRP, ESR and fibrin) at M1, M3, M6 to M12
    BILAG, CLASI, SF36 and SRI score at M3, M6 to M12
    c) Reduction of the selected mRNA in skin and peripheral blood at M1, M3, M6 and M12
    d) Reduction of the selected cytokine in serum at M1, M3, M6 and M12
    e) RNA sequencing analysis in lesional versus non lesional skin at M0 with bioinformatics analysis
    f) Ability using molecular tools to better classify “atypical disease” into a taxonomy of standard disease groups
    g) Determine whether PBL and serum changes are informative in the design and/or the response of therapies for inflammatory diseases

    E.5.2.1Timepoint(s) of evaluation of this end point
    M1, M3, M6 to M12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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 trial6
    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 concerned9
    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
    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 months
    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: 19
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 state32
    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)
    Normal treatment of this condition
    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 Decision2019-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-19
    P. End of Trial
    P.End of Trial StatusOngoing
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