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    Summary
    EudraCT Number:2020-000309-10
    Sponsor's Protocol Code Number:CHUBX2017/45
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-05-25
    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 number2020-000309-10
    A.3Full title of the trial
    Phase II/III double-blind randomized placebo-controlled trial assessing the preventive effect of Clopidogrel on the systemic sclerosis development risk in subjects with specific dysimmunity and Raynaud phenomenon
    Essai clinique de phase II/III randomisé en double aveugle versus placebo évaluant l’efficacité d’un traitement Préventif par Clopidogrel sur le risque d’évolution vers une Sclérodermie Systémique chez des sujets présentant une association dysimmuniTé/phénomène de Raynaud
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preventive effect of Clopidogrel on the systemic sclerosis development risk
    Effet préventif du Clopidogrel sur l’évolution vers une sclérodermie systémique
    A.3.2Name or abbreviated title of the trial where available
    PSSIT
    PSSIT
    A.4.1Sponsor's protocol code numberCHUBX2017/45
    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 supportMinistère de la Santé
    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 pointREC - Laetitia LACAZE-BUZY
    B.5.3 Address:
    B.5.3.1Street Address12 rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number33557821134
    B.5.5Fax number33559794926
    B.5.6E-maillaetitia.lacaze-buzy@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 Plavix
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis France
    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 nameCLOPIDOGREL
    D.3.4Pharmaceutical form Capsule
    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
    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
    Raynaud phenomenon
    phénomène de Raynaud
    E.1.1.1Medical condition in easily understood language
    Raynaud phenomenon
    phénomène de Raynaud
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037914
    E.1.2Term Raynaud's syndrome
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the onset of a SSc after 5 years in patients with specific dysimmunity and RP treated either with clopidogrel or with placebo.
    Comparer la survenue à 5 ans d’une ScS chez des sujets présentant une association de phénomène de Raynaud et d’une dysimmunité spécifique, ayant reçu pendant 2 ans un traitement préventif par clopidogrel versus placebo.
    E.2.2Secondary objectives of the trial
    - To compare after 2 and 5 years the onset of a skin fibrosis in patients with specific dysimmunity and RP treated either with clopidogrel or with placebo.
    - To compare after 2 and 5 years the extent of skin fibrosis in patients with specific dysimmunity and RP treated either with clopidogrel or with placebo.
    - To compare after 2 and 5 years the risk of degradation of the Cochin Hand Function Scale in patients with specific dysimmunity and RP treated either with clopidogrel or with placebo.
    - Assessment of clinical, demographic, biologic or capillaroscopic prognosis factors associated with a higher risk to develop an SSc when presenting with specific dysimmunity and RP.
    - Comparer à 2 ans et 5 ans le risque d’apparition d’une fibrose cutanée chez des sujets présentant une association de phénomène de Raynaud et d’une dysimmunité spécifique, ayant reçu pendant 2 ans un traitement préventif par clopidogrel versus placebo.
    - Comparer à 2 ans et 5 ans l’étendue de la fibrose cutanée chez des sujets présentant une association de phénomène de Raynaud et d’une dysimmunité spécifique, ayant reçu pendant 2 ans un traitement préventif par clopidogrel versus placebo.
    - Comparer dans les 2 groupes à 2 ans et 5 ans le risque de dégradation du score de la main de Cochin.
    - Evaluer d’autres marqueurs (démographiques, cliniques, biologiques, capillaroscopiques) associés à une évolution vers une ScS chez des sujets présentant une association dysimmunité spécifique/phénomène de Raynaud traités par clopidogrel versus placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient over 18 years old, and less than 85 years old.
    - Patient with positive AAN (AAN ≥ 1/160) with the following specificity: anti-Scl70 or anti-centromere or anti-RNApolIII.
    - Patient with RP reported by the subject and confirmed by the physician.
    - Patient affiliated to a health insurance system.
    - Patient who accepts to participate to the study and signs an inform consent form.
    - Patient âgé de plus de 18 ans et de moins de 85 ans ;
    - Patient présentant un taux d’ACAN positifs (≥1/160) de spécificité anti-Scl70, anti-centromères ou anti-ARNPolIII ;
    - Patient présentant un phénomène de Raynaud rapporté par le sujet et confirmé par l’interrogatoire d’un médecin ;
    - Sujet affilié ou bénéficiaire d’un régime de Sécurité Sociale ;
    - Consentement libre, éclairé et écrit signé par le participant et l’investigateur (au plus tard le jour de l’inclusion et avant tout examen nécessité par la recherche).
    E.4Principal exclusion criteria
    - Patient with an SSc diagnosis according to ACR/EULAR 2013 criteria.
    - Patient with skin fibrosis at screening.
    - Patient with antiplatelet treatment at screening.
    - Patient with contraindications to clopidogrel.
    - Patient treated by immunosuppressive agent at screening.
    - Pregnant or breastfeeding women.
    - Women of childbearing age refusing effective contraception method during the study.
    - Incompetent adults (i.e. Individuals under the protection of a conservator)
    - Patient présentant un diagnostic de ScS selon les critères ACR/EULAR 2013 ;
    - Patient présentant une fibrose cutanée à la visite de sélection ;
    - Patient traité par antiagrégant plaquettaire en cours à la visite de sélection ;
    - Patient présentant une contre-indication au clopidogrel listée dans le résumé des caractéristiques du produit :
    o Hypersensibilité à la substance active ou à l’un des excipients
    o Insuffisance hépatique sévère
    o Lésion hémorragique évolutive telle qu’un ulcère gastroduodénal ou une hémorragie intracrânienne
    - Patient traité par un traitement immunosuppresseur à la visite de sélection ;
    - Femme enceinte ou allaitante ;
    - Femme en capacité de procréer, et refusant d’utiliser une méthode de contraception efficace (critères HAS) pendant toute la durée de l’étude ;
    - Patient visé aux articles L 1121-5 à L 1121-8 (personnes privées de liberté par une décision judiciaire ou administrative, mineurs, personnes majeures faisant l'objet d'une mesure de protection légale ou hors d'état d'exprimer leur consentement.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of SSc at 5 years according to ACR / EULAR 2013 criteria in the two randomization groups
    Survenue d’une ScS à 5 ans selon les critères ACR/EULAR 2013 dans les deux groupes de randomisation
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 months after baseline
    60 mois après l'inclusion
    E.5.2Secondary end point(s)
    - Frequency of occurrence of cutaneous fibrosis (sclerodactyly or other affected area) clinically assessed by at least 2 independent investigators in the two randomization groups
    - Mean of modified Rodman skin score in the two randomization groups
    - Mean of Cochin Hand Function Scale in the two randomization groups
    - Demographic (sex, age, environmental factors), clinical (associated diseases, history), biological, capillaroscopic criteria in the two randomization groups
    - Fréquence de survenue d’une fibrose cutanée (sclérodactylie ou autre zone atteinte) évaluée cliniquement par au moins 2 investigateurs indépendants dans les deux groupes de randomisation
    - Moyenne du score de Rodnan modifié dans les deux groupes de randomisation
    - Moyenne du score de la main de Cochin dans les deux groupes de randomisation à 2 ans et 5 ans
    - Critères démographiques (sexe, âge, facteurs d’environnement), cliniques (maladies associées, antécédents), biologiques, capillaroscopiques dans les deux groupes de randomisation
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 months after baseline
    60 mois après l'inclusion
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 concerned7
    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 (DVDP)
    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 months84
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months84
    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: 80
    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 state90
    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
    Aucune
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-25
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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